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	<title>Surgical Archives | Medical Device News by Guided Solutions</title>
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		<title>CMR Surgical and Nvidia collab to train next-gen surgical robots</title>
		<link>https://news.gsmedtech.com/cmr-surgical-and-nvidia-collab-next-gen-surgical-robots/</link>
		
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		<pubDate>Tue, 17 Mar 2026 08:23:10 +0000</pubDate>
				<category><![CDATA[Partnerships]]></category>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=20352</guid>

					<description><![CDATA[<p>CMR Surgical announced a new effort with Nvidia to train the next generation of intelligent surgical systems. The Cambridge, U.K.–based based surgical robot developer unveiled its participation in Nvidia’s Physial AI healthcare robotics initiative at Nvidia GTC. As part of the initiative, the company contributed the majority of surgical data used to create Open-H, the [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/cmr-surgical-and-nvidia-collab-next-gen-surgical-robots/">CMR Surgical and Nvidia collab to train next-gen surgical robots</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>CMR Surgical announced a new effort with Nvidia to train the next generation of intelligent surgical systems.</p>
<p>The Cambridge, U.K.–based based surgical robot developer unveiled its participation in Nvidia’s Physial AI healthcare robotics initiative at Nvidia GTC. As part of the initiative, the company contributed the majority of surgical data used to create Open-H, the world’s largest open dataset for healthcare robotics.</p>
<p><a href="https://news.gsmedtech.com/nyxoah-expanding-its-belgian-manufacturing-capacity/">Related: Nyxoah invests in further expanding its Belgian manufacturing capacity</a></p>
<p>According to CMR Surgical, the dataset combines real-world surgical video, robotic telemetry and multimodal data. The company contributed close to 500 hours of anonymized surgical data from its Versius surgical robotic system.</p>
<p>This marks the latest collaboration between CMR Surgical and Nvidia, a leader in AI and cloud computing. Last fall, the company became an early adopter of Nvidia’s IGX Thor platform for surgical robotics. Johnson &amp; Johnson MedTech, Karl Storz’s Asensus, Moon Surgical, Virtual Incision, Neptune Surgical and Stereotaxis also have ongoing surgical robotic collaborations with Nvidia.</p>
<p>CMR Surgical said the Open-H initiative underpins Isaac GRooT-H, the first open vision-language action model for healthcare robotics. Technologies in the effort aim to accelerate the development of intelligent robotic systems while maintaining safety and clinical oversight.</p>
<p>The company said that Nvidia physical AI infrastructure enables the training and evaluation of robotic systems in simulated environments before deployment to help accelerate deployment while maintaining safety standards, using Versius data to deliver this.</p>
<p>Versius, a digitally enabled surgical platform, became the first multi-port, soft tissue general robotic-assisted surgical device to gain clearance through the FDA’s de novo process just over a year ago. The small-scale surgical robotic system features collaborative arms and bedside units for direct patient access. It also features offers of port placement to best suit the needs of each patient.</p>
<p>CMR Surgical said its contribution of anonymized data can support broader innovation across the healthcare robotics community.</p>
<p>Chris Fryer, chief technology officer at CMR Surgical, said:</p>
<p>“Surgical robotics generates a rich understanding of how procedures are performed. By contributing real‑world surgical data to collaborative initiatives like Open‑H, we are helping build the foundations for the next generation of intelligent surgical systems. Because Versius is the most software-driven robot on the market, we were well-placed to share our data with the wider ecosystem. Our focus is on technologies that support surgeons and expand access to minimally invasive surgery. Combining clinical data with advances in AI and simulation creates a powerful opportunity to accelerate innovation responsibly.”</p>
<p>David Niewolny, head of business development for Healthcare and Medical Technology at NVIDIA, said:</p>
<p>“The next generation of surgical robotics will be powered by data, simulation and AI working together. By responsibly contributing surgical data and training open models on NVIDIA’s physical AI platform, medical technology leaders like CMR Surgical are accelerating a new generation of intelligent robotic systems that can assist surgeons, scale surgical expertise and ultimately expand access to high-quality care.”</p>
<p>The post <a href="https://news.gsmedtech.com/cmr-surgical-and-nvidia-collab-next-gen-surgical-robots/">CMR Surgical and Nvidia collab to train next-gen surgical robots</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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		<title>Tuodao Medical launches with surgical robot technology</title>
		<link>https://news.gsmedtech.com/tuodao-medical-launches-surgical-robot-technology/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Mon, 08 Dec 2025 07:27:08 +0000</pubDate>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=19733</guid>

					<description><![CDATA[<p>Tuodao Medical announced its launch as a developer of robotic solutions for intelligent medical care. The China-based company wants to make surgery easier through advanced technologies. Those include data algorithms, AI and high-precision intelligent control, all combined in surgical robotic technology. Related: Micro-X to debut mobile X-ray system at RSNA 2025 Tuodao said on LinkedIn [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/tuodao-medical-launches-surgical-robot-technology/">Tuodao Medical launches with surgical robot technology</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Tuodao Medical announced its launch as a developer of robotic solutions for intelligent medical care. The China-based company wants to make surgery easier through advanced technologies. Those include data algorithms, AI and high-precision intelligent control, all combined in surgical robotic technology.</p>
<p><a href="https://news.gsmedtech.com/micro-x-to-debut-mobile-x-ray-system-at-rsna-2025/">Related: Micro-X to debut mobile X-ray system at RSNA 2025</a></p>
<p>Tuodao said on <a href="https://www.linkedin.com/posts/tuodao-medical-technology-co-ltd_surgicalrobotics-medtech-aiinhealthcare-activity-7401464403835219969-8iAP/">LinkedIn</a> that it has built a “robust core technology platform” for surgical robotics. It launches with a roadmap targeting five major surgical robot fields. The company said its robotic pipeline includes orthopedics, general surgery, gynecology, urology, respiratory medicine and imaging.</p>
<p>Tuodao said it plans to connect with strategic commercial partners and leading medical centers globally with its launch.</p>
<p>“We’re actively developing solutions that cross departmental boundaries, driving innovation in surgical techniques,” the company wrote. “We are committed to building the Tuodao Medical Integrated Remote Intelligent Medical Center and achieving full-field product pipelines.”</p>
<p>This marks the latest surgical robot launch out of China, as the country continues to innovate in the field led for decades by Intuitive Surgical, with Medtronic’s Hugo platform also recently making a splash with FDA clearance for urologic procedures.</p>
<p>The post <a href="https://news.gsmedtech.com/tuodao-medical-launches-surgical-robot-technology/">Tuodao Medical launches with surgical robot technology</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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		<title>FDA clears Levita’s Magnetic Surgical System for pediatric use</title>
		<link>https://news.gsmedtech.com/fda-clears-levitas-magnetic-surgical-system-pediatric-use/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Wed, 19 Nov 2025 08:05:38 +0000</pubDate>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=19616</guid>

					<description><![CDATA[<p>Levita Magnetics has received FDA 510(k) clearance for its Magnetic Surgical System (MSS) to be used in certain pediatric surgeries, with the first U.S. surgery performed at Cleveland Clinic Children’s earlier this month. The latest MSS clearance is for laparoscopic cholecystectomies in pediatric patients ages 12 and older within a BMI range of 20-34 kg/m². [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/fda-clears-levitas-magnetic-surgical-system-pediatric-use/">FDA clears Levita’s Magnetic Surgical System for pediatric use</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Levita Magnetics has received FDA 510(k) clearance for its Magnetic Surgical System (MSS) to be used in certain pediatric surgeries, with the first U.S. surgery performed at Cleveland Clinic Children’s earlier this month. The latest MSS clearance is for laparoscopic cholecystectomies in pediatric patients ages 12 and older within a BMI range of 20-34 kg/m².</p>
<p>“For pediatric patients, minimizing surgical trauma is critical — less pain, faster recovery, and fewer scars all contribute to better long-term physical and emotional outcomes,” said Dr. Miguel Guelfand, professor and head of pediatric general and thoracic surgery at Cleveland Clinic Children’s.</p>
<p><a href="https://news.gsmedtech.com/zimmer-biomet-fda-approval-rosa-knee/">Related: Zimmer Biomet secures FDA approval for ROSA Knee with OptimiZe system</a></p>
<p>Guelfand was part of the team that conducted that first pediatric cholecystectomy using MSS with Levita’s MARS (magnetic-assisted robotic surgery) system on Nov. 6. “This case represents a major step forward in our ongoing mission to advance minimally invasive and robotic surgery in neonates and children,” Guelfand said on LinkedIn after the first surgery. “The MARS system combines the advantages of magnetic retraction with robotic control, allowing greater visualization and dexterity through less incisions — a true paradigm shift for pediatric patients. … This is only the beginning — and a glimpse into the future of pediatric MIS and robotic surgery.”</p>
<p>Mountain View, California–based Levita launched MSS in 2016. MSS is comprised of a laparoscopic magnetic grasper, a grasper tip that attaches to tissue inside the body, and an external magnetic controller that attracts the grasper tip to manipulate the attached tissue.</p>
<p>The MSS magnetic controller can be attached to the robotic arm on Levita’s MARS system, which won FDA 510(k) clearance in 2023 and was soon after used for the first time commercially at the Cleveland Clinic. That system uses magnets and robotics to reduce the number of incisions required in laparoscopic procedures and give surgeons even more control when using MSS. The latest MSS clearance “marks a defining moment for the future of surgery,” Levita Magnetics founder, CEO and President Dr. Alberto Rodriguez-Navarro said in a statement shared with MassDevice ahead of the announcement.</p>
<p>“By expanding magnetic-assisted, minimally invasive surgery to children, we’re setting a new standard in safety and recovery — reducing trauma, accelerating healing, and improving quality of life for patients and families,” he said. “This is not just technological progress; it’s progress in compassion. Our vision is a future where every patient, regardless of age, benefits from safer, more intelligent, and truly human-centered surgical care.”</p>
<p>The post <a href="https://news.gsmedtech.com/fda-clears-levitas-magnetic-surgical-system-pediatric-use/">FDA clears Levita’s Magnetic Surgical System for pediatric use</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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		<title>FDA clears Augmedics’ AR headset for use with spine surgery system</title>
		<link>https://news.gsmedtech.com/fda-clears-augmedics-ar-headset-spine-surgery/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Mon, 17 Nov 2025 08:07:51 +0000</pubDate>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=19600</guid>

					<description><![CDATA[<p>The US Food and Drug Administration (FDA) has granted 510(k) clearance to Augmedics’ new augmented reality (AR) headset, X2, designed for use with the xvision Spine System. The X2 is purpose-built for operating rooms and is distinct from mainstream AR headsets designed for wider consumer applications. Its key features include a detachable, surgical-grade headlight and [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/fda-clears-augmedics-ar-headset-spine-surgery/">FDA clears Augmedics’ AR headset for use with spine surgery system</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>The US Food and Drug Administration (FDA) has granted 510(k) clearance to Augmedics’ new augmented reality (AR) headset, X2, designed for use with the xvision Spine System.</p>
<p>The X2 is purpose-built for operating rooms and is distinct from mainstream AR headsets designed for wider consumer applications.</p>
<p>Its key features include a detachable, surgical-grade headlight and a new lens tilt function to accommodate various surgeon positions, whether standing or seated.</p>
<p><a href="https://news.gsmedtech.com/fda-clears-vitaa-medicals-ai-aortic-surgery-planning-tool/">Related: FDA clears ViTAA Medical’s AI aortic surgery planning tool</a></p>
<p>The AR display now delivers increased field of view and image resolution compared with the earlier version, with a notable enhancement in brightness.</p>
<p>Technological improvements in the X2 include a high-performance processor and a focus on energy efficiency, further advancing Augmedics’ initial generation of the headset.</p>
<p>The company will introduce the new device at the North American Spine Society (NASS) Annual Meeting in Denver, US, on 14 November.</p>
<p>According to Augmedics, delivery to customers will only proceed once the necessary equipment authorisation process through the US Federal Communications Commission (FCC) is complete.</p>
<p>FCC regulations do not cover provisions related to consumer protection, contracts, or other federal or state legal requirements.</p>
<p>Augmedics CEO and president Paul Ziegler said: “Augmedics was a pioneer in the field with the first AR guidance system to be used in surgery. We have continued to be a leader in the space with more than 12,000 patients treated with our first-generation technology.</p>
<p>“With that foundation established, we’re entering a new era in Augmedics history. X2 is a significant step forward and represents a proprietary platform for long-term procedural innovation.”</p>
<p>Augmedics’ xvision Spine System enables surgeons to visualise internal anatomy, supporting navigation of instruments and implants during spinal operations.</p>
<p>Since its launch, the system is claimed to have been used for more than 65,000 pedicle screw placements across 25 US states. Last year, the company gained FDA clearance for a CT-to-fluoroscopy registration method for its xvision Spine System.</p>
<p>The post <a href="https://news.gsmedtech.com/fda-clears-augmedics-ar-headset-spine-surgery/">FDA clears Augmedics’ AR headset for use with spine surgery system</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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		<title>XCath reports first human use of neuro-endovascular surgical robot</title>
		<link>https://news.gsmedtech.com/xcath-first-human-use-neuro-endovascular-surgical-robot/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Thu, 13 Nov 2025 07:53:05 +0000</pubDate>
				<category><![CDATA[Innovation]]></category>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=19581</guid>

					<description><![CDATA[<p>XCath announced the successful first-in-human use of its EVR robotic system to treat three patients with complex brain aneurysms. The procedures took place at The Panama Clinic in Panama City, Panama. Dr. Vitor Mendes Pereira led the cases along with local principal investigator Dr. Anastasio Ameijeiras Sibauste. “With the success of these aneurysm procedures, XCath’s [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/xcath-first-human-use-neuro-endovascular-surgical-robot/">XCath reports first human use of neuro-endovascular surgical robot</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>XCath announced the successful first-in-human use of its EVR robotic system to treat three patients with complex brain aneurysms. The procedures took place at The Panama Clinic in Panama City, Panama. Dr. Vitor Mendes Pereira led the cases along with local principal investigator Dr. Anastasio Ameijeiras Sibauste.</p>
<p>“With the success of these aneurysm procedures, XCath’s system has demonstrated the potential to enhance human performance and bring a new level of precision to complex neurovascular cases,” Pereira said. “By standardizing fine movements and decision execution, robotic assistance can help transform even junior or less experienced physicians into consistent, low-risk interventionists—ultimately improving outcomes and minimizing complications.”</p>
<p><a href="https://news.gsmedtech.com/sentante-first-remote-robotic-stroke-procedure/">Related: Sentante announces first-of-its-kind remote robotic stroke procedure</a></p>
<p>Houston-based XCath said it marks the second time a surgical robot was used in an intracranial neurovascular intervention. The company said it makes its EVR system the only endovascular robotic system currently in development that achieved intracranial navigation or neurointerventional treatment. It also makes it the world’s first triaxial neurovascular robot to perform treatment, according to a news release.</p>
<p>Dr. Fred Moll, cofounder of surgical robotics leader Intuitive Surgical and the man widely considered the “father of surgical robotics,” is the chair of XCath’s board. The company is targeting a space that has generated recent interest, including a partnership between Stryker and Siemens Healthineers.</p>
<p>“It was exciting to witness this momentous occasion,” Moll said. “The successful completion of these procedures marks a significant milestone in the world of endovascular robotics as we seek to improve outcomes for patients impacted by aneurysms and strokes. These conditions affect a significant patient population, and the ability to perform such intricate robotic interventions has the potential to revolutionize treatment for these vulnerable individuals.”</p>
<p>EVR, designed as a bedside endovascular device manipulator for local procedures, enables control over various devices through a console. It can deliver sub-millimeter precision robotic control with an innovative configuration, according to XCath’s website.</p>
<p>The company designed EVR for compatibility with a range of guidewires, catheters and treatment devices. Its cassette controller uses a dexterous positioning arm, easily installed using the system cart. A remote physician unit can also reduce radiation exposure, while interventionalists can avoid exerting continuous force on the musculoskeletal system.</p>
<p>XCath performed the first public demonstration of a simulated, remote mechanical thrombectomy (MT) in 2024. Pereira performed that procedure from AbuDhabi on a simulated patient in South Korea. He removed a blood clot in the brain in minutes. The company then conducted the world’s first telerobotic MT on an animal in February 2025, it says. Earlier this year, it partnered with Nvidia to advance its surgical robot as well.</p>
<p>In the cases completed in Panama, physicians navigated EVR precisely through the patient’s brain vessels. They performed three aneurysm treatments using commercially available flow-diverting stents and intrasaccular devices made by different device manufacturers. The physicians used standard endovascular access devices throughout the procedures.</p>
<p>Two robot procedures took place consecutively in the same operating room over a period of just over four hours. XCath said it marked the world’s first neurovascular robotic procedures with a monoplane angiographic imaging system.</p>
<p>“Unlocking clinical and commercial value in neurointervention starts with making life-saving intracranial care more replicable, more precise and more accessible when every minute counts,” said Eduardo Fonseca, CEO of XCath. “As we look to the future, the success of a trial with this level of clinical complexity lays a strong foundation for commercially viable local and telerobotic neurointerventions that improve patient outcomes.”</p>
<p>The post <a href="https://news.gsmedtech.com/xcath-first-human-use-neuro-endovascular-surgical-robot/">XCath reports first human use of neuro-endovascular surgical robot</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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		<title>Sovato raises Series B funds to advance remote robotic surgery platform</title>
		<link>https://news.gsmedtech.com/sovato-funding-advance-remote-robotic-surgery/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Thu, 06 Nov 2025 08:32:53 +0000</pubDate>
				<category><![CDATA[Funding]]></category>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=19546</guid>

					<description><![CDATA[<p>Sovato has closed a Series B funding round to scale its remote robotic surgery (telesurgery) platform. Led by VC business Beringea, the round brings Sovato’s funding to date to $41m. Other participating investors included Teladoc Health, GS Ventures, and Laerdal Million Lives Fund. Sovato did not immediately respond to Medical Device Network when asked to [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/sovato-funding-advance-remote-robotic-surgery/">Sovato raises Series B funds to advance remote robotic surgery platform</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Sovato has closed a Series B funding round to scale its remote robotic surgery (telesurgery) platform.</p>
<p>Led by VC business Beringea, the round brings Sovato’s funding to date to $41m. Other participating investors included Teladoc Health, GS Ventures, and Laerdal Million Lives Fund.</p>
<p>Sovato did not immediately respond to Medical Device Network when asked to confirm the Series B amount.</p>
<p><a href="https://news.gsmedtech.com/precision-neuroscience-investment-sci-ventures/">Related: Precision Neuroscience gains investment from paralysis-focused VC</a></p>
<p>The company’s system-agnostic platform enables surgical, interventional, or diagnostic robotic systems that allow physicians to perform procedures remotely.</p>
<p>While Sovato’s platform is yet to undergo review by the US Food and Drug Administration (FDA), the company has already touted the successful rate of its platform in facilitating the completion of a series of remote robotic-assisted surgery (RAS) procedures. This was across a 500-mile distance as part of a preclinical technology demonstration in June 2024.</p>
<p>The company said it plans to use the latest funding towards advancing the development of its platform, along with forging new strategic partnerships with entities, including surgical robotics companies, healthcare providers, and related ecosystem collaborators.</p>
<p>Sovato co-founder and CEO Cynthia Perazzo commented: “Over half the world’s population lacks access to timely, safe surgical care, and in the US, millions are still forced to travel for routine procedures – a challenge that will only grow as surgeon shortages intensify.</p>
<p>Some forecasts estimate that the surgeon shortfall in the US may reach almost 20,000 by 2036, with the impending crisis thought to come down to factors including the cap on federally funded surgical trainees, and an anticipated surge in retirement rates.</p>
<p>According to a GlobalData market model, the overall global robotic surgical systems market is growing at a compound annual growth rate (CAGR) of 12.1% and is projected to reach a valuation of $9.2bn by 2034, up from $2.9bn in 2024.</p>
<p>Perazzo continued: “Remote robotic surgery and procedure programmes provide healthcare organisations with a practical way to extend the reach and impact of skilled surgeons, care teams, and operating rooms, enabling a more sustainable and accessible model of care.”</p>
<p>The post <a href="https://news.gsmedtech.com/sovato-funding-advance-remote-robotic-surgery/">Sovato raises Series B funds to advance remote robotic surgery platform</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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		<title>Medical Microinstruments wins FDA IDE for robotic microsurgery for Alzheimer’s</title>
		<link>https://news.gsmedtech.com/medical-microinstruments-fda-ide-robotic-microsurgery-alzheimers/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Thu, 06 Nov 2025 08:09:35 +0000</pubDate>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=19539</guid>

					<description><![CDATA[<p>Medical Microinstruments (MMI) announced it received FDA investigational device exemption (IDE) to study its microsurgery platform. The FDA granted the IDE for a clinical study evaluating microsurgery intervention for Alzheimer’s disease. The REMIND (robotic-enabled microsurgical intervention for neurodegenerative disease) study will collect safety and effectiveness data for the Symani surgical robot system and microsurgical techniques. [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/medical-microinstruments-fda-ide-robotic-microsurgery-alzheimers/">Medical Microinstruments wins FDA IDE for robotic microsurgery for Alzheimer’s</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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										<content:encoded><![CDATA[<p>Medical Microinstruments (MMI) announced it received FDA investigational device exemption (IDE) to study its microsurgery platform.</p>
<p>The FDA granted the IDE for a clinical study evaluating microsurgery intervention for Alzheimer’s disease. The REMIND (robotic-enabled microsurgical intervention for neurodegenerative disease) study will collect safety and effectiveness data for the Symani surgical robot system and microsurgical techniques. It evaluates Symani in reestablishing lymphatic drainage pathways in the deep cervical lymph nodes (dCLNs). Subjects have Alzheimer’s and confirmed lymphatic obstruction.</p>
<p><a href="https://news.gsmedtech.com/aqua-medical-fda-ide-trial-ablation-procedure-diabetes/">Related: Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes</a></p>
<p>Symani provides advanced solutions for a range of open surgeries. That includes post-mastectomy breast cancer reconstruction, extremity reconstruction using free tissue transfer and lymphatic system repair. The company’s tiny NanoWrist instruments help to access and suture small, delicate anatomies.</p>
<p>Medical Microinstruments won FDA de novo clearance for Symani, covering soft tissue manipulation to perform microsurgery, in April 2024. The company has since reported a number of milestones for Symani, including the world’s first robotic microsurgical intracranial brain surgery. Last month, the company enrolled the first patient in a study for free flap reconstruction and lymphatic repair procedures.</p>
<p>“This FDA approval is more than a milestone for our company—it’s a signal of what’s possible in science when we bring together the right experts, technology, and research,” said Mark Toland, CEO of MMI. “We’re at the threshold of a new era in microsurgery; one where robotic precision could play a central role in unlocking novel treatment pathways for devastating diseases like Alzheimer’s. With REMIND, we’re just beginning to explore the extraordinary potential of robotic lymphatic intervention in redefining a critical standard of care.”</p>
<p>The REMIND feasibility study has a primary endpoint of device-related serious adverse events through 30 days post-procedure. Additional endpoints include adverse events, biomarker and imaging changes and cognitive assessments through six months.</p>
<p>According to a news release, recent discoveries demonstrated the need to understand lymphatic vessels in the central nervous system. Medical Microinstruments said robotics could further enable this potential therapeutic pathway for neurodegenerative diseases. It says the method could improve the clearance of harmful proteins like amyloid beta and tau. It could also serve as a treatment for Alzheimer’s disease.</p>
<p>The company says that very few surgeons can dissect and suture the small, delicate lymphatic vessels in a reproducible manner without robotic assistance. Medical Microinstruments’ approach involves establishing a precise connection of lymphatic vessels or lymphatic nodes in the neck to neighboring veins using Symani. This would enable the draining of neurotoxins from the brain and could support reduced variability in outcomes.</p>
<p>Medical Microinstruments plans to partner with leading research institutions in the U.S. and Europe for the study. It aims to initiate patient enrollment in REMIND “in the very near future.”</p>
<p>“The REMIND study offers the potential to open an entirely new chapter in the treatment of neurodegenerative disease,” added Kate Rumrill, chief scientific officer of MMI. “Bringing robotic precision to more surgeons stands to change patient lives and medicine. Initiating such critical research may help pave the way for further studies to explore the promise of lymphatic microsurgery in improving the lives of more than 7 million Americans impacted by Alzheimer’s and bringing renewed hope to the caregivers who support them every day.”</p>
<p>The post <a href="https://news.gsmedtech.com/medical-microinstruments-fda-ide-robotic-microsurgery-alzheimers/">Medical Microinstruments wins FDA IDE for robotic microsurgery for Alzheimer’s</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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		<title>Hyperion completes first-in-human study of Ivy robotic vascular access platform</title>
		<link>https://news.gsmedtech.com/hyperion-first-in-human-study-ivy-robotic-vascular-access-platform/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Thu, 30 Oct 2025 08:14:47 +0000</pubDate>
				<category><![CDATA[Clinical Trials]]></category>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=19500</guid>

					<description><![CDATA[<p>Hyperion Surgical announced today that it completed the world’s first robotic-assisted intravenous (IV) catheterisation using its Ivy platform. Ivy integrates advanced imaging, AI and robotic precision in a robotic vascular access platform to enable a no-touch approach to IV placements. Miami-based Hyperion’s clinical team performed the procedure in a first-in-human clinical study earlier this year. [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/hyperion-first-in-human-study-ivy-robotic-vascular-access-platform/">Hyperion completes first-in-human study of Ivy robotic vascular access platform</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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										<content:encoded><![CDATA[<p>Hyperion Surgical announced today that it completed the world’s first robotic-assisted intravenous (IV) catheterisation using its Ivy platform.</p>
<p>Ivy integrates advanced imaging, AI and robotic precision in a robotic vascular access platform to enable a no-touch approach to IV placements. Miami-based Hyperion’s clinical team performed the procedure in a first-in-human clinical study earlier this year.</p>
<p>The company says it marks the first clinical use of a robotic-assisted system for peripheral IV catheterisation.</p>
<p><a href="https://news.gsmedtech.com/atricure-first-patient-boxx-noaf-clinical-trial/">Related: AtriCure treats first patient in the BoxX-NoAF clinical trial</a></p>
<p>Hyperion said it aims for Ivy to address the long-standing clinical challenge of high variability and failure rate in IV placements. Its design enables the placement of the catheter — not just the needle — into the blood vessel.</p>
<p>Ivy, a semi-autonomous system, offers high-quality imaging guidance using direct, continuous visualization and AI vessel recognition along with robotic insertion and stabilization. Current handheld devices require significant psychomotor skills to continuously manually stabilize the ultrasound probe and needle. Instead, Ivy holds the probe and needle itself, while performing the catheter insertion without user contact.</p>
<p>Hyperion said this could enable a no-touch technique to lower the cognitive and coordination demands for image-guided IV placements. The system also has scalability, thanks to its rapid setup and procedure times, the company says.</p>
<p>Next, the company plans to submit Ivy to the FDA and anticipates additional clinical evaluations for the platform. It hopes to begin commercialisation within the next 18 months.</p>
<p>“No patient should ever be stuck more than once to place an IV. It’s long past time that we recognised that difficult-to-stick patients need a different paradigm,” said Dr. Eric Peterson, founder and CEO of Hyperion Surgical. “Completing our first-in-human study represents the culmination of years of engineering, design, and clinical collaboration. We believe robotic and AI-assisted vascular access has the potential to deliver new levels of consistency, confidence, and predictability for clinicians and patients.”</p>
<p>The post <a href="https://news.gsmedtech.com/hyperion-first-in-human-study-ivy-robotic-vascular-access-platform/">Hyperion completes first-in-human study of Ivy robotic vascular access platform</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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		<title>Spectral AI raises $7.6m additional growth capital for its DeepView System</title>
		<link>https://news.gsmedtech.com/spectral-ai-raises-growth-capital-deepview-system/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Mon, 27 Oct 2025 08:28:00 +0000</pubDate>
				<category><![CDATA[Funding]]></category>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=19470</guid>

					<description><![CDATA[<p>Spectral AI, an artificial intelligence company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced the pricing of a $7.6 million offering. The offering will provide the Company with additional growth capital for the continued expansion and development of its DeepView System. The transaction includes the issuance of [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/spectral-ai-raises-growth-capital-deepview-system/">Spectral AI raises $7.6m additional growth capital for its DeepView System</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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										<content:encoded><![CDATA[<p>Spectral AI, an artificial intelligence company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced the pricing of a $7.6 million offering. The offering will provide the Company with additional growth capital for the continued expansion and development of its DeepView System.</p>
<p>The transaction includes the issuance of 4,000,000 shares of its common stock and pre-funded warrants at a price of $1.90 per share and corresponding warrants with an exercise price of $2.51 per share of common stock.</p>
<p><a href="https://news.gsmedtech.com/vitvio-funding-ai-powered-digitisation-tech/">Related: VitVio raises $8M for AI-powered OR digitisation tech</a></p>
<p>J. Michael DiMaio, MD, Chairman of the Board of Spectral AI, said, “I am pleased that we were able to secure institutional funding for Spectral AI. This financing ensures that we can continue to develop and expand the DeepView System’s clinical indications and prepare for commercial readiness in 2026. We remain fully committed to supporting our current BARDA Project BioShield (PBS) contract, while also advancing our AI-powered technology to broaden our product offerings and deliver innovative solutions to the global medical community.”</p>
<p align="justify">Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns. Its DeepView System is being developed as a predictive device to offer clinicians an objective and immediate assessment of a burn wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, the DeepView System is expected to provide fast and accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs.</p>
<p>The post <a href="https://news.gsmedtech.com/spectral-ai-raises-growth-capital-deepview-system/">Spectral AI raises $7.6m additional growth capital for its DeepView System</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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		<title>CoMind raises $102.5M to support non-invasive brain monitoring tech</title>
		<link>https://news.gsmedtech.com/comind-raises-funding-support-non-invasive-brain-monitoring-tech/</link>
		
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		<pubDate>Wed, 22 Oct 2025 07:36:24 +0000</pubDate>
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		<guid isPermaLink="false">https://news.gsmedtech.com/?p=19433</guid>

					<description><![CDATA[<p>CoMind secured $102.5 million in funding to support its non-invasive brain monitoring system. The London-based company had its latest funding round led by Plural. Existing investors Angelini Ventures, LocalGlobe, Octopus Ventures, Crane, Backed VC and Entrepreneurs First joined as well. According to a news release, the company plans to use funds to advance regulatory efforts [&#8230;]</p>
<p>The post <a href="https://news.gsmedtech.com/comind-raises-funding-support-non-invasive-brain-monitoring-tech/">CoMind raises $102.5M to support non-invasive brain monitoring tech</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>CoMind secured $102.5 million in funding to support its non-invasive brain monitoring system.</p>
<p>The London-based company had its latest funding round led by Plural. Existing investors Angelini Ventures, LocalGlobe, Octopus Ventures, Crane, Backed VC and Entrepreneurs First joined as well.</p>
<p>According to a news release, the company plans to use funds to advance regulatory efforts for its first product, CoMind One. It also aims to complete additional clinical trials, expand its team and enter into new manufacturing partnerships.</p>
<p><a href="https://news.gsmedtech.com/hyperfine-prices-17-5m-offering/">Related: Hyperfine prices $17.5M offering</a></p>
<p>CoMind develops a non-invasive brain monitoring system designed to deliver real-time insight into cerebral perfusion, autoregulation and intracranial pressure. The platform uses infrared light technology centered around a simple adhesive sensor. According to the company, the sensor goes on the patient’s forehead, with ease of use and minimal training representing key design goals.</p>
<p>The company hopes to support clinicians with continuous brain physiology signals to inform decision-making across a range of settings. Those include cardiac and vascular surgery, intensive care and traumatic brain injury management. CoMind said its system can display signals on its own display platform or integrate into existing multiparameter monitors. It hopes to support seamless integration into existing clinical workflows.</p>
<p>CoMind says its offering could create an alternative to current brain monitoring options. Such options utilize risky procedures that require drilling into a skull or rely on innacurate non-invasive monitoring, the company says. Its platform delivers critical information about cerebral blood flow, cerebral autoregulation, and intracranial pressure easily and continually at the bed-side. The company says this allows clinicians to make life-saving decisions.</p>
<p>“We’re excited to advance our mission of redefining the way the brain is measured and treated,” CoMind said.</p>
<p>The post <a href="https://news.gsmedtech.com/comind-raises-funding-support-non-invasive-brain-monitoring-tech/">CoMind raises $102.5M to support non-invasive brain monitoring tech</a> appeared first on <a href="https://news.gsmedtech.com">Medical Device News by Guided Solutions</a>.</p>
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