Maple Grove, Minnesota-based Vdyne develops a transcatheter tricuspid valve replacement (TTVR) system. IDE approval enables the initiation of a U.S. pivotal study to test the valve’s safety and effectiveness in severe tricuspid regurgitation (TR).

Related: Butterfly Network wins FDA clearance for GA AI ultrasound tool

TR remains a significant unmet need, with a small percentage of patients suffering from the condition eligible for surgical treatment, the company says. It designed its TTVR system as a patient-tailored, minimally invasive solution to address the complexities of tricuspid valve anatomy and disease.

The company aims for the valve to conform to the patient’s tricuspid anatomy. It features proprietary side-delivery technology to support a wide range of valve sizes, treating more patients in need. Vdyne’s valve has a unique shallow delivery trajectory, plus a self-aligning design to simplify implantation and reduce imaging burden.

According to Vdyne, its valve optimizes positioning for full function evaluation prior to valve release. With no hooks or barbs used, it has full repositionability and retrievability. Additionally, the device minimizes structural exclusions and accommodates low right atrium height, right ventricle structures and previously implanted devices like leads. The company offers it in five sizes as well.

Vdyne reported first-in-human use of its valve replacement in November 2023. Since then, the company reports use globally throughout clinical studies and compassionate use, providing insights into outcomes.

If the device continues to progress, it could offer another TTVR option in a market that features the Edwards Evoque system. Other TTVR players include Venus Medtech’s Cardiovalve and TriCares.

Vdyne CEO Mike Buck said:
“This is a defining milestone for VDYNE and an important step toward bringing a much-needed therapy to patients with severe tricuspid regurgitation. Our focus now is on disciplined clinical execution and partnering with leading investigators to generate high-quality data that advances the field and improves patient care.”

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Burlington, Massachusetts–based Butterfly develops a single-probe, whole-body ultrasound system with seamless AI integration. Now, it can accurately assess GA to improve pregnancy care. This can address significant gaps in populations that lack hospital obstetric services and face socioeconomic barriers.

Related: Serenity Medical earns FDA HDE for cerebral venous stent

The company said it marks the first FDA-cleared blind-sweep ultrasound AI tool for estimating GA. It provides earlier identification in key prenatal screenings. This detects complications sooner, guides intervention and can improve outcomes for mothers and babies.

Butterfly said its GA tool builds on deep learning models developed by Dr. Jeffrey Stringer and his team at the University of North Carolina at Chapel Hill. It uses an AI-powered, blind-sweep method to deliver reliable GA estimates in under two minutes.

The feature uses a simple three-step process. First, users enter fundal height, then they apply gel, then perform sweeps.

Butterfly trained its GA tool on more than 21 million images across diverse patient demographics and care settings. It integrated its solution directly into the Butterfly app for availability across the globe.

Already deployed in Malawi and Uganda, Butterfly received support for the GA tool through a Gates Foundation grant. It said FDA clearance enables expedited pathways to expand across additional regions in Sub-Saharan Africa and across the U.S.

Dr. Sachita Shah, VP, Global Health, Butterfly Network, said:

“Improving maternal health outcomes and expanding access to prenatal imaging has become an urgent priority, and Butterfly is proud to be the first to bring this type of technology to mothers globally. With FDA clearance, we now have an AI-powered tool that can help transform maternal health, both worldwide and here in the U.S., by addressing longstanding gaps in access to timely, reliable imaging and enabling earlier, more informed care.”

Butterfly Chief Business Officer Steve Cashman said:

“The GA Tool is built to address three critical use cases: enabling faster decisions in emergency settings when gestational age is unknown; expanding access in countries where maternal and neonatal mortality remains high; and improving prenatal ultrasound access in rural U.S. communities, where patients may otherwise travel hours for imaging. Ultimately, it’s about helping clinicians act faster, earlier, and with greater confidence, at critical moments and in any setting.”

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Harrison, New York-based Serenity said approval makes River the first FDA-approved cerebral venous stent. The company specifically developed its technology for the treatment of severe idiopathic intracranial hypertension (IIH) in adult patients who have failed medical therapy.

Related: Medtronic wins CE mark for OmniaSecure pacemaker lead

IIH, caused by elevated intracranial pressure, leads to debilitating chronic headaches, vision loss and cognitive impairments. The company says it remains difficult to find appropriate, FDA-approved surgical therapies to safely relieve its symptoms.

According to a news release, the approval marks a landmark clinical milestone for the purpose-built tool. It helps address a condition that has “long challenged the neurovascular community and suffering patients,” Serenity said.

The company supported its approval with findings published in the Journal of Neurointerventional Surgery (JNIS) in February 2025. It enrolled 39 subjects across five U.S. centers, meeting its primary safety endpoint with an observed major adverse event rate of 5.4%. Investigators saw improvements in opening CSF pressure, headaches, papilledema, pulsatile tinnitus, visual symptoms and quality of life scores.

Serenity Medical said it formed a strategic partnership with Radical Catheter Technologies to commercialize the River stent. Humanitarian Device Exemption enables the use of River in adults with IIH with significant stenosis who are resistant or intolerant to medications.

Dr. Y. Pierre Gobin, founder of Serenity Medical, said:

“Delivering the first venous stent approved for severe, refractory IIH is incredibly meaningful to our dedicated team and to people living with IIH who have had limited options for relief until now. Our company was founded with the goal of addressing a problem that has long perplexed the medical community and caused debilitating symptoms in the women suffering with it. Reaching this moment reflects years of persistence, partnership with investigators, and a shared commitment to bring new possibilities to this underserved patient community.”

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Related: Neurovalens receives EU MDR compliance for sleep insomnia device

PH is a progressive, life-threatening pulmonary vascular disease estimated to affect up to 1% of the global population. It is often difficult to diagnose due to non-specific early symptoms, such as dyspnea, with delays frequently exceeding two years. These delays are associated with increased morbidity and mortality, highlighting the need for earlier detection. Anumana’s algorithm enhances the standard 12-lead ECG by detecting subtle abnormalities that may not be visible to the human eye, helping clinicians identify when follow-up testing, such as echocardiography, is warranted using existing clinical workflows.

“Pulmonary hypertension is often difficult to recognize until it has progressed significantly, leaving patients and physicians at a disadvantage,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic and a member of the Anumana advisory board. “FDA clearance of Anumana’s PH algorithm provides clinicians with a practical solution to identify PH earlier and determine appropriate next steps in care, expanding the clinical utility of routine ECGs.”

The PH algorithm helps clinicians identify subtle patterns associated with early PH in standard 12-lead ECGs. It integrates with EHR systems, including ECG management platforms, and runs entirely within the health system environment without transferring patient data.

“The FDA clearance of our Pulmonary Hypertension algorithm is the result of rigorous clinical development and regulatory work, and it marks a meaningful step toward expanding access to AI-enabled insights at the point of care,” said Simos Kedikoglou, President & COO of Anumana. “As the first PH algorithm cleared for use with standard 12-lead ECGs, it is broadly accessible across care settings, integrates directly into existing clinical workflows, and supports clinical decision-making in real time, with the potential to help identify patients earlier in their disease course. This milestone reflects Anumana’s broader vision to expand the role of ECGs in identifying cardiovascular risk earlier and at scale.”

With this clearance, Anumana continues to broaden its portfolio of AI-enabled, workflow-integrated solutions. The company is demonstrating clear leadership in advancing clinically validated solutions across geographies, delivering detectable, reliable insights to clinicians and patients in diverse care settings worldwide.

Anumana’s ECG-AI PH algorithm was developed using over 250,000 de-identified patient records from Mayo Clinic. In an independent, multi-center study of 21,066 patients across five U.S. health systems, ECG-AI detected PH with 73% sensitivity and 74.4% specificity in adult patients presenting with dyspnea. In a separate real-world analysis study of patients with an ECG available between symptom onset and PH diagnosis, ECG-AI identified more than 85% of patients with pulmonary arterial hypertension (PAH) and 78% with chronic thromboembolic pulmonary hypertension (CTEPH). This suggests a potential opportunity to support earlier detection of these two treatable PH subgroups.

Mayo Clinic co-founded Anumana and has a financial interest in the company.

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Applying to the Siemens Healthineers subsidiary’s systems including TrueBeam, TrueBeam STx, VitalBeam, and Edge, Varian highlighted that clearance expands its radiotherapy systems’ application beyond cancer care into chronic musculoskeletal conditions.

Related: JenaValve wins FDA nod for Trilogy heart valve system

Research indicates that OA affects around 33 million people in the US, with a rapid upswell in the condition’s incidence in the US and globally due to factors including ageing, obesity, and injury.

Varian highlighted that many patients manage OA symptoms with medications or other treatment options, yet a significant number continue to experience pain and reduced quality of life.

According to the company, for these individuals, the newly cleared indication offers an outpatient treatment option based on a growing body of evidence that that LDRT can “target inflammation at the source, reduce pain, improve joint function, and delay the need for surgical intervention”.

Varian head Arthur Kaindl commented: “This clearance is a powerful example of how we’re expanding the reach of precision radiotherapy to meet broader healthcare needs.

“At Siemens Healthineers, we’re uniquely positioned to lead this transformation by bringing imaging and therapy together to improve lives not just in cancer care, but now in chronic conditions like osteoarthritis.”

Past research has found that arthroscopic procedures, wherein a camera is inserted into OA-affected joints, enabling practitioners to remove damaged tissue, can slow the disease’s development by up to 25%.

Meanwhile, arthrosamid, an injectable hydrogel designed to alleviate knee OA pain, has shown promise in the the Observational Clinical Investigation of Arthrosamid in knee Osteoarthritis (LUNA) trial. The most common pharmaceutical options for OA are nonsteroidal anti-inflammatory drugs.

Formerly known as Varian Medical Systems, Siemens Healthineers acquired the California-based company in August 2020 for $16.4bn, from which point it became known as Varian.

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Trilogy, a transcatheter heart valve (THV) system, won approval for the treatment of patients with symptomatic, severe aortic regurgitation (AR) at high or greater risk for surgical aortic valve replacement (SAVR).

Related: Nia Therapeutics wins FDA breakthrough nod for neuromod

Trilogy is now the first and only transcatheter device approved in the U.S. with a dedicated indication for this patient population. The company says symptomatic, severe AR remains significantly undertreated while posing a life-altering threat to patients. Trilogy is already available in Europe.

Irvine, California-based JenaValve supported its PMA with results from the ALIGN-AR pivotal trial. The FDA investigational device exemption (IDE) trial demonstrated the safety and efficacy of Trilogy.

JenaValve now plans to begin launch activity for Trilogy immediately, starting with participating clinical study sites. It then plans to expand to new hospitals across the U.S.

“This FDA approval is the defining moment for JenaValve and, more importantly, those patients in the United States who have suffered from severe aortic regurgitation with nowhere to turn,” JenaValve CEO John Kilcoyne said. “For too long, high-risk AR patients were left with limited options. Our Trilogy valve changes that reality. Today marks the beginning of a new era in the treatment of aortic regurgitation in America, and we are grateful to the FDA, our investigators, the patients who participated in our clinical program, our investors and the entire JenaValve team whose years of extraordinary commitment made this possible.”

The long-awaited approval for Trilogy at one point looked set to provide a boost to Edwards, which agreed to acquire JenaValve for $1.2 billion in 2024. However, JenaValve will be moving forward with the valve itself after the deal fell through at the start of 2026.

In August 2025, the FTC sued to stop the deal from taking place, claiming the acquisition was anti-competitive. The FTC alleged that Edwards and JenaValve represented the only two companies in the U.S. evaluating their transcatheter aortic valve replacement (TAVR) technology for the treatment of AR.

Then, in January, Edwards announced that it would not go through with the JenaValve acquisition after a federal judge granted the FTC a preliminary injunction to halt the deal.

As JenaValve takes Trilogy to the market, Edwards continues the development of its Sojourn transcatheter valve for AR. Edwards is currently enrolling patients in the JOURNEY pivotal trial for the J-Valve system it acquired from JC Medical.

While major TAVR systems, such as Edwards Lifesciences’ Sapien valves and Medtronic’s Evolut valves, are primarily used to treat aortic stenosis (narrowing of the valve), Trilogy was designed for aortic regurgitation (a leaky valve).

The Trilogy system’s locator technology is meant to ensure commissural alignment, allowing the valve to attach to the native leaflets for secure anchoring, even in the absence of calcium. The locators go within the native cusps and resist ventricular migration.

Other Trilogy features include a self-expanding nitinol frame and porcine pericardial tissue with Jasmine proprietary tissue treatment. Trilogy has a large, open-cell design to enable future coronary access.

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The device won the breakthrough nod for the treatment of episodic memory loss in adult patients with prior moderate-to-severe traumatic brain injury (TBI) and persistent memory deficits.

Related: Perfuze wins FDA clearance for standalone aspiration catheter

According to a news release, SNS becomes the first device to receive breakthrough designation for TBI-related memory loss. The company says no current FDA-cleared or approved therapies exist to treat memory loss.

Nia Therapeutics designed its device to record neural activity from 60 channels across four brain regions. The company says this provides a significant increase over commercially available neurostimulation devices. It pointed to the NeuroPace RNS system (up to six channels) and the Medtronic Percept adaptive deep brain stimulation (DBS) system (up to four).

The AI-guided device uses machine learning classifiers trained on each patient’s own brain signals. It detects moments of impaired memory encoding in real time, then delivers targeted electrical stimulation to the lateral temporal cortex.

Nia says its closed-loop approach improved recall by 19% in a randomized, sham-controlled study of neurosurgical patients with epilepsy and a history of moderate-to-severe TBI. Randomly timed stimulation produced no benefit, the company said. This demonstrated the importance of therapy delivery at the right moment.

Breakthrough designation grants prioritized review and increased FDA interaction. Now, it plans to work toward an investigational device exemption (IDE) application for a first-in-human early feasibility study.

Michael Kahana, co-founder and CEO of Nia Therapeutics, said:

“The breakthrough designation validates the approach we’ve spent a decade building—that memory can be improved by listening to the brain and stimulating at precisely the right moment. This designation provides a framework to work closely with the FDA as we bring this technology from the laboratory into the clinic.”

Daniel Rizzuto, co-founder and CTO of Nia Therapeutics, said:

“Memory depends on coordinated activity across widespread brain networks—so we built a device that can sense and respond across the entire network. With 60 channels across four brain regions, the SNS offers an order of magnitude improvement over currently approved DBS devices.”

Dr. Ramon Diaz-Arrastia, Presidential Professor of Neurology and Director of the TBI Clinical Research Center at the University of Pennsylvania, and advisor to Nia Therapeutics, said:

“Patients with TBI-related memory loss represent a profoundly underserved population. Their disability is invisible but devastating—it affects the ability to work, maintain relationships, and live independently. We are committed to bringing them the first treatment that directly restores the capacity to form new memories.”

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Galway, Ireland-based Perfuze designed the catheter for rapid and complete clot removal in patients suffering from large vessel occlusion (LVO) strokes. The company aims to improve stroke treatment outcomes and reduce procedural complexity.

Related: Endo Tools Therapeutics receives FDA 510(k) clearance for EZFuse

Millipede88 features a patented corrugated catheter architecture designed to simplify navigation through the neurovascular anatomy. Its design helps to preserve inner lumen integrity to maintain maximum aspiration force at the face of the clot. Perfuze said it achieves high first-pass reperfusion rates and short procedure times in mechanical thrombectomy.

The company said its clearance follows the successful completion of the MARRS clinical study, which met all primary objectives. Clearance covers standalone direct aspiration, so physicians can achieve reperfusion with Millipede88 alone. The company said this potentially reduces procedural complexity, lowering per-case device costs and saving critical minutes for patients.

Perfuze believes clearance positions it as a leader in the super-bore aspiration segment in the mechanical thrombectomy market. Other stroke occlusion market players include catheter makers Johnson & Johnson MedTech (Cerenovus), Imperative Care, Terumo Neuro and Route 92 Medical. Boston Scientific (through its acquisition of Penumbra) and Medtronic (through its acquisition of Scientia) are also joining the neurovascular space soon.

The clearance also marks the first standalone 088 catheter indicated for direct aspiration, the company said. It builds on the company’s growing portfolio of technologies in the U.S, including the Zipline access catheter family.

“FDA clearance of the Millipede88 aspiration catheter is a defining moment for Perfuze and for the field of stroke intervention,” said Wayne Allen, CEO of Perfuze. “The MARRS study confirms what our team believed throughout development — that the corrugated design enables excellent first-pass reperfusion rates. With no other 0.088 catheter incorporating this technology, we believe Millipede88 will deliver meaningful clinical outcomes in everyday stroke procedures.”

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Related: Prodeon gets FDA clearance for BPH-treating nitinol implant

“The EZFuse system clearance marks an important milestone in the continued evolution of the endomina system and introduces a number of improvements to simplify workflow and to enhance the physician experience,” said Alexandre Chau, CEO of Endo Tools Therapeutics. “We are excited that the new system is making it easier for physicians to adopt and integrate our device into their practice.”

Early procedural experience with the next generation EZFuse system demonstrates significantly faster suturing time, with a reduction of total procedure time up to 50%, enabling physicians to complete procedures more efficiently without changing their established approach.

The suture’s single-movement mechanism eliminates unnecessary steps, creating a more streamlined workflow. The intuitive design reduces staff and operational burden as well as minimizes user fatigue, helping clinical teams perform procedures with greater ease and predictability. EZFuse suture reduces complexity across the care setting, allowing hospitals and ambulatory surgery centers to optimize resource utilization, improve scheduling flexibility, and expand overall procedural capacity, ultimately leading to improved patient care.

Denis Gestin, Chairman of the Board at Endo Tools Therapeutics, added: “ETT has always been focused on pushing the boundaries of what’s possible in endoscopic innovation. With the FDA clearance of the next generation endomina® EZFuse system, we are reinforcing our commitment to make advanced endoscopic procedures faster, simpler, and more accessible to physicians while improving efficiencies for hospitals and ambulatory centers. This milestone positions the company for accelerated growth and physician adoption in the U.S.”

The company will begin commercialization of the endomina® EZFuse system immediately in the U.S., with plans to broaden availability in key markets worldwide.

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Sunnyvale, California-based Prodeon designed Urocross as a novel, non-permanent implant technology for treating lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

Related: KORU Medical Systems announces EU MDR Certification

It marks the latest device of this kind to pick up an FDA nod related to BPH. ProVerum and Zenflow announced FDA approvals for their implant-based technologies that treat BPH in December 2025. In January of this year, Butterfly Medical also said it completed the final 12-month follow-up for all patients in a study of its prostatic retraction device for BPH. Meanwhile, last week, robotic technology developer Procept launched its BPH-treating system internationally.

Prodeon designed Urocross for procedures that utilize commercially available cystoscopes. They place a non-permanent, nitinol implant designed to remodel the obstructed prostatic tissue. The implant is then retrieved within six months. Urocross requires no permanent placement and avoids damage to prostatic tissue, preserving future diagnostic and therapeutic options.

The company supported its 510(k) clearance with data demonstrating sustained improvements in urinary symptoms, quality of life and urinary flow after Urocross retrieval. Findings also included no negative impact on sexual function.

Thomas Palermo, President of Prodeon Medical, said:

“The FDA clearance of Urocross technology represents an important milestone for Prodeon and reflects our commitment to advancing therapies that balance durable symptom relief with patient and surgeon preferences. Unlike existing minimally invasive therapies that rely on permanent implants or irreversible tissue ablation, Prodeon Medical introduces a new category of non-permanent, retrievable intervention for BPH, designed to remodel obstructive tissue while leaving no permanent foreign material behind. We plan to initiate a controlled US commercial release of the Urocross system later this year, and are excited to bring this transformative technology to market, offering a solution that is designed to prioritize clinical efficacy, patient quality of life, and minimize future risks.”

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