Watchman FLX, Boston Scientific’s left atrial appendage closure (LAAC) device, reduces the risk of thromboembolism from the LAA in patients with non-valvular AFib. The device aims to reduce stroke risk in such patients who need an alternative to oral anticoagulation therapy. The next-generation FLX devices feature a polymer coating, visualization markers and a broader size matrix. The company says this design helps to treat a wider range of patients.

Related: iPerf enrolls first patient in study of dual-flow femoral artery cannula

CHAMPION-AF compared Watchman FLX to non-vitamin K antagonist oral anticoagulants (NOACs) as a first-line option for stroke risk reduction. It evaluated the system in a broad population of patients with non-valvular AFib. The study met all primary and secondary safety and efficacy endpoints.

Investigators shared findings at the American College of Cardiology’s Annual Scientific Session & Expo (ACC 2026) in New Orleans. They simultaneously published findings in The New England Journal of Medicine.

According to Boston Scientific, AFib increases stroke risk by five times compared to normal heart rhythms. In patients with NVAF, more than 90% of heart-related blood clots form in the LAA, the company says. It designed Watchman to permanently close off the LAA in a single procedure.

CHAMPION-AF enrolled 3,000 patients with NVAF who were suitable for oral anticoagulation therapy across a broad spectrum of stroke and bleeding risk. It took place across 141 sites in the U.S., Canada, Europe, Japan and Australia.

At 36 months, the study met its primary safety endpoint, as Watchman FLX proved statistically superior to NOACs. Investigators saw 10.9% non-procedural major and clinically relevant non-major bleeding in the Watchman FLX group. This compared to 19% in the NOAC group, marking a 45% relative reduction in non-procedural bleeding risk.

The secondary safety endpoint positioned Watchman FLX as statistically non-inferior to NOACs at 36 months for procedural and non-procedural major bleeding (5.9% vs. 6.4%). A secondary combined safety and efficacy endpoint highlighted a net clinical benefit. Watchman FLX demonstrated superiority to NOACs in cardiovascular death, stroke, systemic embolism and non-procedural major bleeding and clinically relevant non-major bleeding.

Boston Scientific reported that the study met its primary efficacy endpoint, defined as occurrence of stroke, cardiovascular or unexplained death or systemic embolism. Watchman FLX achieved statistical non-inferiority compared to NOACs (5.7% vs. 4.8%).

The company said the study represents the largest trial comparing an LAAC device to NOACs for patients with NVAF to date. It saw a 99% procedural success rate as well. Boston Scientific plans to continue the trial through five years with additional primary and secondary endpoints.

Boston Scientific Chief Medical Officer, Atrial Fibrillation Solutions, Dr. Brad Sutton, said:

“These positive data, which have the potential to support updated clinical guidelines globally, will be used in our submission to expand the indication and coverage for the well-established Watchman platform as a first-line stroke risk reduction option, providing physicians with more choices in care for a wider range of patients who have atrial fibrillation. Today, 40% of patients with AF who are prescribed blood thinners for stroke risk reduction are not taking their medications consistently, significantly increasing their risk of stroke. The CHAMPION-AF data add to Boston Scientific’s robust body of clinical evidence supporting the Watchman device as a one-time implant that helps provide stroke risk protection over a patient’s lifetime.”

Dr. Martin Leon, study co-chair and Mallah Family professor of cardiology, chief innovation officer and director, Cardiovascular Data Science Center, Columbia University Medical Center, said:

“The success of the landmark CHAMPION-AF trial represents a meaningful milestone that will undoubtedly transform the treatment approach to stroke risk reduction in a broader population of patients who historically have needed to rely on medication. These results should give clinicians confidence in the potential of the Watchman FLX device to become a first-line treatment option for reducing the risk of stroke for a rapidly growing number of patients with AF.”

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iPerf said its device could reduce the severe complications associated with extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass (CPB) cannulas. During surgery or before treatment, ECMO and CPB support devices temporarily take over heart function and blood oxygenation. They aim to maintain organ perfusion.

Related: Providence Medical enrols first patients in CORUS-LX system trial

During ECMO and CPB, a cannula inserted into the femoral artery directs blood to the upper body, where vital organs reside. But, obstruction of the artery at the point of insertion often causes lower limb ischemia, iPerf says. It designed its device to enable 90% of blood to flow directly to the upper body and vital organs. The remaining 10% goes to the cannulated lower limb. iPerf’s dual-flow device also maintains secondary blood perusion in the leg.

The device could provide use in cardiac failure associated with myocardial infarction, aggravation of a cardiac pathology, major cardiothoracic surgery or even as part of minimally invasive cardiac surgery.

“Our device has great potential and is likely to become the gold standard for extracorporeal circulation. This first clinical study marks a major step for iPerf, after successfully overcoming the riskiest stages of development,” said Maya Bertron, iPerf CEO. “We are working on a Series A funding round and simultaneously looking at establishing industrial partnerships with different key players. We are convinced that the results of this trial will generate strong interest from practitioners, investors and international medical technology companies.”

iPerf recruited its first treated patient as part of a trial conducted at the Jacques Cartier Private Hospital in Massy, France. The patient recieved the device as part of a minimally invasive surgical aortic valve replacement (SAVR) by mini-sternotomy with peripheral CPB.

Now, the company plans to conduct its approved first-in-human trial of 15 patients receiving cardiopulmonary support for less than six hours. It aims to look at the patented device’s safety and the quality of lower limb perfusion.

In 2027, the company plans to conduct a second clinical study aimed specifically at ECMO. It plans to use the device during specific procedures associated with a heightened risk of ischemic complications. The company also intends for the cannula to integrate an innovative anti-thrombogenic function.

“It is important to sustain R&D investment in new surgical devices in France,” said Dr. Fabien Doguet, cardiovascular and thoracic surgeon, principal investigator of the study. “Starting out with an everyday problem and coming up with innovative solutions is the best way to advance our specialist fields. iPerf subscribes to this mindset and we are proud to contribute.”

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The multi-centre trial will include patients indicated for two-level interbody fusion with supplemental percutaneous pedicle screw fixation and posterior fusion.

Related: Senseonics reports sustained year-long CGM implant outcomes

They will be randomised to receive posterior fusion using either the CORUS-LX system or the standard posterior fusion method of the surgeon.

Dr Kade Huntsman of Huntsman Spinal Clinic in Utah, US, was the first to treat an enrolled subject with the study device, using a circumferential fusion approach.

This method integrates lumbar interbody fusion with percutaneous pedicle screws and the CORUS-LX system for fusion bed preparation and additional posterior stabilisation.

Drs Mohsin Fidai and Vivek Mohan joined Dr Huntsman as early-enrolling investigators in the study, which will follow subjects through 2027.

The study aims to replicate the rigorous clinical validation process seen in Providence’s prior FUSE study.

The study showed that incorporating CORUS PCSS with anterior cervical fusion yielded superior composite fusion rates compared to anterior fusion alone.

Providence Medical Technology’s chief product officer Scott Lynch said: “The FUSE study was a turning point for cervical spine surgery because it clearly demonstrated that tissue-sparing, supplemental posterior fixation improves patient outcomes for three-level patients.

“We believe this new trial will demonstrate that the CORUS-LX system provides similar biological and mechanical advantages for the lumbar spine.”

The company designed the RCT as a statistical superiority trial, comparing a treatment arm consisting of CORUS-LX plus interbody fusion and pedicle screws against interbody fusion and pedicle screws alone.

The primary endpoint of the trial is to show superior 12-month composite fusion rates while patient-reported outcomes and return-to-work data will be collected through 24 months.

Additionally, the clinical trial incorporates surgical navigation systems from Globus Medical and Medtronic to enable high-precision placement of posterior implants using a tissue-sparing approach.

The CORUS-LX system addresses limitations in both decortication and bone graft delivery that can occur with percutaneous screw fixation alone.

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The Perceval Plus Lancelot valve introduces a next-generation manufacturing process intended to enhance valve performance and durability. It features precision laser-cut bovine pericardial leaflets designed to enhance hemodynamics and improve the accuracy and consistency of the valve’s structure.

Related: Stryker launches next-gen syndesmotic fixation device for ankle stabilization

The new Lancelot technology uses a CO2 infrared laser to cut through bovine pericardium and pre-sets the sutures. The technology is designed to improve the reproducibility of the sewing process. Lancelot integrates a zero-pressure shaping process engineered to preserve tissue integrity and boost the mechanical properties and stability of the tissue, which Corcym expects to contribute to consistent reproducibility and enhanced durability of the valve.

“At Corcym, innovation begins and ends with the patient,” said Corcym CEO Christian Mazzi. “The first U.S. implantation of our Perceval Plus Lancelot valve reflects our commitment to advancing surgical technologies that support cardiac surgeons and improve outcomes for patients with structural heart disease.”

The first U.S. implant using the new valve technology was performed in September 2025, and the patient has recovered and returned to daily activities, Corcym said.

The valve expands on Corcym’s established Perceval platform and the company’s overall surgical heart valve solutions portfolio.

Corcym’s Perceval Plus valves were designed around a superelastic nitinol stent that self-expands in place, eliminating the need to knot sutures and ensuring optimal valve sealing. The stent reduces the stress transferred to the leaflets and allows the valve to follow the physiological movement of the aortic root during the cardiac cycle, mimicking the native valve.
Perceval Plus valves made with the new Lancelot technology, like the one the patient received, include the precision laser-cut bovine leaflets.

“The introduction of next-generation sutureless valve technology represents an important step forward in surgical options for patients with aortic valve disease,” said Chief of Cardiac Surgery at CHI Health and proctor for the procedure, Dr. Robert Gallegos. “Innovations like this can help surgeons perform procedures efficiently while supporting strong valve performance and long-term outcomes for patients.”

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Real-world evidence demonstrated the long-term performance and positive impact of the world’s first year-long continuous glucose monitor (CGM). The company shared findings at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Barcelona.

Related: Arsenal Medical announces first patient treated with ResQFoam

Eversense 365, an implantable system, rests under the skin for the duration of a year. Users can change its external, silicone-based adhesive daily with almost no skin reactions.

Senseonics launched Eversense 365 with its global distribution partner, Ascensia Diabetes Care, in October 2024. It has since taken over full commercial activity for the technology. The system also received clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems. Senseonics launched its system with the Sequel Med Tech twiist pump earlier this year.

In the study shared at ATTD, Senseonics said its CGM delivered strong patient adherence, glucometrics and hypoglycemic outcomes. It also delivered comparable adherence and outcomes between the first and second six-month period. This indicated high accuracy and performance from a single sensor implant over an entire year.

“The promise of a year-long CGM has now been demonstrated in the real world,” said Dr. Francine Kaufman, chief medical officer at Senseonics. “Since Eversense 365 was launched in the U.S., we have consistently heard positive feedback about the system and its impact from both patients and their healthcare providers. Today, we have presented real-world evidence that further validates our belief in this technology and what we are hearing from the diabetes community. The data demonstrate that Eversense 365 can perform exceptionally well and consistently across its entire lifespan, with strong adherence supporting a full year of positive glycemic outcomes with just one sensor.”

A look at the outcomes shared by Senseonics

Strong adherence and positive outcomes

Senseonics’ study evaluated the first 5,059 Eversense 365 sensors used by U.S. patients on open-loop insulin regimens.

Patients using the CGM had an average transmitter wear time of 93.8%, delivering comparable results over the two six-month periods. Investigators observed a mean glucose management indicator (GMI) of 7.14% and a mean time in range (TIR) of 66%. The company said this demonstrated effective glycemic control, as GMI provides an estimated A1C measurement using only CGM data. A lower value indicates better management and reduced health risks.

More than 75% of Eversense 365 users achieved hypoglycemic targets, reinforcing the system’s accuracy in low glucose ranges. In these ranges, errors can have the greatest impact on patient safety and treatment decisions, Senseonics says.

Benefits across age groups

Senseonics also shared an analysis by age, demonstrating positive glucometrics from Eversense 365 users across all age groups.

Glycemic outcomes improved with increasing age, the company said. The population greater than 65 years old achieved a mean GMI of 6.99% and a mean TIR of over 70%, with more than 85% achieving hypoglycemic targets. Investigators observed this trend with adherence, too, with over 95% average wear time in that age group.

Senseonics said that findings suggest that, while all age groups can benefit from its CGM, there may be particular benefits and positive outcomes in older populations.

Additionally, the analysis suggested that Eversense 365 could provide specific benefits to young adults (aged 18-25) who typically have poorer glycemic control. This group had a mean GMI of 7.3% with a mean wear time over 90%.

Early analysis of automated insulin delivery combination

Senseonics also shared real-world data from the first (approximately) 120 people using Eversense 365 and twiist two weeks after the full commercial rollout of the integrated offering. Users evaluated used the combined system for more than seven days.

The company saw “extremely encouraging” glucose outcomes, with a mean GMI of 6.79%, mean TIR of 77% and time in hypoglycemia of 2.7%. All figures met international consensus targets.

Senseonics said that initial data suggests an early, but positive clinical impact from the combined sensor and pump. The company plans to share a longer-term real-world analysis later this year.

“We are proud to present these data at ATTD, which is always a fantastic opportunity to connect with the diabetes ecosystem and discuss the latest developments in technology and care,” said Brian Hansen, chief commercial officer at Senseonics. The meeting is particularly timely for us this year following the recent CE mark approval and upcoming launch of Eversense 365 in select European markets. We are gaining momentum commercially in the U.S. and look forward to bringing the benefits of this unique, implantable CGM to new patients and geographies.”

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Related: TECLens begins first-in-human trial for qCXL vision correction technology

ResQFoam is an investigational trauma intervention designed to function like a human “fix-a-flat.” When injected into the abdominal cavity, it rapidly expands to apply internal pressure helping slow bleeding in patients with life-threatening injuries. This buys critical time for transport to surgery, where the foam is removed, allowing surgeons to address the underlying injury. In extensive preclinical studies, ResQFoam demonstrated strong safety and rapid hemostasis across multiple injury types, laying the foundation for its clinical evaluation. The REVIVE trial (Reducing Exsanguination Via In-Vivo Expandable Foam) is assessing ResQFoam’s safety and effectiveness for treating life-threatening abdominal bleeding at Level 1 trauma centers under an investigational device exemption approved by the FDA.

“Critically injured patients with uncontrolled abdominal bleeding face a survival rate of just 50%, even if they rapidly reach surgery at level 1 trauma centers. Every minute counts,” said Preston Hewgley, M.D., Trauma Surgeon and Principal Investigator at UAB. “In this first REVIVE case, a 34-year-old involved in a motor vehicle crash arrived in severe shock, with no detectable blood pressure and a weak pulse. After ResQFoam was administered, the patient’s blood pressure and pulse improved. He survived surgery and was ultimately discharged.”

ResQFoam received initial funding from the Defense Advanced Research Projects Agency (DARPA) and subsequently the U.S. Army Medical Research and Development Command (formerly USAMRMC) to address battlefield trauma, where abdominal bleeding is the leading cause of potentially preventable death. “ResQFoam was born from battlefield necessity, but its potential extends far beyond combat, where trauma continues to be a leading cause of death in civilians and many of these cases are preventable,” said COL David King, M.D., US Army, Trauma and Acute Care Surgeon, at Massachusetts General Hospital Trauma Center and Medical Monitor for REVIVE. “This first case in the REVIVE study is consistent with our pre-clinical findings and represents an important first step toward bringing this potentially life-saving technology to patients with limited options.”

“This milestone reinforces our vision that biomaterials can overcome limitations of traditional medical devices and lead to potentially life-saving treatments,” said Upma Sharma, Ph.D., President and CEO of Arsenal Medical. “We are grateful to the clinical teams leading REVIVE and look forward to continued enrollment.”

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The qCXL platform aims to strengthen the cornea without removing tissue, marking a step forward in refractive vision correction.

Related: VESTECK announces the results for SUTURE-TIGHT Endovascular Repair Catheter

The clinical trial will assess the efficacy and safety of the proprietary CXLens system, which delivers patterned ultraviolet (UV) light to reshape the cornea while maintaining the integrity of the epithelium.

Unlike conventional surgical methods that cut or remove corneal tissue, qCXL technology creates targeted molecular bonds in specific areas of the cornea, strengthening it and resulting in reshaping to improve vision.

The system employs a customised treatment planning engine and real-time ultrasound monitoring for precision.

The ongoing study will primarily focus on patients with refractive errors, especially those affected by presbyopia, a condition impacting around two billion people worldwide.

The non-invasive, epithelium-on treatment is performed in-office, providing new flexibility for patients and physicians.

TECLens CEO Thomas Dunlap said: “This first-in-human trial represents a transformative moment not just for TECLens, but for the field of vision correction as a whole.

“We’re introducing an entirely new category in ophthalmology by bringing vision correction out of the operating room and into the exam room, without surgery.

“Our qCXL technology has the potential to expand treatment options for millions of patients as a first-line treatment for vision correction for both refractive errors and presbyopia.”

TECLens develops non-invasive quantitative corneal crosslinking technology for vision correction. Its CXLens system uses patterned UV light to reshape the cornea with continuous biomechanical control.

The company receives funding from investors, including Johnson & Johnson Innovation – JJDC, Rimonci Capital, Sunmed Capital, and Yonjin Venture.

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Related: Kandu trial highlights positive outcomes with IpsiHand BCI system

The paper will include outcomes from 14 first-in-human patients treated with SUTURE-TIGHT™ in conjunction with commercially available EVAR devices.

Key Two-Year Findings (First-in-Human Cohort, n=14)

• Document all aneurysm sac shrinkage observed across the cohort
• Sustained graft stability, no graft migration at two years
• Nitinol sutures remained securely in place
• No suture fractures
• No evidence of suture embolization
• No evidence of endoleaks

“These two-year data provide important early evidence supporting the durability of SUTURE-TIGHT™ fixation,” said Venkatesh Ramaiah MD, one of the implanting physicians in the study. “The aneurysm sac findings, regression, graft stability and no endoleaks are encouraging for patients undergoing EVAR, in this procedure long-term durability is critical.”

Addressing Long-Term EVAR Durability and aortic tissue remodeling

“Despite advances in endovascular graft engineering and design from leaders such as Medtronic, W. L. Gore & Associates, Terumo and Cook Medical, the remodeling/dilatation of the aortic tissue creates long-term durability and fixation challenges in EVAR. Loss of proximal fixation, endoleaks, graft migration, and sac expansion continue to drive surveillance and reintervention in a subset of patients.” Said Dr. Daniel Clair, Chair of the Vascular Surgery Department at Vanderbilt and the PI for VESTECK’s 100 patient clinical trial.

The SUTURE-TIGHT™ system is designed to provide circumferential nitinol suture fixation, creating secure graft-to-aortic wall apposition while preserving endovascular workflow. The proprietary nitinol suture architecture is engineered for flexibility, fatigue resistance, and long-term structural integrity.

At two years, imaging follow-up demonstrated:

• Durable apposition of the endograft to the aortic wall
• Stable device position
• No structural failure of the nitinol sutures

“These findings support our thesis that durable, distributed fixation can meaningfully enhance EVAR performance,” said VESTECK CEO, Joe Rafferty. “Importantly, we observed no suture fractures and no embolization events — these are critical safety endpoints for any permanent implantable fixation technology.”

Next Steps

Full two-year data from the first-in-human cohort will be presented in writing and at upcoming major vascular meetings.

VESTECK plans to expand the clinical experience with SUTURE-TIGHT™ conducting our FDA 510K clinical trial.

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The trial evaluated its FDA-cleared, non-invasive IpsiHand BCI system in chronic stroke survivors. It detailed outcomes from a post-market randomized controlled study evaluating the clinical performance of IpsiHand. IpsiHand received FDA clearance in 2021 as a breakthrough-designated, 510(k)-cleared device for stroke rehabilitation.

Related: CorTec announces successful second human implantation of its BCI system

Dr. Eric Leuthardt presented findings at the International Stroke Conference (ISC) 2026 in New Orleans.

Findings demonstrated that users of the IpsiHand system achieved significantly greater improvements in upper extremity motor function than those participating in a home exercise program.

IpsiHand comes out of a collaboration and subsequent merger between Kandu, a former Imperative Care spinout, and Neurolutions. The technology enables non-invasive at-home rehabilitation for stroke survivors affected by chronic motor deficits. IpsiHand accelerates motor recovery of the affected upper limb after chronic stroke.

The study compared at-home BCI-enabled therapy using IpsiHand with a conventional at-home exercise program. Patients completed assigned therapy five times per week over a 12-week period. Participants were at least six months post-stroke with persistent upper extremity hemiparesis or hemiplegia, with no upper or lower limits on baseline Upper Extremity Fugl-Meyer (UEFM) scores.

Kandu enrolled 62 total participants, stopping enrollment early for efficacy after a planned interim analysis. It featured 37 using BCI therapy and 25 in the control.

Patients who received BCI therapy showed a mean improvement of 6 points on the UEFM scale, compared to 1.5 points in the control. Investigators say the average improvement in the group exceeded the Minimal Clinically Important Difference (MCID) of 5.25. That indicates functional gains considered meaningful to patients.

More than half of the BCI patients (55.5%) achieved a clinically meaningful response, compared to 9.6% in the control.

“This data fundamentally challenges the long-standing belief that recovery after stroke permanently plateaus after the first few months,” said Leo Petrossian, CEO of Kandu, Inc. “For decades, patients living with chronic stroke have been told that what they regain early on is all they can expect. This randomized trial shows that with the right technology—delivered at home, without the burden of frequent clinic visits—meaningful recovery is still possible years after stroke.”

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The implantation follows encouraging neurological gains observed in the study’s first participant, whose rehabilitation progress has strengthened confidence in CorTec’s fully implantable platform for stroke recovery. This represents another key milestone in the joint effort to evaluate CorTec’s fully implantable closed-loop BCI platform, developed and manufactured entirely in Germany, for therapeutic applications in neurological disorders.

Related: Atraverse reports positive data for Hotwire transseptal access system

This second procedure took place in early February at Harborview Medical Center (Seattle) under an FDA Investigational Device Exemption (IDE). Led by Principal Investigator Jeffrey G. Ojemann, MD, from the University of Washington School of Medicine in Seattle and Co PI Professor Steven C. Cramer from the University of California, Los Angeles, the trial gathers initial safety data and evaluates whether direct cortical electrical stimulation can enhance upper-limb motor recovery in stroke patients. The study is funded by the National Institutes of Health (NIH).

“The procedure went smoothly, and the participant is recovering as expected,” said Dr. Martin Schuettler, CTO of CorTec. “Having supported the implantation of our BCI system on site for a second time, it is inspiring to see how seamlessly our teams at CorTec and UW Medicine work together. This kind of clinical and technical research collaboration is essential to deliver these procedures safely. With each step, we gain important insights that strengthen our confidence in the future of this technology.”

Jeffrey G. Ojemann, MD, Vice Chair and Professor of Neurological Surgery, University of Washington School of Medicine, commented: “We are very encouraged by the outcome of thissecond implantation and pleased with the participant’s steady recovery. The notable rehabilitation progress and meaningful neurological gains observed in our first study participant using CorTec’s BCI system has led us to this next phase. Each procedure helps us refine safe clinical practices for this emerging neurotechnology and explore its potential to improve outcomes for patients in the future.”

With two successful surgeries completed at Harborview Medical Center, the study will enroll further participants and continue to gather neural and behavioral data. CorTec’s implantable closed-loop BCI platform is designed to continuously record and interpret neural activity with high fidelity and deliver targeted electrical stimulation in real time. This novel approach enables highly precise and personalized neurotherapeutic interventions by enhancing neuroplasticity – the brain’s ability to reorganize neural networks – and explores whether lost functions can be relearned, potentially accelerating and improving patient rehabilitation through the integration of engineering, neurophysiology, and machine learning.

“This second implantation is a milestone for our technology and the progress of our clinical program,” said Dr. Frank Desiere, CEO of CorTec. “More importantly, it brings us closer to realizing the potential of a new class of neurotherapeutic solutions that could meaningfully improve outcomes for patients with neurological conditions and lays the groundwork for the next phase of clinical and technology development.”

CorTec will continue to share updates as the study progresses, and additional insights emerge.

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