When Brain-Computer Interfaces Fail, Human Trial Participants Have Few Options

 
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In this final part of a three-part series, Medtech Insight spoke with a neuroethicist and the first person in a trial using a BCI implant for stimulating hand movement. This story explores ethical considerations that arise when projects can no longer support patients with implanted devices.

Intuitive Eyes Opportunities In Cardiac Care, Outpatient Centers

 
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The FDA has cleared Intuitive Surgical’s da Vinci 5 for some cardiac procedures, opening new opportunities for the firm. The company is also looking to expand its presence in ambulatory surgical centers, execs said during a Jan. 22 earnings call.

BioStem Expands Into Hospitals, Internal Sales Force With BioTissue Surgical Wound Care Acquisition

 
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BioStem Technologies’ buyout of BioTissue Holding’s surgical and wound-care business adds cryopreserved and sterile technologies, Cryotek and SteriTek, and a direct sales force focused on acute care settings.

Abbott Wins CE Mark For Dual-Ablation Catheter In Increasingly Competitive AFib Ablation Market

 
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Abbott’s newly CE-marked TactiFlex Duo dual-ablation catheter used for treating AFib is competing against products already introduced by Boston Scientific, J&J and Medtronic.


Multiple Injuries, Deaths Linked To Boston Scientific Axios Stent And Delivery System

 

The US FDA has issued an early alert concerning some Axios stent and delivery systems used in endoscopic drainage procedures after receiving reports of serious injuries and deaths linked to the device.

ces 2026

Among The Razzle-Dazzle, Surgical Science Quietly Pitched Simulator For Robotic Surgical Training

 
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Amid the spectacle of humanoid robots at CES 2026, Swedish medical simulation company Surgical Science opted for a quieter pitch for its suitcase-sized robotic surgery simulator aimed at taking training out of the OR.

J&J Says Ottava Represents A ‘New Category’ Of Soft Tissue Robots

 

Johnson & Johnson is seeking marketing authorization from the US FDA for its Ottava surgical robot for upper abdomen procedures. If granted, Ottava could prove stiff competition for Medtronic and Intuitive.

Stereotaxis’ MAGiC Catheter Cleared by FDA For Congenital Heart Disease, Eyes Pulse Field Use

 
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The MAGiC catheter works with Stereotaxis’ robotic magnetic navigation technology, which allows physicians to steer catheters through the heart with precision and stability.


FDA Advisory Panel Says ‘Human Factor’ Essential In Evaluating Germicidal Ultraviolet Devices

 

The US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee convened Wednesday to discuss germicidal ultraviolet (GUV) devices as a mode of disinfection, a technology that has emerged since the COVID-19 pandemic.

Xeltis Raises €50M To Advance Tissue-Regenerating Dialysis Access As CMS Opens Door To New Options

 
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Xeltis secured €50m to scale and market its aXess vascular access graft, a bioresorbable scaffold that transforms into a patient’s own living vessel. With EU regulatory review underway and US trials advancing, Xeltis sees new US Medicare rules as a major opening for alternative treatments.

Olympus Hits Another Endoscope Snag, Updates Instructions For PolyLoop After 113 Serious Injuries

 

The US FDA says Olympus has updated its instructions for a device used in many endoscopic procedures after reports of serious injuries. The class I recall follows the FDA blocking imports of other scoping devices from the Japanese firm earlier this year.

Medtronic’s Hugo RAS Gets FDA Nod For Urologic Procedures, But Intuitive Still Leads, Analyst Says

 
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Medtronic won FDA clearance for its Hugo surgical robot for urologic procedures, which Wiliam Blair analyst expects will draw interest from physicians. But he also says that Intuitive Surgical will remain the clear dominant player.


Paradromics Joins Neurotech Race With FDA Nod To Test BCI For Restoring Speech

 
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Paradromics won FDA clearance to test its Connexus BCI in two people with severe speech impairment. The 2026 trial will assess whether the device can decode speech in real time.

Precise Bio Achieves Historic First 3D-Bioprinted Corneal Implant In Human, Part Of Early Trial

 
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Medtech Insight spoke with Rambam Medical Center’s Michael Mimouni, who implanted the first 3D-bioprinted corneal graft in a human patient, about his hopes for Precise Bio’s approach. The patient is part of a Phase I trial evaluating PB-001 in patients with corneal edema.

Digital Health Roundup: BCIs Surge Ahead, Oura Eyes BP Clearance, AI Faces New Scrutiny

Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.

BCI Maker INBRAIN Inks Deal With Microsoft To Explore Agentic AI Use For Monitoring Patients

 
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INBRAIN teamed up with Microsoft to apply agentic AI to analyze real-time brain data and eventually recommend programming like a “mini-neurologist,” said CEO Carolina Aguilar. It also seeks to enable scalable deployment of INBRAIN’s graphene-based technology and potential joined research.


Synchron Secures $200M Series D, Plans New Brain Interface With ‘Potentially More Applications’

 
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Synchron raised $200m in series D funding to support pivotal trials in 2026 as well as commercialization of its Stentrode BCI. It also announced plans for a next-gen high-channel whole-brain interface and a new engineering hub in San Diego.

A Trillion On The Table. Addressing Disparities In Women’s Health Isn’t Just Right. It’s Smart.

 

Advocates spanning the spectrum of women’s health met in Manhattan to discuss the gender disparities that remain in healthcare and how public policy can correct them and the enormous ROI investors in women’s health can potentially reap.

Intuitive Surgical Leverages da Vinci 5 Upgrade Cycle To Expand Portfolio With Refurbished Xi

 
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With redeployment of older Xi systems creating new cost tier options for hospitals, Intuitive added 340 employees last quarter across commercial, engineering and manufacturing. Next year, it plans to shift to a direct sales model in Italy, Spain and Portugal as part of a regional realignment.

Brain Cancer Treatment From GT Medical Could Redefine Standard Of Care

 

GT Medical says interim results from a clinical trial studying an innovative surgical procedure to treat brain tumors show promise for patients with newly diagnosed operable brain metastases.