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.

EIT Innovation Program Delivers A KIC-Start For EU Medtech Ventures

 
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EIT Health has helped 3,000 start-ups and SMEs scale across Europe and supported over 120 innovations to launch. Inspired by the US MIT, the EIT Health program is on a mission to raise awareness of its value to healthtech innovators as it embarks on new methods of funding its own activities.

perspectives 2026

Medtech 2026: Collaboration, Coverage Improvements Top Industry Wish Lists

 

Wishes for 2026 from our medtech experts focused on value-based care, faster reimbursements, and better collaboration. Key ideas included enhancing patient engagement, reducing waste, and aligning coverage policies to improve health outcomes and innovation.

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.


Volunteer State Partnership Could Mark A ‘New Day’ For Fighting Colorectal Cancer

 

A pair of diagnostic developers backed with venture capital have teamed up with the University of Tennessee to fight colorectal cancer. The collaboration seeks to advance next generation testing to catch one of the deadliest cancers in its earliest stages.

US FDA’s Updated Clinical Trial Guidance Cuts Gender Language

 
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The FDA’s revised guidance emphasizes biological sex in clinical trials, removing references to gender and health equity considerations.

ces 2026

Withings Partners With Abbott To Integrate Lingo OTC Glucose Monitoring Data

 
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Withings announced at CES that its health monitoring app will integrate data from Abbott’s OTC CGM Lingo starting in Q1.

FDA Announces ‘Common-Sense’ Reform, Expands RWE Use In Medical Device Reviews

 

The US FDA has made incorporating real-world evidence into medical device decisions a lot easier. The agency now says it will accept RWE without requiring it to contain identifiable individual patient data, making more of it available. Many stakeholders welcomed the change.


perspectives 2026

Medtech Outlook 2026: AI Integration Deepens As M&A Fuels Growth

 
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Medtech leaders expect faster change in 2026 as AI integration speeds up across all business aspects, according to a Deloitte survey of medtech execs that also predicted M&A activity will remain strong in 2026. While optimism is high, uncertainties remain.

interview

GLP-1 Sales and Fails Could Actually Inflate Gastric Balloon Market

 

Shantanu Gaur, CEO of Allurion Technologies, a company that has developed a swallowable gastric balloon, believes that GLP-1 sales could indirectly lead to increased demand for medical device-based bariatric procedures, especially as patients seek alternatives to drug side effects and weight regain.

Subsense Raises $10M To Advance Nanoparticle-Based Brain-Computer Interface Approach

 
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Neurotech start-up Subsense raised another $10m, bringing its total seed funding to $27m. The proceeds will be used primarily to accelerate and enhance the company’s pre-clinical research program.

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.


Aerogen’s Vibrating Nebulizer Could Be Breakthrough For Premature Infants

 
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Aerogen, which is Ireland’s largest native medical technology firm, is in clinical trials for Aerofact, a nebulizer aimed at aiding premature infants' breathing. The technology promises easier administration of surfactant, with potential commercial rollout projected in three to four years, if succes

Medtech’s Global Future Puts AI In The Driver’s Seat

 
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The rise and fall of US tariffs and the chill headwind from China’s state procurement policies have blown onto medtech’s radar. But how to monetize AI is the dominant concern up and down the industry.

Galway Medtech Incubators Nurture Next-Gen Innovators

 
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Start-up medtech firms in the west of Ireland can benefit from incubator programs at two of the region’s universities, which support innovators across the medical device and digital health industries from concept to multi-employee businesses.

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.


ARPA-H Launches Mental Health Initiative Under New Director

 
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US healthcare innovation agency ARPA-H has announced a $100m initiative focused on building up the evidence base for fast-acting mental health treatments such as neuromodulation and digital therapeutics. The project is the first major initiative to be led by new ARPA-H director Alicia Jackson.

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.

Getting Comfortable With The Black Box: Explainable AI Techniques Build Trust

 

A subfield of AI aims to explain why complex models make predictions, which will increase their interpretability and auditing ability, AI researcher Su-In Lee said during a National Academies of Sciences workshop.

Abbott’s $21Bn Buyout Of Exact Sciences Paves Way To Fast-Growing Cancer Screening Market

 
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Abbott will acquire Exact Sciences for $21bn, which marks the largest such deal ever in the diagnostics space. The deal will allow Abbott to enter the fast-growing $60bn US cancer screening market.