Small Biz Bill A Big Win For Medtech Innovation: Bipartisan Legislation Awaits President’s Signature
The US Congress overwhelmingly passed legislation reauthorizing federal programs essential to smaller medtech firms in need of funding. AdvaMed says the bill is critical for medtech innovation.
Cognito Therapeutics has revealed data from its OVERTURE feasibility study backing up the ability of its non-invasive Spectris headset to treat Alzheimer’s via the stimulation of gamma oscillations. The company is hoping to launch the device in 2027
The FDA approved JenaValve’s Trilogy HeartValve for treating severe aortic regurgitation, marking it as the first TAVR device for this condition in the US. The approval, which followed promising clinical results, is significant for patients with limited options due to high surgical risks.
The global medical device market reached $623.37 billion in 2026 and should exceed $1.08 trillion by 2035. Despite this explosive growth, the journey from research and development to commercialization remains fraught with regulatory complexities, evolving market dynamics, and technical disruptions.
Vitestro raised an oversubscribed $70M Series B to scale its autonomous blood-drawing system across the Netherlands and expand into Europe. The CE-marked robot has been tested in more than 10,000 patients, and the company is pursuing FDA clearance to enter the US market.
Cognito Therapeutics closed a new funding round to advance its Alzheimer’s headset toward FDA De Novo submission and planned 2027 launch while expanding its Brain Health Collaboratory to support adoption, reimbursement innovation, and pipeline growth.
Real-world evidence (RWE) is increasingly significant in medical device submissions, with FDA guidance evolving to embrace RWE benchmarks. The National Evaluation System for Health Technology (NEST) partners with firms to streamline RWE use, enhancing regulatory processes.
New Precision IO Group CEO Kurt Azarbarzin outlines the near-term strategy for Quantum Surgical’s robotic-assisted ablation platform and NeuWave Medical’s microwave technology. Quantum recently acquired NeuWave, but the companies will continue to operate independently.
NextGate Partner’s Jay Byun gives a mixed review of South Korea’s recent biopharma policy measures, saying providing government support to all cycles of R&D may lower efficiency.
US FDA staff discussed a newly in effect guidance document on the use of real-world evidence in medical device submissions in a recent webinar. The new guidance broadens the set of data sources the agency will accept, while also clarifying the FDA’s expectations for sponsors using RWE.
California-based startup Esperto Medical hopes its ultrasound-based acoustic approach to measuring arterial shape and resonant frequencies will provide truly accurate, cuffless blood pressure monitoring.
Novocure’s Optune Pax is a wearable non-invasive device that uses electrical fields to disrupt the growth of cancer cells. A pivotal trial showed longer survival in patients who used the device than in those treated with chemotherapy alone.
INBRAIN unveiled a bidirectional "rice-sized" BCI chip partnership, Merck commercialization progress and new speech-decoding trial in France as it advances its graphene-based cortical interface toward commercialization, pending regulatory clearance.
Medtech Insight was invited to moderate a panel discussion with leading experts in neuroscience and AI during INBRAIN’s five-year anniversary in Barcelona, Spain. Panelists discussed the promises, perils in BCI development, neuroethics and outlook.
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 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.
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.
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.
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.
The FDA’s revised guidance emphasizes biological sex in clinical trials, removing references to gender and health equity considerations.