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