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 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.
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 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 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.
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.
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.
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 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.
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.
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.
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.
C-suite executives from Stryker, Intuitive Surgical and Fresenius passed a mainly upbeat verdict on the Indian medtech market and industry.
J&J announced the separation of its orthopedics unit into a stand-alone company. The firm as a whole expects sales growth of over 5% in 2026. Gabelli analyst Jennie Tsai foresees more consolidation in orthopedics led by Zimmer Biomet, Stryker and DePuy as well as more acquisitions.
At the MedTech Conference, the CEOs of Stryker, Hologic and Insulet said during a panel AI is now central to their business strategies, from creating new medical devices to streamlining workflows and administrative tasks. Stryker’s CEO Kevin Lobo plans a business unit focused on AI-enabled tech.
Successful implantations of a novel transcatheter mark a major step forward in treating congestion in heart failure, according to the California-based company that developed it. The procedure was part of a feasibility study evaluating the device’s safety.
The US FDA has issued a safety alert regarding an Abiomed recall of Automated Impella Controllers, the primary interface for pumps that help to reduce demand on heart’s left ventricle in heart failure patients.
Barcelona-based INBRAIN Neuroelectronics is partnering with Mayo Clinic to test whether its graphene-based cortical brain computer interface can enhance standard DBS in Parkinson’s, aiming for more precise adaptive therapy and improved gait outcomes.
The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.
Medtech Insight spoke with Sanjay Kakkar, Tensive CEO, about the firm’s breast tissue regeneration implant and its surgical benefits, including a reduced operation time of 74 minutes. He anticipates regulatory approval for Regenera in early 2027.