Surgical Procedures

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.

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.

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.

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.

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.

After receiving US FDA clearance and reporting first successful use at Mayo Clinic, the Silicon Valley start-up plans to partner with leading centers to transform needle-based procedures with its robotic system starting with urology, then expand into other specialties, the CEO said.

SafeHeal has secured an additional €10m for its Colovac device, bringing its total funding to €97.5m. Led by Asabys Partners, this funding offers both economic and clinical benefits, potentially reducing costs and complications associated with temporary stomas.

Microbot wins FDA nod for Liberty, Medtronic’s Hugo showed positive results in hernia repair in clinical studies, Obvius Robotics reports first human procedure with CERTA, Ronovo closes a $67m financing round with JJDC, and Quantum expands Epione CE marking to bone tumors.

Abbott’s Navitor TAVR system is now CE-marked for low to intermediate risk patients, based on positive data from the Vintage trial. The EACTS guidelines for TAVR lowered the recommended age for patients with severe aortic stenosis to 70 years and older, which opens up treatment for younger patients.

Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.

The US FDA has provided an update on its breakthrough devices program, now 10 years running. Cardiac, orthopedic, and neurological devices have received the most designations, while only one has been awarded to an obstetrics/gynecology product.

Terumo will acquire OrganOx for about $1.5bn, adding the only FDA-cleared liver normothermic perfusion device to its portfolio. Analysts don’t expect the buyout to have a significant impact on competition, but the deal marks a strategic shift for Terumo into transplant medicine.