Device Area

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 is launching a pilot to promote access and safety to digital health devices. Developed by the agency’s device center, the pilot will evaluate a new, risk-based enforcement approach for certain types of digital devices to treat several conditions.

The French start-up has successfully implanted its ‘fishtail’ LVAD in a patient for 84 days, where it served as an effective bridge to transplant. Medtech Insight spoke to the company’s CEO, Louis de Lillers, to hear more about the company’s progress and his take on the evolving LVAD market.

Medtech funding in 2025 sees a trend of fewer, yet larger deals with total funding of $3.6bn in Q1, $2.6bn in Q2 and $2.9bn in Q3, said LSI’s Nick Talamantes. In 2026, he expects a continued investor focus on more mature firms in areas of oncology, cardiology and neurology.

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.

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.

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

The US FDA is launching a pilot to promote access and safety to digital health devices. Developed by the agency’s device center, the pilot will evaluate a new, risk-based enforcement approach for certain types of digital devices to treat several conditions.

New rule in effect Jan. 1 follows OIG call for CMS to use competitive bidding to adjust payments for continuous glucose monitors after finding that Medicare was paying above supplier costs and retail prices.

US Medicare payments for CGMs and supplies in the year to June 2023 exceeded suppliers’ acquisition costs by $377m, says new OIG report

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

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.

Freenome will combine with Perceptive Capital Solutions Corp in a SPAC deal worth $330m. The goal is to advance Freenome’s blood-based tests for early detection of cancer and, in 2026, launch its advanced colorectal cancer detection test SimpleScreen, currently under FDA review.

Pending legislation in the US House of Representatives would allow Medicare patients to benefit from some of the latest and most innovative technologies. The bipartisan bill would establish a clear pathway for reimbursement for algorithm-based healthcare services approved by the FDA.

Truvian reached a major milestone with the FDA clearance of its blood-testing benchtop but is awaiting further FDA clearances of blood panels before a full launch in the second half of 2026.

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.

Inspired by his son’s battle with cancer, Neal Piper founded Luminoah to modernize enteral feeding. Its smart, pocket-sized pump tracks nutrition in real time to prevent malnutrition and improve quality of life for patients and caregivers.

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.

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.

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 has approved Flow Neuroscience’s at-home brain stimulation device for the treatment of depression, ending a frustrating wait for the Swedish firm.

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.

Ceribell’s algorithm analyzes EEG data collected through a headcap equipped with sensors can identify subclinical events unnoticed without continuous monitoring.