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.
Ahead of Exact Science’s $21bn dollar acquisition by Abbott, Medtech Insight spoke to the company’s chief medical officer, Tomasz Beer, to learn more about the company’s multi-cancer early detection offering, its wider portfolio of products and to hear more about the direction of the field.
Medical device companies are increasingly using AI to improve regulatory affairs strategies but face barriers such as risk aversion, regulatory clarity and data governance issues. Experts suggest a design control approach and human oversight to ensure successful AI integration.
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.
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.
A subfield of AI aims to explain why complex models make predictions, which will increase their interpretability and auditing ability, AI researcher Su-In Lee said during a National Academies of Sciences workshop.
Hallucinations are a common problem in AI and pose significant challenges to medical devices powered by the technology. A paper authored by several FDA staffers argues that focusing on how hallucinations impact patients is the best approach.
A California jury found in favor of device firm Masimo in a long-running legal battle against the tech giant. Apple has already announced plans to appeal.
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.
Neurotech start-up Subsense started proof-of-concept studies in mice hoping to show by late 2026 that its nonsurgical, nanoparticle-driven brain-computer interface can read and stimulate neural activity and treat conditions such as Parkinson’s and epilepsy.
