With An Eye On Diversity, FDA Recognizes MedTech Color Collaborative Community

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.

BrainsWay advanced its Deep TMS platform with an FDA labeling expansion for adolescent MDD and the launch of a 200-patient alcohol use disorder trial. The company posted strong Q3 growth and is pursuing new indications and at-home neuromodulation through its Neuralief investment.

Data from Medicare patients shows no increased death risk for peripheral arterial disease patients treated with drug-coated devices, easing concerns that once led FDA to discourage use of the products. Researchers say the study could be a model for future large-scale cardiac device safety trials.

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.