MedTech News
Darmiyan Receives FDA Approval for Post-Market Surveillance Study of BrainSee, the First-in-Class Clinical Test for Predicting Risk of Progression to Clinical Alzheimer’s Disease
SAN FRANCISCO, May 29, 2025 /PRNewswire/ — Darmiyan, Inc., a leading brain health technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s post-market surveillance study for BrainSee, its groundbreaking clinical prognostic tool for Alzheimer’s disease. This 7-year study aims to further validate the safety and effectiveness of BrainSee in a socio-demographically diverse patient population across the United States. The insights gained will also support pharmaceutical companies and contract research organizations (CROs) in identifying optimal candidates for next-generation Alzheimer’s clinical trials—advancing both precision and equity in patient selection.
Olympus Announces Launch of New Endoscope Drying Cabinet
CENTER VALLEY, Pa., May 29, 2025 /PRNewswire/ — Olympus Corp., a global medical technology company committed to making people’s lives healthier, safer and more fulfilling, announced today the launch of the ScopeLocker Air endoscope drying cabinet, offering a new drying option for healthcare facilities.
A nearly invisible brain-computer interface (BCI)
Georgia Tech researchers have just shared a game-changing breakthrough: a nearly invisible brain-computer interface (BCI) that fits between hair follicles and sits just beneath the skin. No bulky headgear, no conductive gel – just a wireless sensor smaller than a millimeter, picking up brain signals with 96.4% accuracy, even while walking or running.
Empatica wins CE mark for epilepsy monitor
Empatica announced today that it received CE mark approval for its EpiMonitor epilepsy monitoring solution.
Distalmotion wins FDA nod for gallbladder removal with surgical robot
Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter surgical robot in adult cholecystectomy (gallbladder removal).
Exactech Launches Advanced Shoulder Planning App for Enhanced Surgical Precision
Next-generation platform integrates 3D visualization and smart surgical tools to improve outcomes in shoulder arthroplasty
Abbott wins FDA approval for mitral valve replacement device, teeing up Edwards competition
Abbott said the Tendyne system addresses a significant unmet need, providing an option for patients ineligible for open heart surgery and whose valves cannot be successfully repaired with MitraClip.
Rationale engineering generates a compact new tool for gene therapy
Researchers redesign a compact RNA-guided enzyme from bacteria, making it an efficient editor of human DNA.