Depression treatment still isn’t “once and done,” but the time needed to reduce symptoms continues to drop for patients using electromagnetic stimulation. Brainsway Ltd.’s Theta Burst brings treatment times down to just three minutes with its FDA 510(k) clearance. Read More
The FDA has granted de novo authorization to Neurolutions Inc. for its Ipsihand upper extremity rehabilitation system. The first-of-its kind device leverages robotics and brain-computer interface (BCI) technology to facilitate muscle training in patients with upper limb weakness or immobility following a stroke. Read More
The Medical Device Innovation Consortium (MDIC) has been hard at work on the Make CAPA Cool program in an effort to beef up device makers’ corrective and preventive action (CAPA) programs. Kathryn Merrill, regulatory program director for Dublin-based Medtronic plc, said on an April 26 webinar that participants in the program have shaved CAPA times from 381 days to as few as 63 days, an improvement that industry hopes will ward off warning letters and product quality issues. Read More
PERTH, Australia – Advanced Human Imaging Ltd. (AHI) has created an algorithm that allows users to take a few quick scans on a smartphone to create a human avatar of themselves that can calculate risk for certain diseases and help diagnose conditions earlier, while also saving money. The Perth-based company is attracting a lot of attention, announcing three deals in the last week. The imaging technology has a myriad of uses from providing digital health scans to personal training to diagnosing skin cancers. Read More
A study led by Chinese radiologists at Peking University in Beijing has shown that positron emission tomography imaging of intercellular adhesion molecule-1 (ICAM-1) expression is a predictor for the abscopal effect, whereby nonirradiated cancers respond to radiotherapy. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angle, Biotrace Medical, Bluegrass Vascular Technologies, Livanova. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainsway, Lucira Health, Neurolutions, Phoenix Cardiac, Speedx. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: PTAB rejects 3Shape’s attempt to invalidate claims for Align patent. Read More
Keeping you up to date on recent developments in cardiology, including: Fibroblast growth factor a marker for left ventricular hypertrophy in dialysis patients; Consortium updates endpoints for aortic valve studies; ‘Reclip,’ surgery square off for patients with failed mitral valve repair. Read More
