The FDA granted breakthrough device designation status to Neuropace Inc.'s responsive neurostimulation (RNS) system for idiopathic generalized epilepsy, a subtype that represents about one-third of all epilepsies. The news closely follows the company’s March 24, 2021, SEC filing to raise $75 million in an initial public offering on the Nasdaq.
The FDA has accepted Eyenovia Inc.’s new drug application (NDA) for Mydcombi, a fixed combination pupil dilation agent, with a PDUFA date of Oct. 28, 2021.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dialco Medical, Neuropace, Oxehealth, Premia Spine.
The FDA authorized marketing of the Portable Neuromodulation Stimulator (Pons) for short-term treatment of gait issues arising from mild to moderate symptoms associated with multiple sclerosis (MS) through its de novo pathway. Helius Medical Inc., a subsidiary of Helius Medical Technologies Inc., makes the non-implantable neuromuscular tongue stimulator.
Teleradiology company Nines Inc. won 510(k) clearance from the FDA for Ninesmeasure, an artificial intelligence (AI)-powered tool for measuring lung nodules. The Palo Alto, Calif.-based company says the new tool can help speed the diagnosis of certain respiratory diseases, resulting in better patient outcomes.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, other stent graft products in line for FDA panel safety probe; New conditions imposed on vaccine authorization; MRNA vaccine efficacy holds in real world; STIs on the rise in U.S.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Binx Health, Gold Standard Diagnostics, Nines.
The latest salvo in the debate over patents protecting COVID-19-related drugs, devices and vaccines came this week from U.S. industry organizations, including Advamed, the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America.
The FDA approved the world's first non-surgical heart valve to treat severe pulmonary valve regurgitation, which often affects individuals with congenital heart disease. Medtronic plc’s Harmony transcatheter pulmonary valve system (TPV) improves blood flow to the lungs without open-heart surgery. The device could extend the time before an individual born with heart disease needs open-heart surgery and the total number of such surgeries they have to endure over their lifetime.
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