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.
PARIS – Barely one year after its formation, startup company Quantiq SAS has just closed an $825,000 seed round, to develop its contactless medical diagnostics technology. French business angels from the medical, artificial intelligence and fintech worlds participated in this initial fundraising.
Med-tech M&A continued an upward trend through March, with 30% more completed in 2021 compared with this point last year. Deals, including collaborations, licensings and joint ventures, are up by 13%, although the value of those deals are trailing 2020 by 39%.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief:, Agilent Technologies, Alydia, B. Braun, Delfi Diagnostics, Infraredx, Janssen, Komodo Health, Merck, Natera, Nipro, Organon, Oscar A-Co, Premier, Takeda, Tempus, Tesis Labs.
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.
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