The Federal Trade Commission (FTC) is seeking to block Illumina Inc.’s $7.1 billion purchase of Grail Inc., claiming the deal will “diminish innovation in the U.S. market” for multicancer early detection (MCED) tests, which could be used to flag dozens of tumor types when they are still treatable. Illumina has vowed to “pursue all legal options” to complete its acquisition of Grail, arguing that it does not compete with Grail and is committed to providing “unfettered access” to its NGS technology. Read More
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. Read More
The Made in America Tax Plan President Joe Biden is proposing to pay for his $2 trillion U.S. American Jobs Plan could change the way multinational drug and device companies do business, as well as curb M&As that take advantage of global tax benefits. Read More
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. Read More
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%. Read More
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. Read More
New hires and promotions in the med-tech industry, including: Caredx, Genome Medical, Group K Diagnostics, Sera Prognostics, Zimmer Biomet Holdings. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dialco Medical, Neuropace, Oxehealth, Premia Spine. Read More
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. Read More
Keeping you up to date on recent developments in orthopedics, including: Scientists use nanotechnology to detect bone-healing stem cells; Premia reports FDA breakthrough device designation for Its Tops system; 'Break a leg' not so lucky when it leads to limb deformities. Read More
