Neocis Inc., which developed the first U.S. FDA-cleared robotic-assisted dental surgery system, has completed a $72 million series D financing led by Dfj Growth. The funds will be used for broader commercialization and future advancements to the Yomi platform. Also participating in the series D round were Vivo Capital and existing investors Mithril Capital Management, Norwest Venture Partners, Section 32 and Fred Moll. With this latest capital infusion, Miami-based Neocis has raised a total of $120 million in financing to date. Read More
San Carlos, Calif.-based Galaxy Medical Inc., which has developed pulsed electric field (PEF) technology for the treatment of cardiac arrhythmias, revealed the first treatments in the ECLIPSE-AF study, which is evaluating the Centauri system. The trial will assess the safety and efficacy of the Centauri as the company looks forward to obtaining a CE mark. Read More
There are some U.S. FDA work items that have been hampered primarily by the COVID-19 pandemic, and some that have just proven difficult to push across the finish line. The FDA’s October 2018 draft guidance for premarket considerations for cybersecurity in medical devices might fall into that latter category, but the FDA’s Suzanne Schwartz said the agency will reissue another draft version of that guidance, which will be available sometime in early 2021. Read More
COVID-19 stalled clinical trials, halted elective surgeries, and body slammed many med-tech companies’ revenues. Despite that, an industry report released by Ernst & Young (EY) finds that the pandemic also drove some positive changes in the med-tech industry including long-neglected attention to enterprise-wide business continuity. Read More
CAJICA, Colombia – In a move to reduce bureaucratic procedures and fight backlogs, the Brazilian health care surveillance agency, Anvisa, softened its rules for the marketing authorization of class II medical devices in the Latin American country. Read More
LONDON – Industry is calling on the government to set out a plan for the safe and sustainable restart of non-COVID-19 clinical studies that were put on hold when the pandemic struck. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Instructions needed for self-sampling from nares; House Dems blast FDA decision on lab test review; DOJ take-down identifies massive telehealth fraud; Health Canada explains COVID-19 disclosures; GAO says FDA lab safety office lacks teeth. Read More
Med-tech firms raising money in public or private financings, including: Applied DNA Sciences, Aziyo Biologics, Nanostring Technologies, R3 Vascular, Spinal Elements. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Development of Additive Manufacturing, American College of Cardiology, Butterfly Network, Castle Biosciences, Cb Scientific, Curvafix, Dexcom, Eli Lilly, Fondazione Michelangelo, Fortanix, Fresenius, Intel, Isoplexis, Livongo, Mango Wellness, Microsoft, Mölab, My Cardia Thailand, Mybio, Nanovibronix, Nec Oncoimmunity, Oncocyte, Palmetto GBA Moldx, Rhythm AI, Scanwell Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Reflow Medical. Read More
Keeping you up to date on recent developments in diagnostics, including: Improving sensitivity of COVID-19 tests; Deep learning algorithm helps triage suspected COVID-19 cases; Cancer image analysis tool incorporates HER2 biomarker assay. Read More
