Investigators at the University of Heidelberg have identified a previously unknown mechanism for excitotoxicity and used their insight to identify “unconventional neuroprotectant” compounds that could prevent cell death and reduce brain damage in a mouse model of stroke.

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.

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 The FDA’s October 2018 draft guidance for premarket considerations for cybersecurity in medical devices might fall into that latter category, but the FDA’s Suzanne Schwartz said the agency will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.

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.

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.

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.

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.