With an ambitious goal of bringing 24/7 electroencephalogram (EEG) capabilities to hospitals across the country, Epitel Inc. closed a $12.5 million series A financing round that it plans to use to fund the initial pilot for commercialization of its wearable, wireless EEG platform. The Epilog platform received FDA clearance for use in hospital emergency departments and critical care units last year.

The Biden administration has posted a request for information (RFI) about the conditions necessary for the in vitro diagnostic industry to sustain testing capacity for communicable disease outbreaks, although the letter commits to no specific actions. The Advanced Medical Technology Association responded to the RFI with the recommendation that the administration quickly commit to the provision of resources as a means of ensuring that “market volatility will no longer determine test availability.”

The FDA’s device center has been eyeing an overhaul of its Quality System Regulation (QSR) for several years, and the latest development is the scheduling of a March 2 advisory committee hearing to review the proposal. The default assumption is that the agency will post the draft rule prior to the hearing, although the routine two-day window for reviewing FDA meeting materials prior to an advisory hearing might leave stakeholders with insufficient time to examine the agency’s proposal.

India’s health care industry stakeholders have been left scratching their head as authorities, who have championed self-reliance and increased supplies, provided mixed signals in recent notices.

Swiss spinal surgery company Neo Medical SA has closed a $20.6 million financing round led by Swisscom Ventures. The funds will be used for U.S. commercialization of the company’s Advise augmented reality (AR) platform for spinal surgery. The platform is due to launch this year and will complement Neo Medical’s existing implant and instrument solutions. “The funds will be used for recruitment of sales direct sales force, training and education activities in the U.S. as well as U.S. scientific and clinical activities,” Neo Medical CEO Vincent Lefauconnier told BioWorld. “In 2022, we will see some key scientific and clinical work being published showing the massive benefit for patient of the use of our unique combination of technologies.”