Reports of unusually high death rates for COVID-19 patients on ventilators have raised alarms, and some doctors are looking to reduce reliance on the breathing machines when possible. To advance that goal, Lungpacer Medical Inc., of Vancouver, British Columbia, has obtained an emergency use authorization (EUA) from the U.S. FDA for its Lungpacer diaphragmatic pacing therapy system (DPTS) for immediate use in ventilator patients at high risk of weaning failure, including patients with the novel coronavirus.

PARIS – Braintale SAS, of Paris, has gained CE mark approval for Brainquant. This software platform, which uses DICOM radiology imaging, enables diffusion MRI scans to be processed as part of managing patients in a coma following brain injury.

Portland, Ore.-based startup Viscardia Inc. has received breakthrough device designation from the FDA for its implantable Visone system to treat moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony. The minimally invasive implant works by stimulating a specific portion of the diaphragm.

The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.