Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19.

Medrhythms Inc., a digital therapeutics startup based in Portland, Maine, won an FDA breakthrough device designation for its Rhythmic Auditory Stimulation (RAS) treatment platform for people with chronic walking impairments due to stroke.

San Diego startup Glysens Inc., which is developing implantable continuous glucose monitoring (ICGM) technology, closed a $15 million incremental financing. The funds will be used to support ongoing clinical trials and development of the company’s fully implanted, long-term CGM systems.

Medtronic plc, of Dublin, has gained CE-marking approval for its Minimed 780g system, a next-generation closed-loop insulin pump for people with type 1 diabetes between the ages of 7 and 80 years old. The advanced hybrid closed-loop system (AHCL) features an advanced autocorrection algorithm and Bluetooth connectivity.

Cue Health Inc. scooped up $100 million in a series C round to support the launch of its rapid molecular testing platform. The funds will be used to finalize the development and validation of the Cue Health Monitoring System and Cue Test Cartridges, as well as to scale up manufacturing operations.

Boston-based startup Cerevasc Inc. scooped up $43.9 million in a series A round that was led by Perceptive Xontogeny Venture (PXV) Fund and Aton Partners LLC. The funds are earmarked to support a first-in-human trial of the company’s Eshunt system for the treatment of hydrocephalus, as well as subsequent clinical studies to support regulatory approvals.

Minneapolis-based startup Nuvaira Inc. has received breakthrough device designation from the U.S. FDA for its Dnerva lung denervation system to reduce the risk of moderate-to-severe exacerbations of chronic obstructive pulmonary disease (COPD) in patients receiving optimal care. The bronchoscopic procedure works by disrupting pulmonary nerve input to the lung, improving symptoms and stabilizing lung function.

Toronto-based Titan Medical Inc. has inked a development and license agreement with Medtronic plc, of Dublin, to advance the development of single-port robotic-assisted surgical tools. A separate agreement gives Medtronic licensing rights to certain Titan intellectual property. The arrangement aligns with Medtronic’s goal of building its robotic-assisted surgery business and gives Titan’s financials a needed shot in the arm.