Ultrasound companies, Caption Health Inc. and Ultromics Ltd. are linking up to jointly offer Caption’s AI software platform with Ultromics’ Echogo deep ultrasound analytics for cardiovascular disease detection.

Entities that lack experience in FDA regulation of medical devices may find the going both expensive and time consuming, but there are resources available to these players in the digital health space. Bakul Patel, director of the Digital Health Center of Excellence at the FDA’s device center, said that while he understands that reading through agency guidance is an unpleasant task, the companies that take the time to do so may find their interactions with the agency less iterative and more productive, thus speeding their path to market.

Arthrex Inc., of Naples, Fla., is well known for lobbing a legal hand grenade into the inter partes review (IPR) process for patent disputes, but the company is now drawing ink for a different legal reason. According to the U.S. Department of Justice (DoJ), Arthrex has agreed to pay $16 million to settle allegations that it engaged in kickbacks to a surgeon, payments ostensibly made to pay for assistance with device design, but which the DoJ claims were intended to induce the surgeon’s use and endorsement of Arthrex products.

The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the proposal to provide automatic Medicare coverage of FDA breakthrough devices, but the proposal may not be as dead as it once seemed.

Shares in Rewalk Robotics Ltd. are on the rise after the FDA awarded its Reboot exoskeleton device breakthrough device designation status. The wearable, battery-powered device is designed to assist individuals with lower limb disability due to stroke.

Hot off the heels of a $45 million series B financing raise, Activ Surgical Inc. has completed the first clinical trial evaluating its Activinsights augment reality (AR)-based software suite and Activsight imaging module. The safety and feasibility study, carried out with The University of Texas Health Science Center at Houston (UTHealth Houston) is the first of several trials the Boston-based company is planning in 2021.

The U.S. CMS waded into controversy with two final rules calendar year 2022, drawing fire from device makers and doctors who allege that cuts in rates for physicians will hamper beneficiary access. Software developers working in the telehealth space will find much to cheer, however, given that some telehealth services that were covered during the COVID-19 pandemic will be covered after the pandemic has passed.