The FDA has released two draft guidances under the safety and performance-based pathway for class II devices, proving some much-needed momentum for the agency’s fiscal year 2021 guidance agenda. The two drafts address performance metrics for facet screw systems and the use of resins in dentures, thus adding substantially to the number of class device types that can be reviewed outside the usual substantial equivalence mechanism ordinarily relied upon in the 510(k) program. The FDA began implementing the safety and performance-based pathway for devices in late 2019, an approach that serves as a substitute for the abbreviated 510(k) mechanism.

Vagus nerve stimulation (VNS) researchers notched another success with FDA approval of a drug-free rehabilitation system that uses the technology to help patients who have lost mobility in their hands and arms as a result of ischemic stroke regain function. Microtransponder Inc.’s Vivistim pairs rehabilitation exercises with VNS to enhance their impact. The clinical study evaluated by the FDA for the system's approval showed that Vivistim doubled the improvement in upper extremity motor function compared to supervised rehabilitative exercises alone at six weeks and 90 days.

The FDA has issued an emergency use authorization (EUA) for Becton, Dickinson & Co.’s (BD) Veritor At-Home COVID-19 test – a rapid COVID-19 digital antigen test. The test, which is designed for home use, uses a mobile app from Los Angeles-based Scanwell Health Inc. that provides instructions on how to collect and transfer the nasal swab sample to the test stick. The smartphone camera is then used to capture, analyze and interpret results within 15 minutes. BD said it will initially be rolled out to businesses, schools and governments looking to provide a self-testing option.

Helius Medical Technologies Inc. has received an FDA breakthrough device designation for its Portable Neuromodulation Stimulator (Pons) device for temporary treatment of dynamic gait and balance deficits due to stroke.

The wave of home-use tests for the COVID-19 pandemic has amplified the question of how device makers might validate such a test, but there is also the question of how to convert a device from prescription-only (Rx-only) use to over-the-counter (OTC) status to consider. The FDA has provided an update on OTC devices, which indicates that a conversion from prescription-only use to OTC use will require usability testing and a new regulatory filing, but the update conflicts with the agency’s own policy on changes to a device undertaken only to convert the label from prescription to OTC use.

The FDA has posted an advisory regarding robotically assisted surgery (RAS) for mastectomy, but the agency also pointedly noted that it is aware of studies underway for such indications without the appropriate oversight. The FDA did not name Intuitive Surgical Inc. in the notice, but the company nonetheless responded to the FDA statement by confirming the absence of any devices thus approved or cleared. The FDA had previously issued a Feb. 28, 2019, advisory stating that the safety and efficacy of RAS devices for mastectomy and the prevention or treatment of breast cancer had not been established.

Ascendis Pharma A/S kept mum on the cost of just-approved Skytrofa (lonapegsomatropin) for pediatric growth hormone deficiency (GHD) – saying only that “premium responsible pricing” would be put in place – but Wall Street speculated freely about revenues likely due from the first-ever weekly injection treatment.

The FDA has approved Medtronic plc’s Evolut FX TAVR system for patients with symptomatic severe aortic stenosis. During Medtronic’s fiscal first quarter earnings call CEO Geoffrey Martha said the company will roll the latest generation system out in the U.S. market later this year, with a full launch planned in 2022.

Advancing efforts from PDUFA VI, the seventh iteration of the user fee agreement negotiated between the U.S. FDA and drugmakers is intended to take patient involvement in drug development to the next level, support a new wave of biologics, and provide more tools for developing therapies and cures for rare and ultra-rare diseases.