For the second time in four years, the FDA has issued a draft guidance for cybersecurity in premarket applications, just one of several actions undertaken recently by the U.S. federal government in connection with cybersecurity.

The twos have it as the U.S. FDA’s Office of Prescription Drug Promotion, in its second untitled letter of the year, took Bausch Health Cos. Inc. to task over two promotions of its plaque psoriasis lotion, Duobrii (halobetasol propionate and tazarotene).

Israeli startup Sanolla Ltd. won U.S. FDA 510(k) clearance for its smart-infrasound stethoscope Voqx. The artificial intelligence (AI)-based device is the first stethoscope cleared by the U.S. FDA to detect infrasound and audible information to identify clinical conditions. The auscultation capabilities are designed to support early assessment of cardiopulmonary conditions.

Ossio Inc. has received FDA clearance for Ossiofiber suture anchors used to fix soft tissue to bone in the shoulder, foot and ankle. This is the most recent of clearances for the company’s intelligent bone regeneration technology which began in 2019 as a possible alternative to permanent fixation implants for the foot and ankle alone.

Merit Medical Systems Inc. received FDA 510(k) clearance for the Scout Bx delivery system, which enables the placement during stereotactic and MRI-guided biopsy of a reflector to guide breast surgery. The delivery system works with the company’s Scout reflector, a wire-free radar localization device.

The U.S. FDA has given the green light to a pelvic organ prolapse (POP) repair device developed by Misgav, Israel-based Escala Medical Ltd. The mesh-free, non-surgical repair system is designed to anchor sutures to ligaments of the pelvic floor in an incision-free procedure. Escala, which is a portfolio company of Israeli government franchised incubator Trendlines Group Ltd., believes the device will help the 1 in 5 women in the U.S. affected by POP.

Glaxosmithkline plc and Vir Biotechnology Inc.’s sotrovimab has become the latest COVID-19 antibody to be pulled from the market in the U.S., after the FDA revoked its emergency use authorization (EUA) because of the rise of the omicron BA.2 subvariant.

The Senate Health, Education, Labor and Pensions (HELP) Committee met April 5 to review the user fee agreements for the drug and device centers, but one member of the committee was quite vocal about the ever-growing volume of user fees. Sen. Richard Burr (R-N.C.) said the pace with which user fees are increasing suggests that the FDA is growing increasingly independent of Congress.

Even as many in the U.S. are looking for the end of the COVID-19 public health emergency, Health and Human Services (HHS) Secretary Xavier Becerra reinforced expectations April 5 that he will continue the emergency declaration into the summer, if not beyond. When asked during a Senate Finance Committee budget hearing if he saw the emergency ending this summer, Becerra declined to give a date, but reiterated his commitment to give stakeholders at least 60 days’ notice.