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.

Smart Meter LLC has launched its Iglucose blood glucose monitoring system for managing gestational diabetes. According to the CDC, every year, 2% to 10% of, or 700,000, pregnancies in the U.S. are affected by gestational diabetes, with incidences increasing worldwide. Usually tested around week 24 of pregnancy, gestational diabetes can cause severe complications in women including preeclampsia, hypoglycemia and babies born large for gestational age.

In a passionately worded 141-page decision, the U.S. Court of Appeals for the First Circuit said the lower court was wrong in overturning part of a jury verdict convicting former Insys Therapeutics Inc. executives of a scheme to bribe doctors to prescribe Subsys (fentanyl), which was approved only to treat breakthrough cancer pain.

Eclipse Regenesis Inc. received a National Institutes of Health fast track grant of $1.7 million to advance development of the Eclipse Xl1 system for short bowel syndrome. The spring-like Eclipse device harnesses mechanotransduction to stimulate growth of new, functional intestinal tissue. Short bowel syndrome is a devastating and rare condition that leads sufferers with too little small intestine to extract sufficient nutrients to sustain life. The grant for Menlo Park, Calif.-based Eclipse came through NIH’s small business innovation program.

The U.S. National Institutes of Health (NIH) said it has developed a novel method of sample preparation for tests for the SARS-CoV-2 virus, which could trim time and costs for diagnostic testing for COVID-19. This approach bypasses the RNA extraction step, thus eliminating the need for some supplies, and NIH said this technique is available for co-development or licensing with the private sector, giving the smart testing company access to a patent-protected technology with an existing demand already built in.

The U.S. Federal Trade Commission (FTC) is hardly alone in its antipathy toward Illumina Inc.'s acquisition of Grail Inc., and FTC attorney Susan Musser said Aug. 24 that Illumina’s dominance of the market for next-generation sequencing (NGS) is perhaps the key aspect of the FTC’s case. Musser invoked the wide number of companies that jumped into the fray to develop a vaccine for the COVID-19 pandemic as an illustration of the need to maintain competition in the multicancer testing space.

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.