The field of artificial intelligence (AI) is stretching the boundaries of conventional med-tech regulation, and several regulatory agencies are working to cut that Gordian knot. Marc Lamoureaux, director of digital health at Health Canada’s (HC) medical device directorate, said on a Sept. 21 webinar that legislation passed in 2019 gives the agency a “regulatory sandbox” in which to experiment with AI regulation, a mechanism he said may bring these algorithms to market much more rapidly than would otherwise be the case.
Visby Medical Inc. emerged from stealth mode to secure emergency use authorization (EUA) from the U.S. FDA for its Personal PCR device for detection of COVID-19 infections. It is the first FDA-authorized portable device to use the polymerase chain reaction technology for COVID-19 testing. The San Jose, Calif.-based company was known as Click Diagnostics Inc. until March 2020.
While COVID-19 is responsible for about 14% of the regulatory data collected by BioWorld in 2020 and even though numerous clinical trials have suffered delays, the pandemic does not appear to have slowed the pace of the FDA’s approval process.
The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said.
The FDA has granted Plus Therapeutics Inc. fast track designation for its lead candidate, Rhenium Nanoliposomes (RNL), for treating recurrent glioblastoma, propelling it into the sixth cohort of a phase I dose-finding trial.
B-Temia Inc.’s Keeogo mobility device is on the move in the U.S. now that it has received 510(k) clearance from the U.S. FDA. Unlike currently available exoskeletons that move for patients, the Keeogo (keep on going) Dermoskeleton system amplifies signals from patients who can initiate movement but need additional assistance.
Mallinckrodt plc’s decade-long frustration with getting approval for its vasopressin analogue selective for V1 receptors, terlipressin, for use in hepatorenal syndrome type 1 continues as the FDA issued the company a third complete response letter (CRL) for the drug.
Avinger Inc. has received U.S. FDA clearance for a its Ocelaris next-generation, image-guided chronic total occlusion (CTO) crossing system for patients with peripheral artery disease (PAD). The catheter-based system, which will be sold under the brand name Tigereye, provides real-time imaging from within the vessel during a CTO-crossing procedure. It will be available on a limited basis beginning later this year.
The rescission order directing the U.S. FDA to abandon regulation of lab-developed tests is scarcely three weeks in the past, but two senior managers at the FDA are pushing back in an editorial appearing in the New England Journal of Medicine. The FDA’s Jeff Shuren and Tim Stenzel wrote that there is “a need for a common legislative framework” to ensure clinical tests are accurate and reliable, which implicitly concedes that the statute does not authorize the agency to regulate lab-developed tests.
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