The U.S. FDA granted the de novo marketing request for Bluewind Medical Ltd.’s Revi system for the treatment of urgency incontinence with or without urinary urgency, the company reported on August 17. Unlike other neuromodulation devices approved in recent years, Revi stimulates the tibial nerve instead of the sacral nerves.

Masimo Corp.’s Opioid Halo, an opioid overdose prevention and alert system, was granted de novo status by the U.S. FDA. The device detects opioid-induced respiratory depression, the primary cause of opioid deaths. The de novo authorizes the company to make Halo available over the counter and by prescription for use on individuals aged 15 and up.

Medasense Biometrics Ltd. received U.S. FDA marketing authorization for its PMD-200 patient monitor with nociception level index (NOL) technology that monitors patients’ physiological response to pain during surgery. NOL uses a multi-parametric sensor platform combined with artificial intelligence (AI) algorithms to generate a ‘signature of pain’ for patients under anesthesia who are also receiving opioids and other analgesics.

Playwright George Bernard Shaw is credited with coining the phrase, “better late than never,” a piece of advice the U.S. FDA seems to have taken to heart when it comes to posting the regulations for first-of-a-kind devices. The agency has posted eight regulations for de novo devices just between Jan. 4 and Jan. 5, 2023, five of those arriving on the latter of those two days in a post-holiday scramble to catch up.

The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.

The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.

Glaciers are known to move slowly, but so is government, and the FDA needed seven years to make effective an order that cerebrospinal fluid shunts be deemed class II devices. The classification was applicable as of Aug. 22, 2014, in connection with a de novo petition filed by no less than industry colossus Medtronic plc, of Dublin, in a process that began in 2012, possibly earlier.

The FDA’s regulation of medical technology may be assumed to have a number of unintended consequences, and one of those seems to be the lawsuit between Johnson & Johnson (J&J) and Auris Health Inc. Due to a 2018 FDA policy change regarding 510(k) devices, a robotic surgery system acquired by a J&J subsidiary from Auris was forced into the lengthier de novo premarket channel. This change ultimately helped derail the development effort for the Auris Iplatform surgical system and thus played a role in the $2.35 billion lawsuit alleging that J&J had engaged in fraud in its deal with Auris over the acquisition.

The FDA’s device center is required to develop and publish special controls for devices that are deemed class II items via the de novo petition process, and five such declarations were posted Dec. 1 to the Federal Register. One of these de novo classifications, for conditioning tools for eating disorders, was the subject of a de novo petition filed in 2007 and granted in 2011.

Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.