Former FDA Commissioner Stephen Hahn is being asked to spill the beans on political interference at the U.S. agency during the emergence of COVID-19 last year.

Medical science has not yet convincingly duplicated the remarkable properties of cartilage, an omission that sustains an epidemic of life-altering knee replacement surgeries. Anthony Ratcliffe, CEO of Synthasome Inc., of Del Mar, Calif., said on a recent FDA webinar that companies might want to consider the lowly goat as the animal model of choice in preclinical studies of cartilage products because “the cost, ease of management, and the social aspects were all manageable” with goats.

The FDA has issued new risk classification orders for two series of products, including in vitro diagnostics for hepatitis C, two of which the agency down-regulated from class III to class II. However, blood lancets for multiple uses on more than one patient has been elevated from class I to class III, a change that has no impact on any products currently available on the U.S. market.

Stryker Corp.’s analyst day provided comfort to those concerned about the company’s ability to return to its strong pre-pandemic revenue and earnings growth after its lower than expected third-quarter earnings results. Management offered positive reports of fourth-quarter trends and a long-term strategy unfolding according to plan.

The Health Breach Notification Rule set forth by the U.S. Federal Trade Commission in 2009 was not initially directed toward health apps used strictly for non-medical uses, but the FTC has indicated it will enforce the rule for developers of these non-medical apps as well. The risk is substantial for these developers as the civil penalties for breaches can reach $44,000 per violation per day, which in the case of a mass breach could present a profound financial risk.

For brain surgeons, the shift is the sticking point. When a surgeon opens the cranium to remove a tumor, the brain moves as much as 1 cm, making much of the pre-operative mapping of the tumor essentially useless. While the bulk of a lesion can be identified by its density, the tendrils blend into the surrounding tissue – and taking excess margins means more brain damage. Designs for Vision Inc.’s bright idea, a headlamp that illuminates a fluorescing tumor with a laser light, makes brain surgery quicker, safer and more accurate.

Artificial intelligence (AI) is quite the buzzword for med tech and regulators alike, but that doesn’t mean rules for AI are just over the horizon. Pat Baird, director of global software standards at Koninklijke Philips NV, said during a recent webinar that problems such as long-standing definitional issues virtually guarantee that regulatory agencies will struggle to enact regulations, a predicament that leaves software developers with the kind of uncertainty that investors in the life science industries abhor.

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.