All Takeda is trying to do with its billions-of-dollars worth of licensing deals in gene therapy is cure rare disease. Simple, right?

Swiss biotechs saw record-breaking revenue and R&D investment in 2021, which the industry hopes will lead people to look beyond homegrown giants like Roche and Novartis.

Seemingly still dissatisfied with Philips’ handling of its ongoing respiratory device recall, the FDA is now considering taking further action to force the Dutch medtech to tighten up its response to the safety event.

Using simplified ECG data taken from an Apple Watch, researchers at the Mayo Clinic were able to use an artificial intelligence algorithm to spot people whose hearts may be having trouble pumping blood out to the rest of the body.

A tough call from the FDA has led Spero Therapeutics to become the latest in an ever-growing line of biotechs taking evasive action to stay afloat. The company will halt the commercialization of its late-stage urinary tract infection drug and lay off three-quarters of its staff.

Though mammograms are seen as the current “gold standard” for breast cancer diagnosis, ultrasounds can actually provide a more accurate image of the breast tissue in younger women and others with denser tissue in addition to offering a less expensive, radiation-free alternative to mammography.

Compass Pathways has early evidence that its psilocybin therapy can improve outcomes in people with anorexia nervosa. Working with anorexia expert Walter Kaye, M.D., the British biotech showed 40% of subjects in the small study experienced clinically significant reductions in eating disorder psychopathology after a single dose of the active ingredient in magic mushrooms.

The tooth fairy isn’t the only one granting dentistry-related wishes. The FDA bestowed a 510(k) clearance upon an artificial intelligence algorithm from VideaHealth that can help dentists identify cavities in patient X-rays.

The FDA has rejected Axsome Therapeutics’ migraine med, an expected result after the company disclosed last week that issues with its chemistry, manufacturing and controls (CMC) had been deemed unresolved by regulators.

Digital X-ray company Nanox has secured a new FDA clearance for its artificial intelligence program that spots compression fractures in the spine, adding the ability to spot areas of low bone density. Both are hallmarks of osteoporosis.