The U.S. FDA granted Neuronetics Inc. clearance for use of its Neurostar advanced therapy as an adjunctive treatment of major depressive disorder in patients aged 15 to 21, making it the first transcranial magnetic stimulation treatment (TMS) cleared for this age group, the company said.

Less than two years after acquiring Sound United for $1.025 billion, Masimo Corp. plans to hive off the consumer audio subsidiary along with consumer health products such as its Stork baby monitor and Freedom smart watch and band. The “rushed” announcement made Friday “came after being informed that Politan intended to nominate directors this week,” said activist investor Politan Capital Management. Politan, which owns 8.9% of the company, secured two board seats in a highly contentious proxy battle last year and nominated two more on Monday morning.

The U.S. Department of Health and Human Services (HHS) was quite vocal in its statement regarding a recent hospital cybersecurity breach, but HHS recently suffered an undisclosed data breach that cost $7.5 million in taxpayer monies.

The U.S. FDA has posted another proposed ban of the use of electrical stimulation devices (ESDs) for the treatment of self-injurious behavior, which revisits the controversy over their use by the Judge Rotenberg Center.

The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement. The FDA noted that it has received 129 reports of serious injury and 49 reports of fatalities associated with these devices, but did not indicate whether device malfunction was the source of these adverse events. Abiomed advises customers that the device should be implanted “with special care” in patients during active cardiopulmonary resuscitation, and to review some updated warnings in the product’s instruction for use statement.

Stimlabs LLC received U.S. FDA approval for Corplex P, a wound care product that uses placental tissue to facilitate wound healing. “Corplex P is the first particulate device derived from human umbilical cord extracellular matrix indicated for the management of acute and chronic wounds,” Stimlabs CEO John Daniel told BioWorld.

A metabolite that suppresses appetite and food intake after exercise could be the reason for the weight loss observed in patients treated with metformin to control blood glucose. A study conducted by a group of scientists at Stanford University showed how this antidiabetic drug induced the biosynthesis of N-lactoyl-phenylalanine (Lac-Phe), which has an effect reducing the body mass index.

The latest filing from Orlando-based Noble International Inc.—an Aptar Pharma company—hints at the development of a new category of medical devices. Best known for its medical device training solutions and patient onboarding strategies, Noble filed for protection of a compression sleeve for monitoring and treating rheumatic disorders.

The U.S. FDA’s pending final rule for regulation of lab-developed tests has proven unusually controversial even for the FDA, but Rep. Anna Eshoo (D-Calif.) stated in a March 21 hearing that congressional inaction has left the agency in an uncomfortable spot.

An advocate general (AG) for the E.U. Court of Justice did not mince words in calling out the European Commission for its “very significant extension of the scope of the Merger Regulation and of the commission’s jurisdiction” in reviewing Illumina Inc.’s $7.1 billion acquisition of Grail LLC.