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.
China’s National Medical Products Administration has cleared China Grand Pharmaceutical and Healthcare Holdings Ltd. to advance radiopharmaceutical agent ITM-11 (177Lu-edotreotide) to phase III trials in gastroenteropancreatic-neuroendocrine tumors
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.
Ultrahuman Healthcare Private Ltd. recently raised $35 million in a series B investment round to accelerate the company’s growth. Ultrahuman has developed several products, most notably a smart ring, which measures a range of physiological signals to impact health and wellbeing.
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.