This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues. 

FDA announces $40,000 Naloxone App Competition at the start of Prescription Opioid and Heroin Epidemic Awareness Week through Sept. 23, when registration open for the competition, which closes Oct. 7.

Summary of recent device mergers and acquisitions, alliances, and financings.

Each month, Start-Up presents a comprehensive review of young, private life science companies that have recieved venture funding during the month, including companies in the pharmaceutical, medical device, diagnostic and research instrumentation & reagent sectors.