Category: Breakthrough Device Designation

  • CMS is prioritizing healing heart valves over bolstering brain health

    Our analysis demonstrates that CMS’s coverage processes for breakthrough devices demonstrate product class and disease state disparities. These disparities contradict mental health parity statute, CMS Administrator Brooks-LaSure’s focus on equity, and President Biden’s charge to improve brain health.

  • Pear claims breakthrough tag for alcohol use disorder DTx

    Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic (DTx) for people with alcohol-use disorder. The DTx – also known as Pear-009 – is still in the proof-of-concept trial stage, but draws on the same cognitive behavioural therapy (CBT) deployed in Pear’s commercial-stage products reSET and […]

  • FDA gives breakthrough status to Biofourmis’ heart failure DTx

    A digital therapeutic for patients with heart failure has been awarded breakthrough device status by the FDA – said by its developer Biofourmis  to be the first time the US regulator has given this designation for this type of product. Boston-based Biofourmis claimed the accolade for its BiovitalsHF prescription digital therapeutic (DTx), which is used […]

  • Roche’s Elecsys GDF-15 Assay Receives the US FDA’s Breakthrough Device Designation as a CDX in Cancer Treatment

    Shots: The US FDA grants the BDD for Elecsys GDF-15 assay that is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients aged≥18yrs. with solid tumors for treatment with Pfizer’s PF-06946860 GDF-15 assay helps to identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients and may provide a precision […]