Page 3 - Breakthrough Devices News Today

Also: Wysa receives FDA Breakthrough Device Designation for its mental health chatbot, and Pear Therapeutics expands its telehealth partnership program.

Also: Pear Therapeutics receives FDA SteP designation for its product candidate focused on acute and chronic pain, and Carbon Health launches its diabetes management program.

Mojo Vision announced a new prototype of its augmented reality contact lens technology

In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high...

/PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac...

MONMOUTH JUNCTION, N.J., Jan. 18, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening cond...

The Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary final rule from the Trump admin would have granted expedited Medicare coverage for up to 4 years for certain FDA-designated breakthrough devices having cleared market authorizations.

Press release content from PR Newswire. The AP news staff was not involved in its creation.

/PRNewswire/ -- MCRA, LLC, a leading medical device, in-vitro diagnostic, and biologics advisory firm and clinical research organization (CRO) integrating U.S....

On September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) published a proposed rule, which (if finalized) would repeal the Agency’s Medicare Coverage...