The designation gives HeartBeam prioritized FDA interaction as it prepares a pivotal study of its 3D ECG technology for ...

Medical technology provider HeartBeam, Inc. BEAT received Breakthrough Device Designation from the U.S. Food and Drug ...

HeartBeam, Inc. (NASDAQ: BEAT) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to the HeartBeam System for assessing potential heart ...

The FDA's Breakthrough Device Program is intended to speed the development and review of technologies that may provide more effective diagnosis or treatment of life-threatening conditions. The ...

HeartBeam (BEAT) stock jumped 62% after the FDA granted Breakthrough Device Designation for its at-home heart attack ...

New medical devices deemed "breakthrough" by the FDA are no longer automatically eligible for extra Medicare payments.

HeartBeam announced the FDA has granted Breakthrough Device Designation for the HeartBeam System as a tool for assessing potential heart attacks at home. The Breakthrough Device D ...

CorTec's brain-computer interface (BCI) has obtained breakthrough device designation from the US Food and Drug Administration (FDA) for use in stroke rehabilitation. Under development for brain-based ...

Medtronic plans to study the device in patients with peripheral artery disease below the knee, a historically difficult ...

Heartbeam Inc (NASDAQ:BEAT) shares surged as much as 90% Monday after the company announced the U.S. Food and Drug Administration granted Breakthrough Device Designation for its at-home heart attack ...

VS3 Medical announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its VS3 System.

The United States Food and Drug Administration (FDA) issued guidance on its “Breakthrough Devices Program” in 2023. The program grants a designation to certain medical devices that provide more ...