NetworkNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Receives FDA Breakthrough Device Designation for At-Home Heart Attack Assessment
HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care, received U.S. Food and Drug Administration “FDA” Breakthrough Device Designation for the HeartBeam System as a tool for assessing potential heart attacks at home. The designation recognizes the potential of HeartBeam 3D ECG technology to enable physicians to evaluate signs of a possible heart attack when symptoms begin, wherever the patient may be. The FDA granted the designation within 30 days of HeartBeam request, ahead of the agency 60-day statutory review period.
HeartBeam said the designation provides prioritized FDA review and interaction as it advances its heart attack assessment program and is a prerequisite for certain expedited Medicare coverage pathways. The company expects to seek FDA alignment on the design of a multicenter pivotal study in the coming months and anticipates beginning patient enrollment shortly thereafter. If successful, the study is intended to support a future submission to expand the HeartBeam System indications to include heart attack assessment.
To view the full press release, visit https://nnw.fm/FxKxf
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care, received U.S. Food and Drug Administration “FDA” Breakthrough Device Designation for the HeartBeam System as a tool for assessing potential heart attacks at home. The designation recognizes the potential of HeartBeam 3D ECG technology to enable physicians to evaluate signs of a possible heart attack when symptoms begin, wherever the patient may be. The FDA granted the designation within 30 days of HeartBeam request, ahead of the agency 60-day statutory review period.
HeartBeam said the designation provides prioritized FDA review and interaction as it advances its heart attack assessment program and is a prerequisite for certain expedited Medicare coverage pathways. The company expects to seek FDA alignment on the design of a multicenter pivotal study in the coming months and anticipates beginning patient enrollment shortly thereafter. If successful, the study is intended to support a future submission to expand the HeartBeam System indications to include heart attack assessment.
To view the full press release, visit https://nnw.fm/FxKxf
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
