AliveCor has spent years battling with Apple over the market for consumer heart monitoring technology. Now it’s hoping to make its imprint on professional health care with its new device, which ...
HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software Application ...
HeartBeam (BEAT) announced its regulatory strategy following receipt of a Not Substantially Equivalent, or NSE, decision on the company’s 510(k) ...
SANTA CLARA, Calif.--(BUSINESS WIRE)-- HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced it ...
Recognized As A Top Global Innovator In Portable ECG Technology. <li /> The company was ranked second worldwide out of 243 companies evaluated in 12-lead ECG innovation in PatentVest's“Total Cardiac ...
Twelve-lead ECGs, although standard in hospitals, can be bulky and impractical for home use. On the other hand, Apple Watch’s ECG app is easy to use, but it is limited in what it can detect because it ...
Heartbeam Inc. has been awarded a patent for what it called “the first and only” 3D-vector, 12-lead ECG platform for heart attack detection, this in conjunction with a credit card-sized device inside ...
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HeartBeam Stock Slumps After FDA Refuses Clearance For ECG Software
Roth Capital sees potential FDA clearance for the software. ・The FDA may want the company to use a different predicate device, pursue a different regulatory pathway, or provide additional data, the ...
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