HeartBeam Wins FDA Breakthrough Status for At-Home Heart Attack Assessment
FDA granted HeartBeam Breakthrough status for its 3D ECG heart-attack tool. Priority review follows; clearance is still required.
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HeartBeam Gets FDA Green Light for Home Heart Monitoring Device
HeartBeam receives FDA clearance for credit-card sized device that delivers 12-lead ECG heart readings at home for arrhythmia detection without cables or wires.
HeartBeam Pursues Multiple Paths After FDA Setback
HeartBeam responds to FDA's NSE decision on its 12-lead ECG software with appeal plans and labeling modifications to advance heart monitoring technology.
HeartBeam Receives FDA Setback on ECG Software Application
HeartBeam receives NSE letter from FDA for 12-Lead ECG software but plans alternative product launch with already-cleared 3D ECG system.
Roth Capital and BTIG Initiate Coverage on HeartBeam and Connect Biopharma with Buy Ratings
Roth Capital starts coverage on HeartBeam (BEAT) with a $4 target, while BTIG initiates on Connect Biopharma (CNTB) with a $10 target. Both firms see strong growth potential in innovative healthcare technologies.