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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

Breakthrough

HeartBeam takes a Breakthrough designation into at-home heart attack assessment

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via HeartBeam release

FDA granted HeartBeam a Breakthrough Device designation for assessing heart attacks outside a hospital. The Santa Clara company announced it on October 5.

The HeartBeam recorder is about the size of a credit card. It captures cardiac electrical signals along three non-coplanar axes, then synthesizes a clinical-grade 12-lead ECG from them. FDA cleared the 3D ECG hardware for arrhythmia assessment in December 2024 and the 12-lead synthesis software in December 2025. Myocardial infarction is a new indication, not an extension of either clearance.

HeartBeam says it will meet FDA on study design in the coming months and enroll patients after that. Breakthrough status buys earlier and more frequent agency interaction, not a smaller trial. An MI indication read outside a clinical setting will need evidence that the synthesized leads hold up against a standard 12-lead at the moments that matter.

Questions & Answers

What did HeartBeam receive FDA Breakthrough Device designation for?

FDA granted HeartBeam a Breakthrough Device designation on October 5, 2026 for assessing heart attacks outside the hospital using its 3D ECG system.

Is the HeartBeam system already FDA cleared?

HeartBeam holds two 510(k) clearances, both for arrhythmia assessment: the 3D ECG system in December 2024 and the 12-lead synthesis software in December 2025. Heart attack assessment is a new indication.

Where is HeartBeam based?

HeartBeam is based in Santa Clara, California and trades on Nasdaq under the ticker BEAT.

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