BETA
Publicly traded cardiac-device developer commercializing a portable ECG system while advancing heart-attack assessment and an extended-wear patch.
HeartBeam is a Santa Clara, California-based cardiac-device company incorporated in 2015 and listed on Nasdaq as BEAT. Its portable ECG recorder and synthesis software support clinician assessment of specified non-life-threatening arrhythmias in adults.
The company reported first shipments and patient onboarding in 2026. Its September strategy update describes focused, limited U.S. commercialization while pursuing partners rather than building a large sales and distribution organization.
Heart-attack assessment and an extended-wear ECG patch remain development programs. HeartBeam reported Breakthrough Device Designation for heart-attack assessment in October 2026; that designation does not expand the currently cleared arrhythmia indications.
HeartBeam has two 510(k) decisions covering its ECG platform and synthesized 12-lead ECG software for arrhythmia assessment. Company disclosures confirm the December 2025 software clearance despite stale conflicting homepage text. Heart-attack detection remains investigational; the 2026 pilot work is intended to inform a future pivotal study and submission, not an already-cleared indication. [5][13][14][1][2][21]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [23][24]
Latest recorded source review: 2026-10-20.
Scope: selected product families.
Documented commercial product families.
A patient-held three-direction ECG recorder with mobile and clinician software. The software-modified system can synthesize a 12-lead representation; it does not replace a standard diagnostic 12-lead ECG. [3][4][5][20][8][9][10][11]
FDA-clearedFocused, limited U.S. commercialization reported by HeartBeam in September 2026; broad availability and installed base not established.
Company reported an FDA development-program designation. It is not clearance, approval or a cleared indication. [19]
Shareholder letter prioritized MI research and patch partnering while retaining a limited arrhythmia launch. [20]
Prospectus permits up to $25 million in stock sales through Titan Partners; actual proceeds are not established by the filing. [6]
Quarterly update reported early commercial activity, rather than an independently verified installed-base total. [15]
The June 2026 Form 10-Q reported $8.7 million in cash and equivalents at June 30 and disclosed substantial doubt about continuing as a going concern. This is a dated filing, not a current cash balance or financial-health rating. [7]
Company reported pilot enrollment completion. This research does not establish a cleared heart-attack indication. [17]
Company announced Eno's transition from CEO and a partner-oriented operating structure. [2]
Approximately $11.5 million in gross proceeds reported, including the overallotment option. [15][27]
FDA cleared K250258, adding synthesis software to the platform. [4]
FDA cleared the AIMIGo System under K231424. [3]
Company FAQ dates its public-company transition to November 10, 2021; Nasdaq symbol BEAT. [1]
HeartBeam reports incorporation on June 11, 2015. [1]
Accessed 10/29/2026