BETA
Digital stethoscope and software supporting clinician-guided remote examinations and home auscultation.
Medaica offers the M1 Telehealth Stethoscope and connected software for listening to and sharing heart, lung and other body sounds. Its platform supports live remote examinations and recordings, aiming to extend physical assessment beyond a conventional office encounter.
The FDA-cleared M1 is an electronic stethoscope; its clearance is documented under K223166. The current regulatory page distinguishes device use and supporting software. General platform or AI ambitions should not be interpreted as separate diagnostic authorizations.
Stephen Randall is CEO, Pablo Rivas is President and CFO, and Mark Gretton is CTO. The business combines a patient-facing device with clinician workflows and telehealth partnerships. Current pricing, reimbursement and deployment scale require separate verification and are not estimated here.
Medaica’s M1 Telehealth Stethoscope and system software are FDA-cleared under K223166. The clearance is for the specified auscultation system and users; references to AI-assisted reports do not establish a separate autonomous diagnostic authorization. [8][10][11][2][9][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [6][4]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Electronic stethoscope with software-supported live and recorded auscultation workflows. [8][11]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial electronic stethoscope; no separate AI diagnostic authorization established. [8][10][11]
FDA database decision date is January 19, 2023; clearance letter is dated January 20. [11]
Accessed 10/20/2026