Future Cardia

Implantable Cardiac Monitor

Focus consolidated the software design documentation for Future Cardia’s implantable cardiac monitor system, aligning it with IEC 62304 to support an FDA 510(k) submission

Future Cardia is developing an implantable cardiac monitor that is placed under the skin in about two minutes, during a routine office visit. The device tracks the heart continuously with several sensors: ECG, heart and lung sounds, and an accelerometer. It’s designed to be more accurate than wearables and to keep patients on monitoring longer, while fitting into existing reimbursement structures.

FDA 510(k) Documentation
IEC 62304 Software Lifecycle
Implantable Cardiac Monitor (ICM)
Traceability & Documentation Remediation

What We Built

Focus collaborates with Future Cardia, bringing its expertise in hardware and firmware development and in the verification and quality control processes that help the device meet the regulatory requirements for approval and commercialization. Focus applied that expertise to consolidate and remediate the software Design History File for Future Cardia’s implantable cardiac monitor system. The result is a single, traceable documentation set aligned with IEC 62304 and ready to support the 510(k) submission.

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Impact

Focus’s combined engineering and quality work helps Future Cardia move its Class II implantable cardiac monitor toward regulatory approval and commercialization.

510(k)-ready documentation

The work supports Future Cardia’s FDA submission for a Class II implantable device.

Single, traceable software DHF

The software design documentation is consolidated into one set, aligned with IEC 62304.

Engineering + quality expertise

Hardware, firmware, verification and quality control in one partner.