We are thrilled to announce that the Corsano CardioWatch 287-2 has received FDA 510(k) clearance for use in the United States. This milestone marks a significant step in our mission to bring clinical-grade wearable monitoring to healthcare professionals worldwide.
What This Means
The FDA 510(k) clearance confirms that our device meets the rigorous standards required for medical device commercialization in the United States. Specifically, the clearance covers:
- Continuous heart rate monitoring
- Heart rate variability (HRV) measurement
- Respiratory rate estimation
- SpO2 (blood oxygen saturation) monitoring
- Skin temperature measurement
This clearance allows healthcare providers, clinical researchers, and health coaches in the US to confidently use Corsano devices for patient monitoring applications.
A Rigorous Journey
Achieving FDA clearance required extensive validation:
Clinical Studies
We conducted multiple clinical trials across different patient populations, comparing CardioWatch measurements against gold-standard references:
- Heart rate validated against 12-lead ECG
- SpO2 validated against arterial blood gas analysis
- Respiratory rate validated against capnography
Quality Management
Our manufacturing facilities maintain ISO 13485 certification, ensuring consistent quality in every device produced.
Documentation
Over 1,500 pages of technical documentation, including bench testing, biocompatibility studies, and software verification reports.
Joining CE-MDR Certification
The FDA clearance complements our existing CE-MDR (Class IIa) certification in Europe, making Corsano one of the few wearable platforms cleared for clinical use in both major markets.
What's Next
With FDA clearance secured, we're accelerating US market expansion:
- Healthcare partnerships - Engaging with health systems and clinical practices
- Research collaborations - Supporting US-based clinical trials
- Coach platform expansion - Full support for US-based health coaches
Our Commitment
This clearance represents years of work by our engineering, clinical, and regulatory teams. It reflects our fundamental commitment: building wearable technology that healthcare professionals can trust for real clinical decisions.
Thank you to everyone who has supported us on this journey – our clinical partners, research collaborators, and the health coaches who push us to do better every day.
*Interested in using FDA-cleared Corsano devices in your practice? Contact our team or schedule a demo.*