FDA-cleared camera-based vital signs platform provides heart rate and breathing rate free of charge to hospitals, clinics, health organizations, and educators.

Presage Technologies announced today that SmartSpectra Vital Signs Monitor 1.0 SDK has obtained FDA 510(k) clearance (K254169) for iOS and Android - and is providing those cleared metrics without charge. Hospitals, clinics, global health organizations, and educational institutions can now access FDA-cleared contactless pulse rate and breathing rate monitoring using a mobile device camera, at zero cost.

"Over 90% of Americans have a smartphone, but more than 25 million lack access to regular healthcare, with affordability and accessibility being the primary drivers. We are making this technology free as part of our mission to close that gap," said Mark Oliver, Founder and CEO of Presage Technologies.

The FDA-cleared SmartSpectra measurement for iOS and Android requires no wearable sensors, physical contact, or specialized hardware. Separately, the broader SmartSpectra SDK platform is available across Mac, Linux, Windows, iOS, and Android, giving developers, businesses, and organizations access to contactless vital signs and remote health monitoring tools. The broader platform can also capture uncalibrated arterial pressure waveforms, breathing waveforms, heart rate variability, and facial expression analytics.

SmartSpectra met FDA accuracy standards - achieving an RMSE of 1.32 BPM for heart rate and 1.75 BrPM for breathing rate. Results are peer-reviewed and published.

Health screening, patient monitoring, and biometric screening historically required physical hardware, but Presage is leveraging the smartphone platform to increase accessibility and reduce costs.

The FDA clearance is the culmination of years of rigorous in-house validation and laboratory testing, alongside clinical trials at Baylor College of Medicine with a cohort of 111 participants spanning all skin tones, and a diverse set of ages and BMI groups.

"This has been years of work by an incredible team, and getting FDA clearance for camera-based vital signs is a moment we are really proud of. We have put a lot of work into making contactless health monitoring and remote health monitoring something that actually works in the real world. This milestone proves that our lean, high-velocity team can deliver clinical-grade accuracy that meets the same stringent standards as established medical device manufacturers. We are excited to keep building toward a future where contactless vital signs monitoring is something anyone, anywhere can access," said Jim Winkelmann, Chief Technology Officer of Presage Technologies.

FDA 510(k) clearance means SmartSpectra's accuracy has been held to the same standard the FDA applies to the remote patient monitoring devices and remote monitoring devices that clinical teams rely on today. For RPM health care companies, AI healthcare companies, and medical device manufacturers, the SmartSpectra SDK provides access to the same validated, peer-reviewed technology through iOS, Android, Mac, Linux, and Windows.

Presage Technologies has also launched Coherence by Presage Tech, a remote vital signs monitoring app available for consumers and for businesses looking to offer contactless vital measurement to their users. The app is available now on the Apple App Store and for a limited number of devices on the Google Play Store. Developers and device manufacturers can build with the SmartSpectra SDK to integrate the same underlying technology into their own products. Everything is available at presagetech.com.

ABOUT PRESAGE TECHNOLOGIES

Presage Technologies transforms standard cameras into health monitoring, screening, and therapeutic solutions. SmartSpectra, the company's flagship vital signs software development kit, delivers FDA-cleared heart rate and breathing rate monitoring, enabling remote health monitoring, patient monitoring, and contactless health monitoring via smartphones and consumer, camera-equipped devices. The platform also measures heart rate variability (HRV) and electrodermal activity, with ongoing work in contactless blood pressure monitoring. Presage serves healthcare, government, and wellness markets and is based in Leesburg, Virginia, USA.

For more information, visit presagetech.com or follow Presage Technologies on LinkedIn.

SOURCE Presage Technologies