Presage Technologies has received U.S. FDA 510(k) clearance for SmartSpectra Vital Signs Monitor 1.0 SDK, a contactless vital signs monitoring software tool for iOS and Android.
The FDA-cleared measurement can capture pulse rate and breathing rate using a mobile device camera, without wearable sensors, physical contact or specialised hardware. Presage is also making the cleared metrics available at zero cost for hospitals, clinics, global health organisations and educational institutions.
This is relevant because vital signs monitoring remains dependent on hardware availability, staffing and care setting. In remote health, community screening and low-resource environments, even basic measurement tools can become a barrier when patients or clinicians do not have access to compatible devices.
SmartSpectra is designed to turn standard cameras into clinical-grade monitoring tools. The company said the cleared measurement achieved root mean square error of 1.32 BPM for heart rate and 1.75 BrPM for breathing rate, with peer-reviewed and published results.
The platform is positioned for use across remote patient monitoring, patient screening, biometric screening and digital health applications. Beyond the FDA-cleared iOS and Android measurement, the broader SmartSpectra SDK is available across Mac, Linux, Windows, iOS and Android, giving developers and healthcare organisations a way to integrate contactless monitoring into their own products.
The development is relevant because remote monitoring companies, AI healthcare developers and medical device manufacturers are seeking ways to reduce hardware dependence. If validated camera-based monitoring can be embedded into existing smartphones or camera-equipped devices, it could lower deployment cost and simplify patient access.
Presage has also launched Coherence by Presage Tech, a remote vital signs monitoring app available for consumers and businesses that want to offer contactless measurement to users. This gives the company both a developer-facing SDK route and an application route to market.
