- Movano Health's (MOVE, Financial) cuffless blood pressure device surpasses FDA accuracy standards with a mean absolute difference of 4.9 mmHg.
- New prototype features 12 mmWave antennas for enhanced data collection and a slimmer design.
- A consumer-oriented device is anticipated within months, following pivotal trials for FDA clearance.
Movano Health (MOVE) has announced promising outcomes from its recent clinical study involving 81 participants for its innovative cuffless blood pressure monitoring device. The wrist-worn prototype achieved a mean absolute difference (MAD) of 4.9 mmHg, effectively surpassing the FDA's accuracy requirement of 7 mmHg MAD, as per wearables standards (IEEE1708a-2019).
The latest version of the prototype incorporates 12 additional mmWave antennas integrated with Movano's custom integrated circuit (IC), enhancing data collection capabilities and resulting in a more compact design. Beyond blood pressure, the device can monitor vital signs such as pulse rate, SpO2 (blood oxygen saturation), respiration rate, and ECG waveforms.
The clinical study, which received IRB approval, was conducted at the Movano Health Clinical Lab and compared the prototype's performance to that of a hospital-grade FDA-cleared blood pressure monitor. These advancements indicate Movano Health is taking significant steps towards a more consumer-friendly product expected to be available in the coming months, pending successful pivotal trials for FDA clinical requirements.
With over 122 million Americans suffering from hypertension and an additional 59 million experiencing prehypertension, Movano Health's cuffless blood pressure monitoring technology is poised to address a critical need in both the consumer and clinical markets. The company is actively preparing for a pivotal trial, which marks a crucial step on the path to eventual regulatory approval and commercialization. For more information, visit Movano Health's website at Movano Health.
