The FDA’s warning letter to Whoop Inc. resurrects questions about the agency’s observance of the 21st Century Cures Act in that the warning letter stakes out the position that any reading of blood pressure is “inherently associated” with hypertension.
A new position paper from the International Society of Hypertension pinpoints the benefits and drawbacks of novel blood pressure management technology, including the latest cuff-based and cuffless and wearable devices like BP-measuring watches and rings.
Aktiia SA’s wrist-worn, continuous blood pressure monitor, which has been in use in the EU since 2021, could soon be coming to the U.S. The Aktiia bracelet uses photoplethysmography, the technology perhaps best known for providing blood oxygenation readings via pulse oximeters, and an algorithm based on thousands of readings to estimate blood pressure as wearers go about their daily activities.
Biobeat Technologies Ltd. expanded its U.S. FDA-cleared remote patient monitoring offerings with a double nod from the agency for its sensors to monitor stroke volume and cardiac output. The two new indications join its capabilities for measuring the five vital signs assessed in any medical visit—blood pressure, blood oxygen saturation, pulse rate, respiratory rate and body temperature—all of which can be done using photoplethysmography (PPG) on sensors embedded on either a short-term chest patch or a more durable wrist monitor.
