FDA highlights risks of evaluating blood pressure with unauthorized medical devices
The U.S. Food and Drug Administration (FDA) has issued a new warning about the risks associated with using unauthorized devices to measure or estimate blood pressure levels. The agency emphasized that only FDA-approved devices should be used for this purpose, and many of the available over-the-counter technologies have not been properly evaluated.
“Inaccurate blood pressure measurements can lead to errors in diagnosing hypertension or hypotension, which may result in delayed treatment or lack of treatment,” the FDA wrote. “This can lead to patient harms, such as stroke, heart attack, heart failure, kidney failure, cognitive decline, and early death. Because high blood pressure often has no physical symptoms, accurate measurements are critical to preventing serious complications.”
The agency also urged healthcare providers to discuss this topic at length with patients and help them select authorized devices to perform blood pressure measurements.
Apple’s recent victory in the battle against hypertension
One of the FDA’s primary concerns is limiting the public’s use of unauthorized medical devices. That makes the timing of this advisory especially noteworthy—the agency just cleared an advanced artificial intelligence algorithm for the Apple Watch Ultra 3 specifically designed to help detect early warning signs of high blood pressure. Instead of using a cuff to measure an individual’s exact blood pressure, the Apple Watch algorithm tracks their long-term health over 30-day periods of time. Then, the algorithm examines those 30-day findings and presents a warning if it seems the patient may benefit from a clinical evaluation.
Cardiologists, general practitioners and other industry stakeholders appear to agree that the FDA’s decision to clear this feature represents a significant breakthrough for identifying more patients with hypertension.
"This tool empowers patients and clinicians to work together, putting prevention at the center of care,” Ami B. Bhatt, MD, chief innovation officer of the American College of Cardiology and chair of the FDA Digital Health Advisory Committee, told Cardiovascular Business when the Apple Watch Ultra 3 was first presented to the public.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.