The FDA is hopeful that devices like the new Apple (NSDQ:AAPL) Watch, which is designed to provide on-the-spot electrocardiogram tests and detect atrial fibrillation, will lead to a “reimagination of healthcare delivery,” according to a recent post from agency head Dr. Scott Gottlieb, but whether having that data will improve overall health has yet to be seen.
In its unveiling of the new Apple Watch 4, the Cupertino, Calif.-based tech giant said it worked closely with the FDA to clear the device, which won de novo classification from the federal watchdog.
Gottlieb confirmed that the agency “worked closely with the company as they developed and tested” the products, adding that the agency is hopeful that such devices could help users find treatment earlier and “truly empower them with more information about their health,” according to the post.
“As a public health agency, we’re encouraged to see interest from developers in entering the digital health marketplace. And we want developers to know that the FDA stands ready to work with you to bring your safe, effective and innovative products to market. Our message today is clear—we want software developers to create new, innovative technologies that can help consumers take control of their health. As regulators, we will put patient safety at the forefront of what we do. And we will continue to work with developers to ensure their safe, effective and innovative products can enter the market,” Gottlieb wrote in his poting.
While the agency touted the device as a major step forward, the clearance wasn’t a first – last November, the FDA cleared the KardiaBand ECG accessory from AliveCor, which is designed to be used with the Apple watch to provide detection of both atrial fibrillation and hyperkalemia, or high potassium levels in the blood.
Studies of the KardiaBand showed the device to be capable of differentiating between AF and normal heart rhythms with accuracy similar to a standard-of-care 12-lead EKG. The device was also shown to be able to detect hyperkalemia, which is associated with major heart complications, at a 90% to 94% accuracy level.
Apple has not yet released data from any studies of its Apple Watch device, and the clearance came with caveats, according to a Gizmodo report.
Though the device is cleared to function as an EKG, the FDA specified that the application and watch are not meant to be used by people younger than 22, and said that the device is not recommended for people with other known heart conditions that could disturb their heart rhythm, according to the report.
Documentation on the clearance also includes the caveat that the Watch and associated app are “not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the presence of a notification is not intended to indicate no disease process is present,” according to Gizmodo.
And while the FDA is optimistic that putting more data in the hands of consumers will improve overall health, other devices, such as over-the-counter baby pulse oximetry devices intended to give parents peace-of-mind, have come under fire for accuracy issues and for adding unnecessary stress.
Last month, a report published in the Journal of the American Medical Association warned that the use of baby monitors intended to track physiological conditions could be inaccurate and cause more stress than necessary for parents.
Researchers also warned that the market for vital signs monitors, which is “largely unregulated,” is quickly growing, and that such devices could cause unnecessary anxiety with no evidence of benefits.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
Use code WOMENSHEALTH to save an additional 10%.