New Apple Watch adds FDA-cleared ECG application

Dive Brief:

• Apple stepped further into the healthcare arena on Wednesday, touting FDA approval of a first-of-its-kind electrocardiogram monitor embedded in its latest Apple Watch.
• The ECG app, cleared though the agency's Center for Devices and Radiological Health's De Novo pathway, has been classified as a Class II medical device by the agency. It is indicated for over-the-counter use, but the agency notes in its approval letter that it is not intended for those under the age of 22.
• Separately, Apple also received a De Novo clearance for an application meant to identify irregular hearth rhythms that may suggest atrial fibrillation. The application provides an alert to users, but Apple COO Jeff Williams and the approval letter both noted that it will not catch every instance of AFib. 

Dive Insight:

FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren praised Apple's work with the agency during software development, calling it indicative of the innovation FDA would facilitate in its proposed Center of Excellence for Digital Health.

"The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health," Gottlieb and Shuren said in a joint statement.

But the ECG App has limitations, according to FDA. The data is not intended for diagnosis, and is not recommended for users with other known arrhythmias.  

"The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment," wrote Angela Krueger, deputy director of CDRH's Engineering and Science Review Office of Device Evaluation.

Further, false positives resulting in unneeded procedures and false negatives that miss actual diagnosis are a risk, the FDA said in its letter.

Apple notes that that any readings from the applications are stored in its Health app in a PDF that can be shared with a physician. "The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional," Krueger said.

Ethan Weiss, a cardiologist at the University of California San Francisco, told MedTech Dive that the utility of Apple's ECG App is heavily dependent on how specific the application is.   

"If it is scaring people and having them email their doctors all the time, it's going to be a big burden," Weiss said. "I think there is going to be an increase in the number of things that we all see, that isn't necessarily bad, it could be great."

AliveCor, which received FDA clearance for its KardiaBand application for use with Apple Watch last November, is set to face heavy competition now that Apple has integrated a similar product directly into its newest Apple Watch. But earlier this week AliveCor gained breakthrough device status from FDA for a software platform that aims to screen for hyperkalemia, or elevated blood potassium levels.

Another feature from the new Apple Watch monitors users for hard falls. According to Apple, the watch will give the user a chance to dismiss an alert before calling emergency services after 60 seconds. Taken with the ECG App and its AFib feature, it appears that Apple is making a play for older consumers with its newest offering.