Posted 14 August 2017
By Zachary Brennan
Last week, tech behemoth Apple signaled its interest in further pursuing the development of new medical devices with a new patent granted for an electronic device that "computes health data."
According to the patent, the device computes health data based on sensors and electrical contacts with one or more body parts of the user.
The device, comprised of a camera, an ambient light sensor, a proximity sensor and a processing unit communicably coupled to the camera, offer a glimpse into ways the iPhone manufacturer may look to compete with medical device companies beyond its ResearchKit and other apps.
The type of data the device may track, according to the patent, includes blood pressure index, blood hydration, body fat content, oxygen saturation, pulse rate, perfusion index, an electrocardiogram, which is used to track electrical heart activity, and a photoplethysmogram, which is columetric measurement of an organ.
The patent also shows Apple may use the device to communicate with a database maintained by a doctor and/or other medical or health provider.
And it follows reports from April that Apple is working on a device that can noninvasively and continuously monitor blood sugar levels to better treat diabetes. Apple also recently teamed up with glucose monitoring firm Dexcom to integrate data from Dexcom’s glucose sensors to Apple watches.
What remains to be seen is if Apple will seek US Food and Drug Administration (FDA) approval or clearance for any of its devices in development (Dexcom’s continuous glucose monitoring system is approved by FDA).
The 21st Century Cures Act amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions, including some described in FDA’s mobile medical applications guidance. And FDA says it is "assessing how to revise this guidance to represent our current thinking on this topic."
Under the guidance’s appendix listing "Examples of mobile apps that are the focus of FDA’s regulatory oversight," the agency points to "apps that are used in active patient monitoring or analyzing patient-specific medical device data from a connected device," among others.
Meanwhile, the agency has also unveiled a "Digital Health Innovation Action Plan," offering a vision for the Center for Devices and Radiological Health’s (CDRH) efforts.
The agency is also working on a precertification pilot project under which nine software developers will participate in a verification process beginning 1 September 2017.
Apple did not respond to a request for comment.