In a press release today, the Food and Drug Administration announced the list of companies chosen to be a part of its new pilot program that allows said companies to get pre-clearance for the creation of innovative health technology. Outside of Apple, the companies selected were FitBit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool and Verily. These companies now get to "jump the line" re: formal approval processes as long as they provide the FDA with access to their methods for testing and scrutinizing their software and facilities.
FDA Commissioner Dr. Scott Gottlieb stated that the program was created in order to better and more quickly facilitate advancements in the field of medical technology:
Our method for regulating digital health products must recognize the unique and iterative characteristics of these products. We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.
In the case of Apple specifically, this could mean more rapid improvement of the health-based features of the Apple Watch — the heart rate monitor, for instance. According to Apple Insider, there have also been some fairly recent rumors that Apple has hired a team of biomedical engineers to develop a non-invasive method of testing an Apple Watch wearer's glucose levels. That way, individuals with or at risk for diabetes could more efficiently monitor their health without the fuss of strips and extra devices.
Questions?
What do you think about the FDA's new program? If you're someone who frequently uses the health-related features on your device, do you feel that the program is a positive or negative for you? Give us a shout in the comments.
