Apple is cooking up something for the iPhone and Apple Watch. An eagle-eyed reporter found some really interesting things from the company's recent job listing.
Is Apple about to build a new health sensor?
iPhone and Apple Watch Health Sensor Upgrade
Earlier this year, Apple enthusiasts and leakers hinted at a possible new health sensor for the Apple Watch that includes a blood sugar sensor that actively reports the wearer's health levels in real-time.
Though Apple has not confirmed such a feature, it looks like the tech giant is looking into building a team for its Health and Wellness products.
My Healthy Apple was the first to report the Regulatory Project Manager job listing Apple posted on its career site.
The role is in the "Hardware" division focusing on the suite of Health and Wellness products offered for the iPhone and Apple Watch. They will be in charge of regulatory support from product submissions, approvals, and launch readiness.
Apple also hinted that the Regulatory Project Manager will be helping in crafting solutions "the world doesn't know of yet!"
Apple is looking for someone who has worked with a digital health product or a Class II medical device with a strong software element to the product, Forbes said. This must be someone who understands the regulatory submissions requirements for FDA Class II Medical devices in both the U.S. and international market. They must have a proven track record of driving regulatory submissions and approvals as well. Having experience with FDA/GMP/Quality Systems per ISO 13485 requirements was stressed.
Class II medical devices are devices that have a moderate to high risk to the patient or user. According to My Healthy Apple, 43 percent of medical devices fall under this category. As of recent, most software as a medical device or SaMD fall under the Class I category.
The new FDA regulations are also changing the way these classifications will be awarded, which is why Apple is looking for someone who is very familiar with how FDA conducts its proceedings.
As the company is keeping news about its future endeavors in the dark, it is unclear if the position opening is related to any of the upcoming iPhone and Apple Watch scheduled for this fall.
Apple Watch Health Sensor Leaks and Rumors
Apple has been keeping details of its upcoming Apple devices under wraps. The rumored blood glucose levels sensor is one that sticks out the most. Companies that collect data from minimally invasive glucose sensores and provide metabolic health insights currently are not required by the FDA to pursue proceedings, My Health Apple said.
Dexcom was the first company to have its continuous glucose monitoring system or CGMS by the name of G6 classified as a Class II medical device.
It is also possible that Apple may be working with Rockley Photonics, a British start-up, to evaluate and integrate new health sensors into its products.