Alivecor Inc. has elevated its patent dispute with Apple Inc. to the U.S. International Trade Commission (ITC) in a move that could damage the latter’s foray into digital health. Alivecor is alleging that Apple, of Cupertino, Calif., has infringed on Alivecor patents for electrocardiogram monitoring technology, a development that may foreshadow a continuing legal struggle between the two companies for a large and rapidly growing market.
The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.
Fitbit Inc. and Apple Inc. picked up the pace in their race to put health monitoring apps on wrists everywhere with Fitbit gaining 510(k) clearance from the U.S. FDA for its new ECG app for the Fitbit Sense and Apple revealing the blood oxygen sensor built into its Series 6 watch this week. The new apps join a growing array of technological advances that permit wearable devices to track and record a range of health metrics.
Stanford University School of Medicine and Apple Inc.have published results from the largest digital-only study. The trial has been conducted in more than 400,000 people in the U.S. over more than eight months. It was set up to screen participants via their Apple Watch for heart irregularities and then to further monitor any of those with identified issues with a wearable ECG patch.