Neuroem Therapeutics Inc. has received breakthrough device designation from the U.S. FDA for Memorem, a bioengineered, wearable head device for the treatment of Alzheimer’s disease. The breakthrough nod, which entitles companies to an expedited regulatory process, follows results from a pilot study showing Memorem can reverse memory loss in patients with the debilitating brain disorder.

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.

In August, Cala Health Inc. reported results from its pivotal PROSPECT study showing significant improvement in hand tremors with use of its Cala Trio wearable neuromodulation therapy. Now the company has real-world evidence affirming the benefit to patients with essential tremor (ET) who used Cala Trio at home over several months.

TORONTO – After four years of relying on Vivametrica Inc. to successfully boost the health and wellness of its clients’ employees, Sprout Wellness Solutions Inc. has taken the next logical step by acquiring the Calgary-based health analytics company.

HONG KONG – Chugai Pharmaceutical Co. Ltd. is hoping to start phase I trials for an as-yet-unnamed digital solution for measuring pain levels in endometriosis patients that it is co-developing with Biofourmis Inc.

Commercial continuous glucose monitors (CGMs) require some access to a patient’s blood, typically through tiny needles embedded in a wearable patch sensor. But Movano Inc. is working to develop a CGM that is based on radio frequency technology to monitor glucose levels via a noninvasive, external wearable, likely in a form factor akin to a watch or a wrist-worn fitness wearable.

The case of Fitbit Inc. v. Valencell Inc. has seen the usual number of twists and turns as it wended its way through Article III courts and an inter partes review (IPR), but a U.S. Supreme Court case that requires that all claims in an IPR be reviewed was decided during the Fitbit IPR.

TORONTO – Edmonton’s University of Alberta is lending its neuromotor research smarts to a wearable, machine learning driven sensors platform developed by Menlo Park, Calif., and Calgary, Alberta-based Protxx Inc. for better managing the future care of patients suffering from neurodegenerative conditions such as multiple sclerosis (MS).

Hydrocephalus involves the buildup of excess fluid in the brain. It affects more than 1 million people in the U.S. – most of them children – and can result in brain damage and related neurological impairments. Shunt implants are the standard treatment to drain that fluid, but more than half of them fail within the first couple of years of placement.

Amsterdam-based Royal Philips NV has launched a five-day, wearable biosensor patch that monitors respiratory and heart rates once every minute, as well as assesses contextual information such as posture, activity level and ambulation. The wearable, disposable patch, dubbed the Philips Biosensor BX100, has received FDA clearance and a CE mark and is intended for use in lower acuity hospital care.