January 18, 2019
This morning Alphabet’s life science subsidiary Verily announced that its Verily Study Watch and its on-demand ECG feature landed a 510(k) clearance from the FDA.
The watch is a prescription-only device, and was designed to record, store, transfer and display single-channel ECG rhythms. The company said the device’s ability to take on-demand, single-lead ECG can be used for individual patient...
January 16, 2019
The National Institutes of Health made it clear from the start that Fitbit’s wearables would play a key role in the agency’s ambitious All of Us Research Program.
Now, eight months and more than 100,000 enrollees down the road, the agency and the device maker have announced that anyone who owns a Fitbit and has already enrolled in the program may consent to release the activity, heart rate, sleep...
December 20, 2018
This morning, Omron Healthcare announced that the HeartGuide wristwatch — a wearable oscillometric wrist blood pressure monitor unveiled earlier this year at CES 2018 — has received FDA clearance and will be available at retail on January 9, 2019. The device is currently available for preorder for $499.
The key feature of the product is a flexible synthetic band that is designed to inflate and...
December 17, 2018
With roughly a week to go before thousands of devices are unwrapped under the tree, Fitbit has pushed out a bevy of updates to its smartwatches that make it easier for wearers to quickly grasp their individual health performance.
Specifically, Fitbit OS 3.0 expands the Fitbit Ionic, Fitbit Ionic: adidas edition and Fitbit Versa’s dashboards to include new data on a wearer’s sleep, exercise and...
December 12, 2018
This morning, Garmin and medical-grade monitor maker ActiGraph announced a new partnership that will focus on wearables for medical research and patient care.
Specifically, the pair will be applying ActiGraph’s CentrePoint data analytics platform to Garmin’s consumer-grade wearables. CentrePoint is a web-based, cloud-enabled service offering automated activity monitor assignments, data...
December 11, 2018
Myia Labs, maker of a platform that applies AI health monitoring to consumer wearables, has raised $6.75 million in seed funding. BootstrapLabs and Zetta Venture Partners led the round, with the American College of Cardiology (ACC) and The Boston Consulting Group also participating.
Myia’s tech outfits Apple Watches, Fitbits and other devices with monitoring capabilities designed for patients...
December 4, 2018
De Novo rule proposal published for review. The FDA has published a new proposal for revisions to the De Novo regulatory pathway for devices without a predicate. The rule, which is currently available for public comment, aims to provide additional structure, clarity and transparency to the process, and outlines how the agency processes and gauges submitted devices.
“Our goal is to make the De...
November 27, 2018
Smart sock maker Sensoria is teaming up with the Michael J. Fox Foundation and independent research group Neuroscience Research Australia to launch a 100-patient clinical trial looking at what smart textiles in socks can do for Parkinson’s disease patients.
The trial, called Standing Tall-PD, is supported by a grant from MJFF. The first part of the study will test the potential for smart textiles...
November 26, 2018
Monitoring and automatically identifying the symptoms of Parkinson’s disease patients can be achieved using just a single soft wearable sensor placed on the back of the hand, according to an investigation recently published in NPJ Digital Medicine that sought to optimize such methods of data collection.
According to the researchers — who employed 20 participants, six different sensors and...
Photo: Courtesy of L'Oréal USA
November 19, 2018
Last week, L'Oréal announced that its La Roche-Posay My Skin Track UV—the first battery-free wearable electronic to measure UV exposure is available for sale through apple.com and select U.S. Apple Store locations.
La Roche-Posay My Skin Track UV measures both UVA and UVB rays, and provides instant status updates while storing up to three months of data. The battery-free sensor is activated by...