Regulation

A close up of a person wearing the Cionic Neural Sleeve
Cionic earns FDA clearance for leg-worn device to improve mobility
By Emily Olsen | 02:36 pm | March 08, 2022
The Neural Sleeve uses electrical stimulation to help people with neurological conditions walk more easily.
An image of the software detecting a fracture near a patient's hip
GLEAMER scores FDA 510(k) for AI-enabled fracture detection
By Emily Olsen | 05:15 pm | March 02, 2022
The BoneView software detects potential fractures in X-rays and submits them to radiologists for validation.
FDA
Viz.ai's cerebral aneurysms algorithm scores FDA clearance
By Laura Lovett | 02:36 pm | February 24, 2022
The technology will be included in the Viz Intelligent Care Coordination Platform. 
Abbott's implantable cardiac monitor CardioMEMS lands expanded FDA designation
By Laura Lovett | 01:19 pm | February 21, 2022
The system first landed clearance in 2014 for Class III heart failure patients. 
An older man wearing headphones checking his smartphone
Senseonics scores FDA approval for Eversense E3 CGM with implantable sensor
By Emily Olsen | 01:14 pm | February 14, 2022
The continuous glucose monitoring system can be used to measure glucose levels in adults with diabetes for up to six months.
AliveCor screen
AliveCor rolls out credit card-sized ECG
By Laura Lovett | 12:27 pm | February 01, 2022
The technology is able to take a single-lead ECG in 30 seconds. 
The Omnipod 5 system including the Dexcom G6 and the smartphone app
Insulet scores FDA greenlight for Omnipod 5 insulin delivery system
By Emily Olsen | 03:17 pm | January 31, 2022
The pump currently integrates with the Dexcom G6 CGM and can be worn for up to 72 hours.
A doctor showing a senior patient how to synchronize their health app in a smartphone and a smartwatch
Better than ever with a long way to go: The future of digital health reimbursement
By Emily Olsen | 01:11 pm | January 21, 2022
In a preview of their HIMSS22 presentation, Robert Jarrin, strategic advisor to ResMed Corp., and Brian Scarpelli, senior global policy counsel at the Connected Health Initiative, explain the current digital health reimbursement landscape.
A woman wearing a virtual reality headset
What's next for AppliedVR after its FDA De Novo
By Emily Olsen | 11:01 am | January 21, 2022
Cofounder and CEO Matthew Stoudt discusses AppliedVR's De Novo clearance from November, what's next for the company and the biggest trends from 2021.
A chest x-ray showing Qure.ai's technology for breathing tube placement
Qure.ai gets FDA green light for AI algorithm for breathing tube placement and other digital health briefs
By Emily Olsen | 02:33 pm | January 20, 2022
Also: Truepill launches a COVID-19 test coverage platform for insurers, and 23andMe extends its partnership with GSK.