Regulation

A woman using an AppliedVR headset at home
AppliedVR’s EaseVRx scores FDA De Novo clearance for treating chronic lower back pain
By Emily Olsen | 12:43 pm | November 17, 2021
The news comes about a week after AppliedVR announced it raised $36 million in Series B funding.
Clinicians look at screen
Royal Philips scores 510(k) for Liver Fat Quantification tool
By Laura Lovett | 12:42 pm | November 17, 2021
The tool will be part of the EPIQ Elite and Affiniti systems. 
A sick person looking at a thermometer
FDA classifies Ellume at-home COVID-19 test recall as ‘most serious’ type
By Emily Olsen | 02:14 pm | November 10, 2021
Ellume began recalling the tests last month for giving false positive results.
CMS increases price transparency rule penalties; Papa snags $150M in Series D funding
By HIMSS TV | 10:40 am | November 05, 2021
This week's top stories include the CMS ups penalties for hospitals ignoring the price transparency rule, the ATA and other groups ask Congress to safeguard telehealth for workers, and senior assistance company Papa raises $150 million in Series D funding.
A man using the Detect COVID-19 test
Detect scores EUA from FDA for at-home molecular COVID-19 test
By Emily Olsen | 03:20 pm | October 29, 2021
Detect uses an app to help users perform the test and interpret the results.
Doctor talks to patient
Northwestern spinout Sibel Health scores FDA clearance for patient monitoring system
By Laura Lovett | 04:14 pm | October 27, 2021
The system includes two sensors and a digital platform. 
VR child
Luminopia scores FDA De Novo for VR treatment for lazy eye
By Laura Lovett | 12:42 pm | October 21, 2021
The tool uses virtual reality to modify media content in order to help children boost their visual acuity. 
The SoftVue 3D Whole Breast Ultrasound Tomography System
Delphinus receives FDA clearance for ultrasound breast cancer screening tech
By Mallory Hackett | 12:55 pm | October 12, 2021
The SoftVue system is intended to be used in addition to digital mammograms to screen for cancer among patients with dense breast tissue.
Withings' ScanWatch
Withings scores FDA clearance for smartwatch ECG and SpO2 monitoring
By Laura Lovett | 12:42 pm | October 12, 2021
The ScanWatch was first unveiled in January 2020 and is currently on the European market. 
Juno, CQC, privacy, data governance, Forward Clinical
CQC inspection finds Juno app requires improvement
By Tammy Lovell | 03:22 am | October 11, 2021
The regulator’s report flagged governance issues in the midwifery and pediatrics service.