Regulation

EU Health Technology Assessment, HTA, European Council, EU regulation
European Council gives the go-ahead to new healthtech assessment rules
By Tammy Lovell | 03:23 pm | November 23, 2021
The regulation will enable joint clinical assessments between EU member states.
Doctor listens to baby's heart
Cardiologs' cardiac diagnostic now cleared for kids
By Laura Lovett | 02:24 pm | November 22, 2021
This news comes just weeks after Philips announced its plans to acquire Cardiologs. 
A close-up of a person holding a tablet
Pear scores Breakthrough Device Designation for digital therapeutic aimed at alcohol use disorder
By Emily Olsen | 01:39 pm | November 22, 2021
The news comes just as Pear is finalizing its SPAC merger.
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.