Public Policy

Owlet pulls connected-sock wearables after FDA warning; TeamHealth wins lawsuit against UHC
By HIMSS TV | 09:35 am | December 03, 2021
This week's top stories include baby tech company Owlet pulling its connected-sock wearables following an FDA warning letter, and TeamHealth's victory in a lawsuit accusing UnitedHealthcare of engaging in unfair reimbursement practices.
A close up of a person holding a tablet
metaMe Health scores FDA 510(k) for digital tool treating IBS-related abdominal pain
By Emily Olsen | 02:18 pm | December 01, 2021
Regulora delivers behavioral therapy based on gut-directed hypnotherapy through a smartphone app.
An Oculus headset using InvisionOS
PrecisionOS receives FDA 510(k) approval for VR surgical planning tool
By Emily Olsen | 12:24 pm | November 30, 2021
The InVisionOS officially received the clearance earlier this month and will be available in early 2022.
FDA
Owlet pulls Smart Socks following FDA warning letter
By Laura Lovett | 02:24 pm | November 29, 2021
The stock took a tumble in October following the letter. 
Hands holding puzzle pieces
HIMSS21 Middle East: How can we better prepare for the next pandemic?
By Rosy Matheson | 06:30 pm | November 24, 2021
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.
An old-timey microphone and radio setup represent our weekly digital health podcast
HIMSSCast Industry Voices: Baking equity into healthcare business models
By MobiHealthNews | 11:57 am | November 19, 2021
Digital health movers and shakers weigh in on how the industry can make progress on building next-generation healthcare for everyone.
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.