Exclusive: Huma receives US FDA Class II clearance for SaMD platform
A Software-as-a-Medical-Device platform from Huma has received US Food and Drug Administration Class II clearance, boosting innovation in digital health.
AI and Analytics
NHS-backed Acurable to launch sleep apnoea testing device in the US
London-based medical device company Acurable is launching its AcuPebble device for Obstructive Sleep Apnoea (OSA) diagnosis in the US.
Digital Patient
Ultromics granted FDA Breakthrough Device Status
Ultromics has gained FDA Breakthrough Device Designation for its AI-powered EchoGo Amyloidosis platform, which is speeding up diagnosis.
AI and Analytics
HearO app uses AI to predict heart failure deterioration
The HearO app from Cordio Medical is set to expand into the UK this year, helping congestive heart failure patients identify deterioration through AI tech.
AI and Analytics
Industry news in brief
This Digital Health News industry roundup covers Maven Clinic’s acquisition of Naytal and Medwise.ai securing a £1m investment to scale up operations.
News
Industry news in brief
This Digital Health News industry roundup includes funding to trial gaming and AI tech to diagnose Alzheimer’s and accreditation for a clinical AI platform.
News
AI platform designed to help diagnose stroke gains US regulatory approval
A platform which uses artificial intelligence to help clinicians identify certain types of stroke has received approval from the US Food and Drug Administration (FDA).
AI and Analytics
Appropriate regulation
The regulation of healthcare apps emerged as a hot topic at the end of last year; and will be the subject of a lively discussion at the HANDI spring symposium that forms part of EHI’s Digital Health Festival. Lis Evenstad reports.
Feature
Med device regulation not fit for apps
Medical apps need a better safety assurance process, but applying the processes applied to the regulation of medical devices may not be the way forward, the HANDI Health Apps conference has been told.
News
NHS England moves to regulate apps
NHS England is working with the US Food and Drug Administration on a bilateral framework for regulations on mobile health apps.
News