FDA

AI-assisted cardiac ultrasound guidance software receives De Novo clearance
By Dave Muoio | 05:38 pm | February 07, 2020
Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.
MDClone's data platform enters Canada, Cityblock augments Tufts Health Plan program and more digital health news briefs
By Dave Muoio | 02:44 pm | February 05, 2020
Also: Proof of concept for a metabolite-monitoring wristwatch; Qynapse's 510(k) clearance.
Sony lands FDA clearance for NUCLeUS Operating Room
By Laura Lovett | 02:36 pm | February 03, 2020
The new system lets clinicians share or capture videos and images from the OR. 
Imprivata's latest acquisition, Apple's record-breaking Q4 and more digital health news briefs
By Dave Muoio | 02:16 pm | January 30, 2020
Also: FDA launches mobile-friendly HIV medication database; Gates Foundation grant will bring machine vision diagnostic tool to underserved regions.
Abbott's device-controlled deep brain stimulation system receives expanded indication for Parkinson's treatment
By Dave Muoio | 02:40 pm | January 27, 2020
The system may now be used to target patients' internal globus pallidus, a portion of the brain associated with Parkinson's disease symptoms.
FDA clears VivaLNK's ECG Sensor platform, SDK
By Laura Lovett | 04:16 pm | January 23, 2020
The latest platform provides developers and providers direct control over streaming health data. 
Verily Study Watch picks up new 510(k) for irregular pulse monitoring
By Dave Muoio | 12:13 pm | January 22, 2020
A newly published notice from the FDA suggests a new capability for the Alphabet subsidiary's clinical research wearable.
US FDA clears NuvoAir's connected spirometer device
By Dave Muoio | 04:18 pm | January 09, 2020
The Air Next is designed for patients with respiratory conditions such as asthma, COPD and cystic fibrosis.
Eko's ECG analysis algorithm gains Breakthrough Device status, Cigna to offer virtual behavioral health services via MDLive and more digital health news briefs
By Dave Muoio | 02:40 pm | December 19, 2019
Also: AWS' natural language processing service for medical text adds new a capability; NHS Trust to deploy Tyto Care's platform for home pediatric care.
Ultromics receives FDA clearance for its AI-powered decision support system
By Tammy Lovell | 03:08 am | November 18, 2019
EchoGo helps earlier detection of cardiovascular disease, enabling clinicians to improve patient care and outcomes.