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Monday Morning Update 11/17/25

Monday Morning Update 11/17/25

November 16, 2025November 16, 2025
How genomics and AI are redefining Middle Eastern healthcare

How genomics and AI are redefining Middle Eastern healthcare

November 15, 2025November 15, 2025
The human factor in explainable artificial intelligence: clinician variability in trust, reliance, and performance

The human factor in explainable artificial intelligence: clinician variability in trust, reliance, and performance

November 15, 2025November 15, 2025
CHIME25: Data Governance and Interoperability Are Critical to AI Preparedness

CHIME25: Data Governance and Interoperability Are Critical to AI Preparedness

November 14, 2025November 15, 2025
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Tag: FDA Clearance

HeartFocus by DESKi Launches in U.S. on Butterfly Network Handheld Ultrasound

HeartFocus by DESKi Launches in U.S. on Butterfly Network Handheld Ultrasound

August 29, 2025August 29, 2025HIT Consultant

What You Should Know:

– HeartFocus, the revolutionary, AI-enabled cardiac imaging software developed by data-driven medtech company DESKi, today announced its U.S. commercial launch.

–   HeartFocus will initially be available on Butterfly Network’s handheld ultrasound devices, the FDA-cleared…

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Better Medicine Raises $7M to Commercialize AI-Powered Radiology Tools

Better Medicine Raises $7M to Commercialize AI-Powered Radiology Tools

August 14, 2025August 15, 2025HIT Consultant

What You Should Know: 

– Better Medicine, an AI-powered diagnostic startup for radiology, has secured nearly €6M ($6.89M) in total funding. The company recently raised €1M ($1.1M) in a pre-seed funding round led by Soulmates…

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DeepHealth Receives FDA Clearance for Remote Scanning Solution, TechLive™

DeepHealth Receives FDA Clearance for Remote Scanning Solution, TechLive™

August 7, 2025August 8, 2025HIT Consultant

What You Should Know: 

– DeepHealth, a subsidiary of RadNet, has received FDA 510(k) clearance for its new remote scanning solution, TechLive™. The vendor-agnostic platform is designed to address the growing radiology technologist shortage by…

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Build Smart, Not Fast: What the FDA Really Cares About in Digital Therapeutics

Build Smart, Not Fast: What the FDA Really Cares About in Digital Therapeutics

July 29, 2025July 29, 2025HIT Consultant

Justin Kozak, Executive VP at Founder Shield

Digital therapeutics (DTx) are revolutionizing healthcare — from smart inhalers to virtual therapy avatars. As more patients turn to DTx apps, companies rush to deliver innovative features. But in the race to…

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Aktiia gets FDA clearance for OTC cuffless blood pressure monitor

Aktiia gets FDA clearance for OTC cuffless blood pressure monitor

July 7, 2025July 7, 2025MobiHealthNews

Healthcare technology company Aktiia has received FDA 510(k) clearance for its over-the-counter cuffless blood pressure monitor, G0 Blood Pressure Monitoring System, also known as the Hilo Band. Aktiia’s blood pressure system, known under the Hilo…

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Fasikl's NeuroAI Wristband for essential tremor gains FDA clearance

Fasikl’s NeuroAI Wristband for essential tremor gains FDA clearance

July 3, 2025July 4, 2025MobiHealthNews

Minneapolis-based Fasikl has received FDA 510(k) clearance for its Felix NeuroAI Wristband for adults with essential tremor. The wearable combines AI and neurotechnology to modulate the nervous system to help alleviate functional limitations caused by…

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PathAI Granted FDA Clearance for AISight Dx for Primary Diagnosis in Clinical Settings

PathAI Granted FDA Clearance for AISight Dx for Primary Diagnosis in Clinical Settings

July 1, 2025July 1, 2025HIT Consultant

What You Should Know: 

– PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its digital…

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FDA clears Sora Neuroscience's brain mapping software

FDA clears Sora Neuroscience’s brain mapping software

June 27, 2025June 28, 2025MobiHealthNews

Sora Neuroscience, a brain AI software company, announced it received FDA clearance for its Cirrus brain mapping software, which is used for helping neurosurgeons make clinical decisions. Cirrus uses functional magnetic resonance imaging (fMRI) to generate…

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Hyperfine FDA Approves Revolutionary AI MRI Software

Hyperfine FDA Approves Revolutionary AI MRI Software

June 5, 2025June 5, 2025DistilINFO Hospital IT

Breakthrough AI Technology Transforms Portable Brain Imaging
Hyperfine Inc., the pioneering company behind the world’s first FDA-cleared AI-powered portable MRI system, has achieved another significant milestone with FDA clearance of its groundbreaking Optive AI software….

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Oura Ring now syncs with Dexcom’s Stelo CGM

Oura Ring now syncs with Dexcom’s Stelo CGM

May 7, 2025MobiHealthNews

Glucose monitoring specialist Dexcom is expanding its partnership with health-tracking ring maker Oura to provide Stelo users and ring wearers with metabolic health features, including meal insights and glucose data. Stelo provides individuals 18 and…

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The most promising technology is AI combined with what we call "digital endpoints" for each service we provide. Digital endpoints are technologies like online scheduling, asynchronous video visits, and voice and application programming interfaces. The combination of AI and these endpoints mean that we can enable more sophisticated navigation, new business models, reduce friction and improve care delivery.

Aaron Martin

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