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Monday Morning Update 6/9/25

Monday Morning Update 6/9/25

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Omada Health Soars in NASDAQ Debut, Signaling Digital Health IPO Rebound

Omada Health Soars in NASDAQ Debut, Signaling Digital Health IPO Rebound

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Artificial Intelligence–Based Mobile Phone Apps for Child Mental Health: Comprehensive Review and Content Analysis

Artificial Intelligence–Based Mobile Phone Apps for Child Mental Health: Comprehensive Review and Content Analysis

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Why Healthcare Organizations Should Consider Next-Generation Data Centers

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Tag: FDA Clearance

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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Nanox Imaging Receives FDA Clearance

Nanox Imaging Receives FDA Clearance

April 30, 2025DistilINFO Hospital IT

Revolutionary Digital Tomosynthesis System Approved
NANO-X IMAGING LTD has achieved a significant milestone with FDA 510(k) clearance for their innovative Nanox.ARC X multi-source digital tomosynthesis system. The approval process was remarkably swift, taking less than…

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Dexcom G7 15-Day CGM Receives FDA Clearance

Dexcom G7 15-Day CGM Receives FDA Clearance

April 25, 2025DistilINFO Hospital IT

Extended Wear CGM Innovation Redefines Diabetes Management
Dexcom has reached a significant milestone with FDA clearance for its G7 15-Day continuous glucose monitoring system for adults 18 and older. This next-generation device extends wear time…

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World’s First AI Lung Sound Suite: TytoCare Gets FDA Clearance for Rhonchi

World’s First AI Lung Sound Suite: TytoCare Gets FDA Clearance for Rhonchi

April 15, 2025HIT Consultant

TytoCare lung exam

What You Should Know: 

– TytoCare, a pioneering virtual care company dedicated to delivering accessible, high-quality primary care from the comfort of home announced the company has become the first in the world…

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Click Therapeutics Obtains FDA Authorization for First Prescription Digital Therapeutic for Migraine Prevention

Click Therapeutics Obtains FDA Authorization for First Prescription Digital Therapeutic for Migraine Prevention

April 15, 2025HIT Consultant

What You Should Know: 

– Click Therapeutics, Inc. (“Click”), a leader in the rapidly evolving field of prescription medical treatments, encompassing both prescription digital therapeutics (PDTs) and software-enhanced drug™ therapies has received FDA marketing authorization…

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Dexcom receives FDA clearance for G7 15 Day glucose monitoring system

Dexcom receives FDA clearance for G7 15 Day glucose monitoring system

April 14, 2025MobiHealthNews

Glucose monitoring specialist Dexcom announced it received FDA clearance for its G7 15 Day continuous glucose monitoring (CGM) system for people 18 and older with type 1, type 2 and gestational diabetes. G7 15 Day,…

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Sibel Health Rakes In $30M for Its Wearable-Based RPM Platform

Sibel Health Rakes In $30M for Its Wearable-Based RPM Platform

March 21, 2025MedCity News

Remote patient monitoring startup Sibel Health closed a $30 million Series C funding round on Thursday, bringing its total funding amount to $63 million.

The company — founded in 2018 as a spinout of Northwestern…

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Sibel Health secures $30M, seventh FDA clearance

Sibel Health secures $30M, seventh FDA clearance

March 20, 2025MobiHealthNews

Patient monitoring company Sibel Health, a spin-out of Northwestern University, closed a $30 million Series C equity financing round and received its seventh FDA clearance. Steele Foundation for Hope led the round with participation by…

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EpiWatch wins FDA clearance for Apple Watch seizure management app

EpiWatch wins FDA clearance for Apple Watch seizure management app

March 19, 2025MobiHealthNews

EpiWatch, the Apple Watch-based epilepsy management company spun out from Johns Hopkins, announced it received FDA 510(k) clearance for its continuous seizure monitor platform that utilizes the popular wearable to detect and alert for…

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The vaccine rollout process is a classic case study for successful projects requiring "people, process and technology." In this equation, the technology infrastructure of an electronic health record and network connectivity seem to be sufficient at most health systems and communities to support the cause. As a result, the most crucial elements to enable success is the project leadership and teamwork amongst all segments of the healthcare delivery system (people and process).

Michael Restuccia

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