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Healthcare leaders reveal 2025’s biggest surprises, part two

Healthcare leaders reveal 2025’s biggest surprises, part two

December 16, 2025December 16, 2025
Good news and bad news for RPM in 2026

Good news and bad news for RPM in 2026

December 16, 2025December 16, 2025
WellSky and uMed expand home-based clinical trial access nationwide

WellSky and uMed expand home-based clinical trial access nationwide

December 16, 2025December 16, 2025
Catalyzing trust through interoperability: compliance as assurance

Catalyzing trust through interoperability: compliance as assurance

December 16, 2025December 16, 2025
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Tag: Software As A Medical Device

Yagua Health partners with blueBriX to digitise patient health records

Yagua Health partners with blueBriX to digitise patient health records

June 26, 2023June 26, 2023Digital Health

Low code no code digital health platform blueBriX has teamed up with Aruba’s leading private medical provider group Yagua Health to digitise the latter’s patient health records and improve patient experience.Yagua Health intends to…

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Roundup: South Korean AI software for sepsis detection gets US FDA nod and more briefs

Roundup: South Korean AI software for sepsis detection gets US FDA nod and more briefs

June 23, 2023June 24, 2023MobiHealthNews

SpassMed scores US FDA 510(k) for AI sepsis detection softwareSouth Korean medical AI company SpassMed has received the United States Food and Drug Administration’s 510(k) clearance for its AI-powered sepsis detection software. 
The AI solution…

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Huma receives 510(k) Class II clearance for its disease-agnostic platform

Huma receives 510(k) Class II clearance for its disease-agnostic platform

June 13, 2023June 14, 2023MobiHealthNews

UK-based digital health tech company Huma has received FDA 510(k) Class II clearance for its configurable disease-agnostic Software as a Medical Device platform, which includes the company’s cardiovascular risk score algorithm. The company, which received…

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Exclusive: Huma receives US FDA Class II clearance for SaMD platform

Exclusive: Huma receives US FDA Class II clearance for SaMD platform

June 12, 2023June 12, 2023Digital Health

Huma Therapeutics has received US Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software-as-a-Medical-Device (SaMD) platform, enabling companies to launch their own algorithm innovations more quickly to the platform and allowing…

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blueBriX digital health platform expands into pharmaceutical sector

blueBriX digital health platform expands into pharmaceutical sector

May 24, 2023May 25, 2023Digital Health

Digital health platform blueBriX has expanded into the pharmaceutical sector, enabling pharma to leverage software as a medical device (SaMD)-compliant solution to improve patient experience and drive revenue growth.blueBriX has been designed to provide…

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Aiming for Health Equity

Aiming for Health Equity

April 24, 2023April 24, 2023Healthcare IT Today

The following is a guest article by Hakim Yadi, PhD OBE, Co-Founder and CEO at Closed Loop Medicine
Healthcare has historically taken a ‘one size fits all’ approach, which misses the ability to treat all…

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The Times They are a-Changin’– So are the FDA Rules on AI

The Times They are a-Changin’– So are the FDA Rules on AI

April 19, 2023April 20, 2023Digital Health Frontier

The agency recently posted new recommendations for AI developers who want to update their software as a medical device (SAMD). The document offers what we hope will be a less burdensome way to manage…

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You have to understand what are they worried about, what are their fears, what are they trying to do? If we don’t engage with them that way, it doesn’t matter what technology we use.

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Recent Posts

  • Healthcare leaders reveal 2025’s biggest surprises, part two

    Healthcare leaders reveal 2025’s biggest surprises, part two

    December 16, 2025December 16, 2025Comments Off on Healthcare leaders reveal 2025’s biggest surprises, part two
  • Good news and bad news for RPM in 2026

    Good news and bad news for RPM in 2026

    December 16, 2025December 16, 2025Comments Off on Good news and bad news for RPM in 2026
  • WellSky and uMed expand home-based clinical trial access nationwide

    WellSky and uMed expand home-based clinical trial access nationwide

    December 16, 2025December 16, 2025Comments Off on WellSky and uMed expand home-based clinical trial access nationwide
  • Catalyzing trust through interoperability: compliance as assurance

    Catalyzing trust through interoperability: compliance as assurance

    December 16, 2025December 16, 2025Comments Off on Catalyzing trust through interoperability: compliance as assurance
  • Mass General Brigham Spins Out AIwithCare: New AI Tool Doubles Clinical Trial Enrollment Rates

    Mass General Brigham Spins Out AIwithCare: New AI Tool Doubles Clinical Trial Enrollment Rates

    December 16, 2025December 17, 2025Comments Off on Mass General Brigham Spins Out AIwithCare: New AI Tool Doubles Clinical Trial Enrollment Rates
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    Infinitus Systems Launches Next-Gen ”Agentic” Clinical AI for Patient Conversations

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  • Ritten Raises $35M to Scale AI-Powered Behavioral Health Platform

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    December 16, 2025December 17, 2025Comments Off on Ritten Raises $35M to Scale AI-Powered Behavioral Health Platform
  • New York awards hospitals more than $300M for IT and cyber investments

    New York awards hospitals more than $300M for IT and cyber investments

    December 16, 2025December 17, 2025Comments Off on New York awards hospitals more than $300M for IT and cyber investments
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    First stages announced for Digital Health Rewired 2026

    December 16, 2025December 17, 2025Comments Off on First stages announced for Digital Health Rewired 2026
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    2026 Healthcare Executive Predictions: Why the AI “Pilot Era” Is Officially Over

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