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Innovative approach is key for early-stage startups

Innovative approach is key for early-stage startups

December 6, 2025December 6, 2025
Integrate EMS data into hospital systems to enhance ED operations

Integrate EMS data into hospital systems to enhance ED operations

December 5, 2025December 6, 2025
Transparency Trap: Why Commercial Negotiated Hospital Rates Are Up to 32% Higher Than Cash Prices

Transparency Trap: Why Commercial Negotiated Hospital Rates Are Up to 32% Higher Than Cash Prices

December 5, 2025December 6, 2025
$32.9M Investment: UArizona and Onvida Health Launch Rural Medical Branch to Solve Arizona’s Primary Care Crisis

$32.9M Investment: UArizona and Onvida Health Launch Rural Medical Branch to Solve Arizona’s Primary Care Crisis

December 5, 2025December 6, 2025
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Tag: FDA clearance 510k

11 Recent Digital Health FDA Clearances You Need to Know: AI, Wearables, and Robotics Drive Precision Medicine Forward

11 Recent Digital Health FDA Clearances You Need to Know: AI, Wearables, and Robotics Drive Precision Medicine Forward

November 21, 2025November 22, 2025HIT Consultant

What You Should Know:

– The U.S. Food and Drug Administration (FDA) has recently issued several key clearances, marking significant advancements across diagnostics, surgery, and remote patient monitoring.

– These FDA clearances reflect a deepening integration…

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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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Withings Sleep Rx Receives FDA Clearance for Home Sleep Apnea Testing

Withings Sleep Rx Receives FDA Clearance for Home Sleep Apnea Testing

September 9, 2024September 10, 2024HIT Consultant

What You Should Know: 

– Withings, a global leader in connected health, has announced that its Sleep Rx sleep apnea device has received clearance from the U.S. Food and Drug Administration (FDA). 

– Sleep Rx represents…

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Philips IntelliSite Pathology Solution Receives 510(k) Clearance

Philips IntelliSite Pathology Solution Receives 510(k) Clearance

July 12, 2024July 12, 2024HIT Consultant

What You Should Know:  – Philips IntelliSite Pathology 5.1 has received 510(k) clearance from the FDA, solidifying its position as the most widely deployed digital pathology solution for primary diagnosis globally.  – With over…

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WearLinq Acquires AMI Cardiac Monitoring, Raises $6.7M for FDA 510(k) Cleared 6-Lead ECG Device

WearLinq Acquires AMI Cardiac Monitoring, Raises $6.7M for FDA 510(k) Cleared 6-Lead ECG Device

May 21, 2024May 22, 2024HIT Consultant

What You Should Know: 

– WearLinq, a leader in wearable health monitoring, announced a strategic acquisition of AMI Cardiac Monitoring, LLC, a seasoned player in ambulatory cardiac monitoring. 

– The acquisition, coupled with a recent $6.7M…

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Implicity Launches FDA-approved Heart Failure Prediction Algorithm, SignalHF

Implicity Launches FDA-approved Heart Failure Prediction Algorithm, SignalHF

May 17, 2024May 17, 2024HIT Consultant

What You Should Know: 

– Implicity, a leader in remote patient monitoring and cardiac data management, has received FDA 510(k) clearance for SignalHF1, a groundbreaking new algorithm within their remote monitoring solution. 

– SignalHF1 algorithm empowers…

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AI Breakthrough for Lung Disease: Thirona's LungQ Receives FDA Clearance

AI Breakthrough for Lung Disease: Thirona’s LungQ Receives FDA Clearance

January 23, 2024January 23, 2024HIT Consultant

What You Should Know:

– Thirona, a pioneer in AI-powered lung analysis, received a major boost for its cutting-edge technology LungQ™ with the U.S. Food and Drug Administration (FDA) 510(k) clearance for its latest update,…

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RapidAI Receives FDA Clearance for Rapid SDH for Trauma Care

RapidAI Receives FDA Clearance for Rapid SDH for Trauma Care

November 10, 2023November 11, 2023HIT Consultant

What You Should Know: – RapidAI has received FDA clearance for Rapid SDH, its AI-powered module for the detection and notification of suspected hemispheric acute and chronic subdural hematoma. – The need for the…

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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

Recent Posts

  • Innovative approach is key for early-stage startups

    Innovative approach is key for early-stage startups

    December 6, 2025December 6, 2025Comments Off on Innovative approach is key for early-stage startups
  • Integrate EMS data into hospital systems to enhance ED operations

    Integrate EMS data into hospital systems to enhance ED operations

    December 5, 2025December 6, 2025Comments Off on Integrate EMS data into hospital systems to enhance ED operations
  • Transparency Trap: Why Commercial Negotiated Hospital Rates Are Up to 32% Higher Than Cash Prices

    Transparency Trap: Why Commercial Negotiated Hospital Rates Are Up to 32% Higher Than Cash Prices

    December 5, 2025December 6, 2025Comments Off on Transparency Trap: Why Commercial Negotiated Hospital Rates Are Up to 32% Higher Than Cash Prices
  • $32.9M Investment: UArizona and Onvida Health Launch Rural Medical Branch to Solve Arizona’s Primary Care Crisis

    $32.9M Investment: UArizona and Onvida Health Launch Rural Medical Branch to Solve Arizona’s Primary Care Crisis

    December 5, 2025December 6, 2025Comments Off on $32.9M Investment: UArizona and Onvida Health Launch Rural Medical Branch to Solve Arizona’s Primary Care Crisis
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    Artera secures $65M and more digital health funding news

    December 5, 2025December 6, 2025Comments Off on Artera secures $65M and more digital health funding news
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    “Behind every document, there’s a patient in need of care.”

    December 5, 2025December 6, 2025Comments Off on “Behind every document, there’s a patient in need of care.”
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  • If a therapy bot walks like a duck and talks like a duck then it is a medically regulated duck

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    December 5, 2025December 6, 2025Comments Off on If a therapy bot walks like a duck and talks like a duck then it is a medically regulated duck
  • African digital health strategic plans analysis: key weaknesses in contextualization, intervention focus, and technological foresight

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