FFRangio System

Medtronic To Acquire CathWorks

…the FFRangio System combines artificial intelligence (AI) and advanced computational science to obtain FFR values from routine angiograms (X-rays), eliminating the need for drug stimulation and invasive pressure wires. As…

…the FFRangio System combines artificial intelligence (AI) and advanced computational science to obtain FFR values from routine angiograms (X-rays), eliminating the need for drug stimulation and invasive pressure wires. As…

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Gary Manning Headshot
Soapbox

AI-Driven Continuous Remote Patient Monitoring (cRPM) Empowers Telehealth

By Gary Manning

complications and significant cost savings compared to traditional inpatient hospital care.[5] AI-Driven cRPM for Post-Acute Care Medical-grade cRPM assets utilizing artificial intelligence (AI) can collect and analyze wearable biosensor data…

complications and significant cost savings compared to traditional inpatient hospital care.[5] AI-Driven cRPM for Post-Acute Care Medical-grade cRPM assets utilizing artificial intelligence (AI) can collect and analyze wearable biosensor data…

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Harvard SEAS/Michael Rosnach

Harvard Bioengineers Develop Biohybrid Heart Ventricles

By MedTech Intelligence Staff

…was to build a model where we could test Sallin’s hypothesis and study the relative importance of the heart’s helical structure,” said John Zimmerman, a postdoctoral fellow at SEAS and…

…was to build a model where we could test Sallin’s hypothesis and study the relative importance of the heart’s helical structure,” said John Zimmerman, a postdoctoral fellow at SEAS and…

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Big Data

Addressing Data Challenges in MedTech

…collection, retention and analysis. Critical Data Challenges The following data challenges faced by many medical device companies can complicate their commercial analytics: Customer Data Levels: A medical device company has…

…collection, retention and analysis. Critical Data Challenges The following data challenges faced by many medical device companies can complicate their commercial analytics: Customer Data Levels: A medical device company has…

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FDA

FDA To Host Committee Meeting on Identification of Skin Lesions Using Computer-Aided DevicesĀ 

By MedTech Intelligence Staff

…to obtain additional information when considering biopsy. The committee will discuss if there is sufficient information to reclassify computer-aided devices for adjunctive diagnostic information of lesions suspicious for melanoma from…

…to obtain additional information when considering biopsy. The committee will discuss if there is sufficient information to reclassify computer-aided devices for adjunctive diagnostic information of lesions suspicious for melanoma from…

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Woman with Smartphone

HHS Issues Guidance on Patient Privacy and Tracking Apps in Wake of Supreme Court Decision

By MedTech Intelligence Staff

…Department of Health and Human Services (HHS) Secretary Xavier Becerra called on HHS agencies to take action to protect access to sexual and reproductive health care, including abortion, pregnancy complications,…

…Department of Health and Human Services (HHS) Secretary Xavier Becerra called on HHS agencies to take action to protect access to sexual and reproductive health care, including abortion, pregnancy complications,…

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European Union Flag

European Commission Adopts Common Specifications for High-Risk Diagnostics

On July 4, The European Commission adopted common specifications for several types of high-risk diagnostics. The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal…

On July 4, The European Commission adopted common specifications for several types of high-risk diagnostics. The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal…

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Dan Golder, Impact Advisors
Soapbox

Next-Generation Enterprise Asset Management

By Daniel Golder, DDS, MBA

Historically, Enterprise Asset Management (EAM) systems evolved to help solve the transactional challenges associated with equipment provisioning, maintenance, resource scheduling and regulatory compliance. The earliest systems (termed CMMS or “Computerized…

Historically, Enterprise Asset Management (EAM) systems evolved to help solve the transactional challenges associated with equipment provisioning, maintenance, resource scheduling and regulatory compliance. The earliest systems (termed CMMS or “Computerized…

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Regulations

MHRA Responds to Trade Association Concerns with Transitional Guidance

By MedTech Intelligence Staff

…be complied with for all products which benefit from the transitionary arrangements For general medical devices and IVDs that hold a valid certification/declaration of conformity to the UKCA standard before…

…be complied with for all products which benefit from the transitionary arrangements For general medical devices and IVDs that hold a valid certification/declaration of conformity to the UKCA standard before…

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John Mastrototaro

Next Steps in Wearables

By MedTech Intelligence Staff

comfort. What do providers want from these devices? Mastrototaro: Historically, providers have been a little bit wary of wearables. The fear is that people are going to come to them…

comfort. What do providers want from these devices? Mastrototaro: Historically, providers have been a little bit wary of wearables. The fear is that people are going to come to them…

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