Shankar Somasundaram

The Underrated Variable of IoMT Device Security: Collaboration

By Shankar Somasundaram

…importantly, their patients. References: [i] “Healthcare cyberattacks led to worse patient care, increased mortality, study finds,” Healthcare Dive, September 8, 2023, https://www.healthcaredive.com/news/cyberattacks-hospitals-disrupt-operations-patient-care-Ponemon/631439/ [ii] [ii] “IBM: Average Cost of a Healthcare…

…importantly, their patients. References: [i] “Healthcare cyberattacks led to worse patient care, increased mortality, study finds,” Healthcare Dive, September 8, 2023, https://www.healthcaredive.com/news/cyberattacks-hospitals-disrupt-operations-patient-care-Ponemon/631439/ [ii] [ii] “IBM: Average Cost of a Healthcare…

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Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds

Sonio has received Regulatory Class II FDA 510(k) clearance for Sonio Detect, a manufacturer-agnostic software product that uses artificial intelligence (AI) to enhance the quality of fetal exams, and automatically…

Sonio has received Regulatory Class II FDA 510(k) clearance for Sonio Detect, a manufacturer-agnostic software product that uses artificial intelligence (AI) to enhance the quality of fetal exams, and automatically…

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FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization

By MedTech Intelligence Staff

In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health (CDRH) is taking additional steps…

In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health (CDRH) is taking additional steps…

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AdvaMed Warns EPA of Massive Interruption to Patient Care

By MedTech Intelligence Staff

In comments filed with the Environment Protection Agency (EPA), industry association AdvaMed called for continued cooperation between the medical device industry and the EPA as the regulations covering medical device…

In comments filed with the Environment Protection Agency (EPA), industry association AdvaMed called for continued cooperation between the medical device industry and the EPA as the regulations covering medical device…

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Cabonce and Ehman WuXi

The MDR Deadline Extension: Use the Time Wisely

By Kim Ehman, Ph.D., Mark Cabonce

…of April 2023) but is still only a fraction of what is needed to help manufacturers take this crucial regulatory step. Subscribe to the MedTech Intelligence weekly newsletter to stay…

…of April 2023) but is still only a fraction of what is needed to help manufacturers take this crucial regulatory step. Subscribe to the MedTech Intelligence weekly newsletter to stay…

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Boston Scientific Elects Dr. Jessica L. Mega and Susan E. Morano to Board of Directors

By MedTech Intelligence Staff

Jessica L. Mega, MD, and Susan E. Morano have joined the Boston Scientific Corporation board of directors. Jessica L. Mega, MD Dr. Mega is the co-founder of Verily Life Sciences,…

Jessica L. Mega, MD, and Susan E. Morano have joined the Boston Scientific Corporation board of directors. Jessica L. Mega, MD Dr. Mega is the co-founder of Verily Life Sciences,…

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Vik Anantha

Data-driven Surgery: The Next Step in Improving Care and Operational Efficiency

By Vik Anantha

…US News & World Report “honor roll” for best care, the networks they belonged to showed substantial variation in care.[6] A recent study on practice variation in JAMA Health Forum…

…US News & World Report “honor roll” for best care, the networks they belonged to showed substantial variation in care.[6] A recent study on practice variation in JAMA Health Forum…

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FDA Announces Additional Steps to Modernize Clinical Trials

By MedTech Intelligence Staff

On June 6, the FDA released E6(R3) Guideline for Good Clinical Practice, a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct…

On June 6, the FDA released E6(R3) Guideline for Good Clinical Practice, a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct…

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AAMI and BSI Partner to Publish Guidance on Artificial Intelligence

By MedTech Intelligence Staff

The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial…

The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial…

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