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FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity

By MedTech Intelligence Staff

The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is soliciting input on how to enhance clinical study diversity. They will be hosting a two-day virtual public workshop…

The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is soliciting input on how to enhance clinical study diversity. They will be hosting a two-day virtual public workshop…

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Shankar Somasundaram

The Underrated Variable of IoMT Device Security: Collaboration

By Shankar Somasundaram

…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 Data Breach Increases to Almost $11 Million,” The HIPAA Journal, July 24, 2023, https://www.hipaajournal.com/2023-cost-healthcare-data-breach/…

…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 Data Breach Increases to Almost $11 Million,” The HIPAA Journal, July 24, 2023, https://www.hipaajournal.com/2023-cost-healthcare-data-breach/…

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Cally Edgren

Itā€™s Time for MedTech to Recognize PFAS Urgency

By Cally Edgren

…in the Stockholm Convention. https://chm.pops.int/TheConvention/ThePOPs/AllPOPs/tabid/2509/Default.aspx [3] Health and Safety Executive. (2023, March). Analysis of the most appropriate regulatory management options (RMOA). https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf [4] 3M. (n.d.). PFAS & Their Uses. https://pfas.3m.com/pfas_uses…

…in the Stockholm Convention. https://chm.pops.int/TheConvention/ThePOPs/AllPOPs/tabid/2509/Default.aspx [3] Health and Safety Executive. (2023, March). Analysis of the most appropriate regulatory management options (RMOA). https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf [4] 3M. (n.d.). PFAS & Their Uses. https://pfas.3m.com/pfas_uses…

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Sonio logo

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

…to quickly detect presence of heart and brain structures, and other important fetal imaging quality criteria. “We are deeply committed to advancing the field of prenatal health through innovation at…

…to quickly detect presence of heart and brain structures, and other important fetal imaging quality criteria. “We are deeply committed to advancing the field of prenatal health through innovation at…

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Priyanka Rawal
MEDdesign

The Promise and Potential Pitfalls of AI in Medical Device Design

By Priyanka Rawal

…for unintended purposes. Complex Regulatory Landscape. Compliance with various regulatory requirements and standards can be quite complex and time-consuming. It can be difficult for the regulatory bodies to ensure that…

…for unintended purposes. Complex Regulatory Landscape. Compliance with various regulatory requirements and standards can be quite complex and time-consuming. It can be difficult for the regulatory bodies to ensure that…

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

By MedTech Intelligence Staff

…to advance innovation in medical device sterilization. CDRH has updated its Recognized Consensus Standards database to include the complete recognition of one sterilization standard (ISO 22441:2022) and two Technical Information…

…to advance innovation in medical device sterilization. CDRH has updated its Recognized Consensus Standards database to include the complete recognition of one sterilization standard (ISO 22441:2022) and two Technical Information…

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Mindy Herman and Kristen Bednarczyk
Soapbox

The Expansion of IoMT Technology Requires Stringent Privacy Protections

By Kristen Bednarczyk, Mindy Herman

…at the core of life sciences companies. With transparency comes trust, and with trust comes retention. Companies can demonstrate transparency with patients by providing the details of who their data…

…at the core of life sciences companies. With transparency comes trust, and with trust comes retention. Companies can demonstrate transparency with patients by providing the details of who their data…

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Vishnu Kalra

Partnering to Support Sustainability in the OR

By MedTech Intelligence Staff

…all Industries. This is going to require everyone to come together—no one company will have all the answers. But this is where our industry plays at its best, in sharing…

…all Industries. This is going to require everyone to come together—no one company will have all the answers. But this is where our industry plays at its best, in sharing…

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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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