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UK Releases Draft Post Market Surveillance Requirements for Medical Devices

By MedTech Intelligence Staff

The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations…

The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations…

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FDA Seeks Input on At-Home Use Medical Technologies

By MedTech Intelligence Staff

The FDA Center for Devices and Radiological Health (CDRH) is seeking input from the medical device industry, the public, patient advocacy organizations, healthcare providers and clinical researchers on at-home use…

The FDA Center for Devices and Radiological Health (CDRH) is seeking input from the medical device industry, the public, patient advocacy organizations, healthcare providers and clinical researchers on at-home use…

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Mitigating Supply Chain Risks

On November 8-9, members of the Medtech community will gather in Washington, DC, for the MedTech Supply Chain Intelligence Summit. Hear from industry leaders and join in the discussion as…

On November 8-9, members of the Medtech community will gather in Washington, DC, for the MedTech Supply Chain Intelligence Summit. Hear from industry leaders and join in the discussion as…

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Final Guidance for Submission of Off-The-Shelf Software in Medical Devices

By MedTech Intelligence Staff

On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides…

On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides…

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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

…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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