SOTA

State-of-the-Art: Unpacking MDRā€™s Evolving Requirements

By Elisabeth Liljensten, Lina Burman, Mark Cabonce, M.S., DABT, Monica Grekula

…medical device manufacturing, alleviate subjective regulatory approvals and prioritize patient safety. To comply with EU legal requirements, any medical device on the market must be considered “state-of-the-art.” Therein lies the…

…medical device manufacturing, alleviate subjective regulatory approvals and prioritize patient safety. To comply with EU legal requirements, any medical device on the market must be considered “state-of-the-art.” Therein lies the…

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Blood pressure

Tonometry Superior for Cuffless Blood Pressure Monitoring

…The researchers found that tonometry-derived features showed superior performance compared to other feature groups and baselines, yielding prediction errors of 0.32±9.8 mmHg SBP and 0.54±7.7 mmHg DBP in-lab, and 0.86±8.7…

…The researchers found that tonometry-derived features showed superior performance compared to other feature groups and baselines, yielding prediction errors of 0.32±9.8 mmHg SBP and 0.54±7.7 mmHg DBP in-lab, and 0.86±8.7…

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Garrett Schumacher
MEDdesign

Velentium Launches Medical Device Cybersecurity Course with University of Colorado

…intelligence in relation to threat modeling. “Velentium is committed to educating the next generation of aspiring engineers and plans to expand this initiative to additional universities around the country, ultimately…

…intelligence in relation to threat modeling. “Velentium is committed to educating the next generation of aspiring engineers and plans to expand this initiative to additional universities around the country, ultimately…

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MilliporeSigma

Construction Begins on U.S.-based Lateral Flow Membrane Production Facility

By MedTech Intelligence Staff

…60 new jobs in Sheboygan, this new facility will provide a major step forward in expanding domestic diagnostic testing as the company’s first lateral flow membrane production facility in the…

…60 new jobs in Sheboygan, this new facility will provide a major step forward in expanding domestic diagnostic testing as the company’s first lateral flow membrane production facility in the…

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NIST Graphic

NIST Seeks Feedback on New Guidance for Healthcare Cybersecurity

By MedTech Intelligence Staff

…in the publication’s “Note to Reviewers,” which asks readers for thoughts on specific sections. NIST is accepting comments on the draft until Sept. 21, 2022 via email at: sp800-66-comments@nist.gov.  …

…in the publication’s “Note to Reviewers,” which asks readers for thoughts on specific sections. NIST is accepting comments on the draft until Sept. 21, 2022 via email at: sp800-66-comments@nist.gov.  …

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Brian Stallard, AAMI

Man vs. Machineā€”Or More of a Partnership?

By Brian Stallard

…place a chisel to best effect, no matter the mechanism that drives it home. But instead, by pitting them against one another, we lose man and machine alike. Machine, Meet…

…place a chisel to best effect, no matter the mechanism that drives it home. But instead, by pitting them against one another, we lose man and machine alike. Machine, Meet…

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Blood Pressure
Soapbox

IoMT and 5G Are Changing the Face of Healthcare Delivery

By Emily Newton

…at all times via a live stream. People participating in these tests said combining the 5G network and connected devices allowed them to provide faster patient care. The higher download

…at all times via a live stream. People participating in these tests said combining the 5G network and connected devices allowed them to provide faster patient care. The higher download

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FDA

FDA Issues Final Guidance on UDI Compliance Policy and Extends Enforcement Deadline

By MedTech Intelligence Staff

…“Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices,” was updated to clarify that…

…“Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices,” was updated to clarify that…

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DxD

Increasing Diversity in MedTech

By MedTech Intelligence Staff

…very hard to go back and change your company culture. Also, we know that these are the companies that the bigger companies are acquiring. If they purchase or invest in…

…very hard to go back and change your company culture. Also, we know that these are the companies that the bigger companies are acquiring. If they purchase or invest in…

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Jabil Team Photo

JABIL Cayey Receives MedAccred Plastics Injection Molding Accreditation

Puerto Rico-based Jabil Cayey has achieved MedAccred Accreditation for Plastics Injection Molding, meeting the audit requirements set by the subscribing member companies of the MedAccred program, including: Bausch Health, Baxter,…

Puerto Rico-based Jabil Cayey has achieved MedAccred Accreditation for Plastics Injection Molding, meeting the audit requirements set by the subscribing member companies of the MedAccred program, including: Bausch Health, Baxter,…

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