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Product Design & Development

Cybersecurity, healthcare
February 10, 2021
Cybersecurity, healthcare

More Cyberattacks in Healthcare, Yet Most MedTech Leaders Unprepared, Says Survey

By MedTech Intelligence Staff
No Comments

A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.

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Sam Alnajjar, M.D.
February 9, 2021
Sam Alnajjar, M.D.
MEDdesign

Strategic National Stockpile Ventilators Can Support ‘Most’ Patients, but That Is Not Enough

By Sam Alnajjar, M.D.
No Comments

Critical care hasn’t had many breakthroughs in recent years and in order to change that, I believe we need to put more of an emphasis on integrating technology—specifically artificial intelligence (AI) —into the field.

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Kevin Fu, University of Michigan
February 4, 2021
Kevin Fu, University of Michigan

FDA Names Acting Director of Medical Device Cybersecurity

By MedTech Intelligence Staff
No Comments

The agency created the new post within CDRH, effective January 1.

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Alert
January 29, 2021
Alert

COVID-19 Introduces New Risks, Hazards in Health Tech

By MedTech Intelligence Staff
No Comments

With the accelerated adoption of many new technologies, ECRI’s annual health technology hazards list has been transformed by the COVID-19 pandemic.

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Romuald Braun, Amplexor
January 27, 2021
Romuald Braun, Amplexor
Soapbox

Regulatory Information Management Streamlines Processes and Supports Data Quality

By Romuald Braun
No Comments

Data integration is doing much to enhance regulatory information management. Life sciences companies are increasingly discovering useful interdependencies between data, documents and RIM processes. The next step is to put this data to work to improve efficiency.

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January 21, 2021
MEDdesign

Avoiding FDA Enforcement Actions: Understanding Quality Systems

By Amy Scanlin
No Comments

The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.

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Janet Woodcock, M.D., FDA
January 20, 2021
Janet Woodcock, M.D., FDA

CDER Director Janet Woodcock to Serve as Interim FDA Commissioner

By MedTech Intelligence Staff
No Comments

Woodcock was selected by outgoing Commissioner Stephen Hahn, M.D.

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Philip Adamson, M.D., Abbott
January 20, 2021
Philip Adamson, M.D., Abbott
MEDdesign

Remote Monitoring: Shaping Heart Failure Treatment in 2021 and Beyond

By Philip B. Adamson, M.D.
No Comments

Physicians are looking for better ways to treat patients with congestive heart failure. This includes the integration of remote monitoring and novel technologies.

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Medtech, innovation
January 15, 2021
Medtech, innovation

FDA: COVID-19 Put Spotlight on Digitization of Healthcare, and Importance of Data, Communication and Collaboration

By Maria Fontanazza
No Comments

During this week’s Consumer Electronics Show, FDA Principal Deputy Commissioner Amy Abernathy talks about lessons learned from the pandemic and 2021 goals.

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Abbott
January 13, 2021
Abbott

Abbott’s Virus Hunters Saw COVID Coming, Developed Three Molecular Tests in 30 Days

By Maria Fontanazza
No Comments

During a session at this week’s Consumer Electronics Show, Andrea Wainer, EVP of Rapid Molecular Diagnostics at Abbott, shares how the company scaled up to supply the global market with more than 300 million COVID-19 tests in 2020 and the path forward.

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