FDA

Senate Confirms Robert Califf as FDA Commissioner

By MedTech Intelligence Staff

…emerges from the pandemic. We look forward to working with Commissioner Califf on our common goal of ensuring that the innovative medical technologies patients and providers rely on are safe…

…emerges from the pandemic. We look forward to working with Commissioner Califf on our common goal of ensuring that the innovative medical technologies patients and providers rely on are safe…

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Vidya Murthy, MedCrypt
MEDdesign

Changes in Healthcare Security Start with Better Device-Driven Security

By Vidya Murthy

A common adage in healthcare cybersecurity is that “people are the weakest link.” It is true in one sense—healthcare leads against other industries with 31% of cybersecurity related breaches being…

A common adage in healthcare cybersecurity is that “people are the weakest link.” It is true in one sense—healthcare leads against other industries with 31% of cybersecurity related breaches being…

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FDA

After Two Toddlers Die, FDA Issues Patient Communication for Enteral Feeding Delivery Sets

By MedTech Intelligence Staff

Today the FDA issued a Safety Communication alert to healthcare providers, parents and caregivers of pediatric patients who receive enteral feeding. The delivery sets use tubing that can become wrapped…

Today the FDA issued a Safety Communication alert to healthcare providers, parents and caregivers of pediatric patients who receive enteral feeding. The delivery sets use tubing that can become wrapped…

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FDA

FDA Resumes Domestic Surveillance Inspections

By MedTech Intelligence Staff

As a result in the decline in COVID-19 cases nationwide, FDA announced that it would resume conducting domestic surveillance inspections on February 7—affecting all commodities. The agency will continue with…

As a result in the decline in COVID-19 cases nationwide, FDA announced that it would resume conducting domestic surveillance inspections on February 7—affecting all commodities. The agency will continue with…

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Ajay Panwar, Medtronic
Soapbox

Potential for Artificial Intelligence in the Prevention and Detection of Cardiac Arrest

By Ajay Panwar

…the heart’s arteries. The arteries become apparent on X-ray and videotape as the dye fills them, exposing regions of obstruction. In addition, a nuclear scan, which is frequently combined with…

…the heart’s arteries. The arteries become apparent on X-ray and videotape as the dye fills them, exposing regions of obstruction. In addition, a nuclear scan, which is frequently combined with…

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Joris van der Heijden, StarFish Medical
MEDdesign

The Last Major Technical Hurdle for Personalized Medicine:  Manufacturability

By Joris van der Heijden, Ph.D.

…years to complete. Another recent initiative and success story is 64xBio, synthetic biology company that just landed a $55 million series-A financing round. 64x Bio is building a platform which…

…years to complete. Another recent initiative and success story is 64xBio, synthetic biology company that just landed a $55 million series-A financing round. 64x Bio is building a platform which…

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Healthcare Technology

Critical Issues in Remote Monitoring: Data Capture and Quality

By Jennifer Kent, Ph.D.

…status passively and are an alternative or complementary source of continuous monitoring, used in healthcare and in the active aging market. Some systems use a combination of smart home sensors…

…status passively and are an alternative or complementary source of continuous monitoring, used in healthcare and in the active aging market. Some systems use a combination of smart home sensors…

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Doug Folsom, TRIMEDX
Soapbox

The Evolution of Medical Device Cybersecurity Threats in the Wake of COVID-19

By Doug Folsom

…this environment is the security of medical devices, which are growing in number and complexity and are increasingly being connected to a network. The pandemic has further exposed the risk…

…this environment is the security of medical devices, which are growing in number and complexity and are increasingly being connected to a network. The pandemic has further exposed the risk…

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Coronavirus

Rutgers New Jersey Medical School Develops Rapid Test for COVID-19 Variants

By MedTech Intelligence Staff

…Health Research Institute in an ROI-NJ.com article . “We had recently improved an older version of the assay, so that it could detect the Delta variant, but, when Omicron appeared,…

…Health Research Institute in an ROI-NJ.com article . “We had recently improved an older version of the assay, so that it could detect the Delta variant, but, when Omicron appeared,…

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Medtronic

Medtronic Recalls Atherectomy System due to Risk of Catheter Breakage

By MedTech Intelligence Staff

…an arterial dissection or rupture, ischemia, and blood vessel complications that could lead to additional surgical procedures. Thus far, 163 complaints have been made about the device, with 55 injuries….

…an arterial dissection or rupture, ischemia, and blood vessel complications that could lead to additional surgical procedures. Thus far, 163 complaints have been made about the device, with 55 injuries….

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