Russia, Ukraine flags

U.S. MedTech, Healthcare Companies Not Immune to Cyberthreats Amid Russia-Ukraine War

By MedTech Intelligence Staff

Although the war is happening on the other side of the globe, U.S healthcare systems are on high alert. Cyberattacks have been on the rise, and the Russia-Ukraine conflict has…

Although the war is happening on the other side of the globe, U.S healthcare systems are on high alert. Cyberattacks have been on the rise, and the Russia-Ukraine conflict has…

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FDA

Baxter Issues Urgent Safety Notification for Potential Alarm Malfunction in Infusion Pumps

By MedTech Intelligence Staff

Baxter International, Inc. issued an Urgent Safety Communication to reiterate critical information related to upstream occlusion alarms for its Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration setup and/or…

Baxter International, Inc. issued an Urgent Safety Communication to reiterate critical information related to upstream occlusion alarms for its Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration setup and/or…

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Lana Feng, Huma.AI

Artificial Intelligence Boosts New Era of Postmarket Intelligence

By Maria Fontanazza

The European regulatory landscape for medical devices has undergone considerable change over the past few years. Manufacturers continue to be challenged in the area of achieving (and understanding) compliance requirements,…

The European regulatory landscape for medical devices has undergone considerable change over the past few years. Manufacturers continue to be challenged in the area of achieving (and understanding) compliance requirements,…

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FDA

Senate Confirms Robert Califf as FDA Commissioner

By MedTech Intelligence Staff

…under consideration for the FDA commissioner position by the White House. She has served at FDA for 35 years. “Dr. Califf’s Senate confirmation is welcome news, and I congratulate him…

…under consideration for the FDA commissioner position by the White House. She has served at FDA for 35 years. “Dr. Califf’s Senate confirmation is welcome news, and I congratulate him…

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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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Coronavirus

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

By MedTech Intelligence Staff

Researchers at Rutgers New Jersey Medical School have developed a rapid test that can detect COVID-19 variants, and their study demonstrates that the test is 100% sensitive in identifying the…

Researchers at Rutgers New Jersey Medical School have developed a rapid test that can detect COVID-19 variants, and their study demonstrates that the test is 100% sensitive in identifying the…

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Medtronic

Medtronic Recalls Atherectomy System due to Risk of Catheter Breakage

By MedTech Intelligence Staff

Medtronic, Inc. has recalled its HawkOne Directional Atherectomy System due to the risk of catheter tip separation or breakage. The Class I recall affects more than 95,000 devices in the…

Medtronic, Inc. has recalled its HawkOne Directional Atherectomy System due to the risk of catheter tip separation or breakage. The Class I recall affects more than 95,000 devices in the…

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Justice scale, healthcare, cost

IBM Sells Watson Health to Private Investment Company

By MedTech Intelligence Staff

IBM announced that it is selling its healthcare data and analytics assets—part of Watson Health—to global investment company Francisco Partners. Financial details of the deal, which is expected to close…

IBM announced that it is selling its healthcare data and analytics assets—part of Watson Health—to global investment company Francisco Partners. Financial details of the deal, which is expected to close…

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Medtech, innovation

What Do BBQ Lighters and Microneedles Have in Common? An E-Patch for Improved Vaccine Delivery

By MedTech Intelligence Staff

Researchers from Georgia Tech and Emory University have developed an ePatch that could enable broader DNA vaccine deployment and simplify the process of delivering a vaccine—all at a lower cost….

Researchers from Georgia Tech and Emory University have developed an ePatch that could enable broader DNA vaccine deployment and simplify the process of delivering a vaccine—all at a lower cost….

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