FDA

FDA’s Final Guidance Pushes Companies to be Recall Ready

By MedTech Intelligence Staff

In an effort to help companies be more recall ready, the FDA has finalized a guidance document that reviews how companies should have proper product coding and keep distribution records…

In an effort to help companies be more recall ready, the FDA has finalized a guidance document that reviews how companies should have proper product coding and keep distribution records…

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Jiayan Chen, McDermott Will & Emery
Soapbox

Disruptive Digital Health Models: Improving Access, Eliminating Bias and Delivering Higher Quality Care

By Jiayan Chen

…quality comes into conflict with cost-cutting—particularly in healthcare services that are becoming increasingly commodified—the profitability imperative too often takes priority. New digital health models can help prevent this type of…

…quality comes into conflict with cost-cutting—particularly in healthcare services that are becoming increasingly commodified—the profitability imperative too often takes priority. New digital health models can help prevent this type of…

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Russia, Ukraine flags

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

By MedTech Intelligence Staff

…week, the CISA-FBI joint advisory, “Destructive Malware Targeting Organizations in Ukraine” describes malware (WhisperGate and HermeticGate) that is targeting organizations in Ukraine and aims to destroy computer systems and render…

…week, the CISA-FBI joint advisory, “Destructive Malware Targeting Organizations in Ukraine” describes malware (WhisperGate and HermeticGate) that is targeting organizations in Ukraine and aims to destroy computer systems and render…

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Melinda Cisneros, Windstream Enterprise
MEDdesign

Neutralizing the Healthcare Industry’s Biggest Cyberthreats

By Melinda Cisneros

…has hit medical and healthcare companies—and their customers and patients—especially hard. Cyberattacks have escalated across the healthcare industry during the pandemic, further destabilizing already stressed companies (and their customers/patients). Citing…

…has hit medical and healthcare companies—and their customers and patients—especially hard. Cyberattacks have escalated across the healthcare industry during the pandemic, further destabilizing already stressed companies (and their customers/patients). Citing…

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Rachel Shelly, IDA Ireland
MEDdesign

Collaboration is Critical for Pushing Medtech Forward

By Rachel Shelly

…establish a new cancer research center that aims to use digital technologies for cancer treatment in Ireland. Located at University Hospital Limerick, research at the new Limerick Digital Cancer Research

…establish a new cancer research center that aims to use digital technologies for cancer treatment in Ireland. Located at University Hospital Limerick, research at the new Limerick Digital Cancer Research

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FDA

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

By MedTech Intelligence Staff

…being infused, volume and rate of infusion, and the patient’s underlying status and comorbidities,” Baxter stated in its company announcement, which was posted on the FDA website. Thus far, the…

…being infused, volume and rate of infusion, and the patient’s underlying status and comorbidities,” Baxter stated in its company announcement, which was posted on the FDA website. Thus far, the…

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Lana Feng, Huma.AI

Artificial Intelligence Boosts New Era of Postmarket Intelligence

By Maria Fontanazza

…than the competitors. This is a very daunting task. If you take literature search as an example, you have to manually go through hundreds sometimes thousands of publications from keyword…

…than the competitors. This is a very daunting task. If you take literature search as an example, you have to manually go through hundreds sometimes thousands of publications from keyword…

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Brian Stallard, AAMI
MEDdesign

Setting the Stage for the Next Generation of Medical Devices

By Brian Stallard

…innovation in the medical device space driving forward, some experts have posited on a future where medical system components can be seamlessly combined using common communication networks. Instead of functioning…

…innovation in the medical device space driving forward, some experts have posited on a future where medical system components can be seamlessly combined using common communication networks. Instead of functioning…

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FDA

Senate Confirms Robert Califf as FDA Commissioner

By MedTech Intelligence Staff

In a 50-46 vote, the U.S. Senate confirmed Robert Califf, M.D. as the new FDA commissioner. The close vote is reflective of the controversy that has followed Califf, who previously…

In a 50-46 vote, the U.S. Senate confirmed Robert Califf, M.D. as the new FDA commissioner. The close vote is reflective of the controversy that has followed Califf, who previously…

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The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

By Huma.AI

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision…

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision…

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