WHO logo

WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight 

By MedTech Intelligence Staff

…and diagnostic tests. Complimentary efforts—such as to strengthen regulatory and ethics oversight—are also considered. “This list of priority pathogens has become a reference point for the research community on where…

…and diagnostic tests. Complimentary efforts—such as to strengthen regulatory and ethics oversight—are also considered. “This list of priority pathogens has become a reference point for the research community on where…

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Medical device recall

Baxter Recalls WatchCare IMS Due to Risk of Interference with Nearby Medical Equipment 

By MedTech Intelligence Staff

for Centrella Bed (Distribution Dates: August 1, 2018 to September 1, 2022) The company initiated the recall after receiving reports that the RF from the devices may interfere with other…

for Centrella Bed (Distribution Dates: August 1, 2018 to September 1, 2022) The company initiated the recall after receiving reports that the RF from the devices may interfere with other…

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Trenholm Ninestein
Soapbox

How Health Tech Can Combat the High Cost of Lifestyle Choices

By Trenholm Ninestein

…to prevent injuries. Consider the possibilities of a video library that contains everything from warm-up stretching exercises to yoga for seniors. Communications with Family/Caregivers One of the most compelling reasons…

…to prevent injuries. Consider the possibilities of a video library that contains everything from warm-up stretching exercises to yoga for seniors. Communications with Family/Caregivers One of the most compelling reasons…

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Drs. Melak and Heilman

Tufts Neurosurgeons Honored for Innovation in Hydrocephalus Treatment

By MedTech Intelligence Staff

…device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. They developed the company’s flagship product, the eShunt System, which includes an endovascularly implantable…

…device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. They developed the company’s flagship product, the eShunt System, which includes an endovascularly implantable…

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Anthony Fernando

From Art to Science:  How Machine Learning Is Changing the Surgical Landscape

By MedTech Intelligence Staff

…professionals? Fernando: There are two components to the device: The Senhance system is the robotic component, which includes the robotic manipulation and instrument manipulation. Then there is a complementary part,…

…professionals? Fernando: There are two components to the device: The Senhance system is the robotic component, which includes the robotic manipulation and instrument manipulation. Then there is a complementary part,…

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Elizabeth Holmes

Theranos Founder Sentenced to 11 Years in Prison

By MedTech Intelligence Staff

…in January on three counts of investor fraud and one count of conspiracy to commit fraud related to her blood-testing startup, faced up to 20 years in prison for each…

…in January on three counts of investor fraud and one count of conspiracy to commit fraud related to her blood-testing startup, faced up to 20 years in prison for each…

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FDA

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The…

The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The…

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Sean Hägen
MEDdesign

Why Human Factors Engineering Matters in Medical Device Packaging

By Sean Hägen

component in determining how that device will be packaged safely and efficiently for all targeted end-users and validated by regulatory authorities. Packaging and Labeling Are a Regulatory Focus From the…

component in determining how that device will be packaged safely and efficiently for all targeted end-users and validated by regulatory authorities. Packaging and Labeling Are a Regulatory Focus From the…

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AMA Logo

AMA Releases Blueprint for Optimizing Digitally Enabled Care

By MedTech Intelligence Staff

…to contribute to the full optimization of digitally enabled care and includes case examples featuring organizations with care models that leverage the blueprint’s six pillars. Opportunities for stakeholders include: Physicians:…

…to contribute to the full optimization of digitally enabled care and includes case examples featuring organizations with care models that leverage the blueprint’s six pillars. Opportunities for stakeholders include: Physicians:…

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FDA

FDA CDRH Releases Proposed Guidances for 2023

By MedTech Intelligence Staff

…it intends to publish, and a “B-List” of documents it intends to publish as resources permit. In the coming year, the FDA will also reopen for comment select final guidance…

…it intends to publish, and a “B-List” of documents it intends to publish as resources permit. In the coming year, the FDA will also reopen for comment select final guidance…

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