FDA Issues Final Guidance on Technical Performance Assessments of Quantitative Imaging in Premarket Submissions

By MedTech Intelligence Staff

On June 16, the FDA released its final guidance for industry and FDA staff on Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions. The guidance document clarifies…

On June 16, the FDA released its final guidance for industry and FDA staff on Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions. The guidance document clarifies…

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Hand holding globe - diversity

AdvaMed Releases New Resource on Diversity in Clinical Research

The Advanced Medical Technology Association (AdvaMed) has released “Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities”, a new document intended to outline considerations and approaches to improving…

The Advanced Medical Technology Association (AdvaMed) has released “Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities”, a new document intended to outline considerations and approaches to improving…

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Inga Hansen, Managing Editor

Innovative Publishing Names Inga Hansen Managing Editor of MedTech Intelligence

…and connect Medical Device, Diagnostic, Digital Health and Regulatory organizations with original in-depth features and reports, curated industry news and user-contributed content, and live and virtual conferences that offer knowledge,…

…and connect Medical Device, Diagnostic, Digital Health and Regulatory organizations with original in-depth features and reports, curated industry news and user-contributed content, and live and virtual conferences that offer knowledge,…

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FDA CDRH Announces Reopening for All IVD Pre-Submissions

By MedTech Intelligence Staff

On May 31, the FDA Center for Devices and Radiological Health (CDRH) announced that, as of June 1, 2022, CDRH plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions….

On May 31, the FDA Center for Devices and Radiological Health (CDRH) announced that, as of June 1, 2022, CDRH plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions….

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Device Labeling MedAccred

MedAccred Program to Develop Labeling, Printing and UDI Audit Criteria Launched

By MedTech Intelligence Staff

Leading medical device original equipment manufacturers (OEMs) have launched a new MedAccred critical process focus area for Labeling, Printing, and Unique Device Identifier (UDI). The goal of the new program…

Leading medical device original equipment manufacturers (OEMs) have launched a new MedAccred critical process focus area for Labeling, Printing, and Unique Device Identifier (UDI). The goal of the new program…

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Mobile apps

AHRQ Releases Technical Brief on Evaluation of Mental Health Apps

By MedTech Intelligence Staff

The Department of Health and Human Resources, Agency for Healthcare Research and Quality (AHRQ) has released a technical brief on the evaluation of mental health apps. The agency worked with…

The Department of Health and Human Resources, Agency for Healthcare Research and Quality (AHRQ) has released a technical brief on the evaluation of mental health apps. The agency worked with…

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Leslie Trigg Outset Medical

Outset Medical CEO Elected MDMA Board Chair

Leslie Trigg, CEO of Outset Medical, is the new Chair of The Medical Device Manufacturers Association (MDMA) Board of Directors. Trigg follows the three-year tenure of Jeff McCaulley, CEO of…

Leslie Trigg, CEO of Outset Medical, is the new Chair of The Medical Device Manufacturers Association (MDMA) Board of Directors. Trigg follows the three-year tenure of Jeff McCaulley, CEO of…

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Five Finalists of Annual Pediatric Medical Device Competition Announced

Five finalists have been named in the annual “Make Your Medical Device Pitch for Kids!” competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in…

Five finalists have been named in the annual “Make Your Medical Device Pitch for Kids!” competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in…

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FDA

CDRH Releases Update on Actions Related to Philips Respironics 2021 Recall

By MedTech Intelligence Staff

In June 2021, Philips Respironics issued a voluntary recall for specific ventilators, bi-level positive airway pressure and continuous positive airway pressure machines due to device breakage that could lead to…

In June 2021, Philips Respironics issued a voluntary recall for specific ventilators, bi-level positive airway pressure and continuous positive airway pressure machines due to device breakage that could lead to…

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Alert

Medtronic Recalls Harmony Delivery Catheter Due to Risk of Capsule Breakage During Use

By MedTech Intelligence Staff

Medtronic is recalling its Harmony Delivery Catheter System, which is part of the Harmony Transcatheter Pulmonary Valve (TPV) System due to the risk of breakage during placement of the TPV….

Medtronic is recalling its Harmony Delivery Catheter System, which is part of the Harmony Transcatheter Pulmonary Valve (TPV) System due to the risk of breakage during placement of the TPV….

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