Innovative Publishing Names Inga Hansen Managing Editor of MedTech Intelligence
Innovative Publishing names new face for MedTech Intelligence
FDA CDRH Announces Reopening for All IVD Pre-Submissions
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
MedAccred Program to Develop Labeling, Printing and UDI Audit Criteria Launched
“The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”
AHRQ Releases Technical Brief on Evaluation of Mental Health Apps
The AHRQ brief proposes a framework to assess the risk/safety, technical functionality and mental health features of apps. The framework can be used by advocacy organizations, payers, healthcare systems and others to inform selection of mental health mobile apps.
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.
Five Finalists of Annual Pediatric Medical Device Competition Announced
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap.”
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap.”
CDRH Releases Update on Actions Related to Philips Respironics 2021 Recall
The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.
Medtronic Recalls Harmony Delivery Catheter Due to Risk of Capsule Breakage During Use
The catheter is part of the company’s transcatheter pulmonary valve system.
Virtual Event Addresses Telemedicine and Healthcare Outside of the Hospital
The pandemic forced patients and providers to rely on telemedicine, a change that has had a significant impact on the course of care. Experts discuss what can be accomplished with virtual care and what this means for the potential of medical devices.
Risk of False Results with Certain Prenatal Genetic Screening Tests
FDA has issued a safety communication to alert patients and healthcare providers about the dangers of inappropriate use of NIPS tests.
