Devices

MDIC Forms 5G Healthcare Technology Working Group

The Medical Device Innovation Consortium (MDIC) says it has formed a Working Group, sought by FDA, focusing on 5G-enabled health technologies. MDIC says working group stakeholders are subject matter experts and senior-level executives from medical device manufacturers, 5G network operators, 5G chipset and network equipment manufacturers, wireless service providers, test laboratories and test equipment manufacturers, standard development organizations, academic research groups, and FDA.

Topics and activities envisioned by the working group are:

identifying medical device 5G use-cases and best practices for 5G integration;
outlining evaluation methods for the safe and effective use of 5G in medical devices;
incorporating telecommunication technology suppliers in the medical device supply chain; and
managing the relationship between the device manufacturer, network operators, and the end-user throughout the pre-market and post-market cycle.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome