Devices

FDA Can Help CMS with Hospital Cybersecurity: OIG

The HHS Inspector General (IG) says FDA should be working with the Centers for Medicare and Medicaid Services (CMS) on cybersecurity for networked medical devices in hospitals. In an Issue Brief, the IG says that without proper cybersecurity controls, hospitals’ networked medical devices can be compromised, which can lead to patient harm.

The report says the CMS survey protocol for overseeing hospitals is silent on device cybersecurity. It recommends that CMS identify and implement an appropriate way to address cybersecurity of networked medical devices in its quality oversight of hospitals in consultation with HHS partners and others.

The report notes the IG previously examined FDA’s role in assessing the cybersecurity risk of medical devices in premarket and postmarket settings. A 2018 report found the agency had taken steps to address emerging cybersecurity concerns, including issuing guidances on medical device cybersecurity and reviewing cybersecurity information in premarket submissions for networked medical devices.

The IG says CMS should work with partners inside and outside HHS, including FDA, to determine the best method for addressing cybersecurity of networked medical devices in hospitals.

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