Devices

Cyber Threats to CareFusion Pyxis System

The Department of Homeland Security says that independent researchers in collaboration with CareFusion have identified numerous third-party software vulnerabilities in end-of-life versions of the company’s Pyxis SupplyStation system. Because the affected software versions are at end-of-life, the notice says, a patch will not be provided. CareFusion is providing compensating measures to help reduce the risk of exploitation for the affected versions of the system.

The affected products are automated supply cabinets used to dispense medical supplies that can document usage in real-time. The system includes automated devices that may be deployed using a variety of functional configurations. “The Pyxis SupplyStation systems have an architecture that typically includes a network of units, or workstations, located in various patient care areas throughout a facility and managed by the Pyxis SupplyCenter server, which links to the facility’s existing information systems,” the notice says.

It says that the software vulnerabilities could be exploited remotely by an attacker with low skill.

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