Devices

Support Device Identifiers in Claims Data: Pew

The Pew Charitable Trusts says HHS should support incorporation of medical device identifiers, particularly implants such as cardiac stents and artificial joints, to claims data as part of efforts to promote healthcare system competition and efficiency. The group’s 1/25 letter says that adding unique device identifiers (UDIs) to patients’ health records cannot provide the same benefit as claims. “Claims, unlike other data sources, contain data for nearly every encounter with the healthcare system for a specific individual,” Pew says…. “Adding UDIs to claims would allow researchers to use claims to evaluate devices in the same way they already evaluate drugs and procedures, thus equipping patients and clinicians with more data to make informed medical decisions.”

The advocacy organization also notes that incorporating UDIs in claims can generate healthcare system savings, and says that such a policy is supported by the Medicare Payment Advisory Commission and other healthcare system groups, as well as members of Congress from both parties.

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