Devices

FDA, CMS Launching Tempo Pilot

FDA and the Center for Medicare and Medicaid Services’ Center for Medicare and Medicaid Innovation (CMMI) are launching the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices pilot. An FDA Digital Health Center of Excellence announcement says FDA will work with CMMI’s Advancing Chronic Care with Effective Scalable Solutions (ACCESS) model to promote access to certain digital health devices while safeguarding patient safety. The statement says FDA will gather statements of interest for participating in the TEMPO pilot beginning in 2026.

Through the ACCESS model, FDA says, the Center for Medicare and Medicaid Services will test a new payment option that emphasizes patient outcomes. “If a manufacturer seeks to offer its device for an intended use to improve patient outcomes,” the notice says, “such that it may be used to provide care covered by the CMMI ACCESS model, FDA generally expects the device to be FDA authorized for that use. However, manufacturers of certain digital health devices that are not already authorized by FDA for such use may request to participate in the TEMPO pilot and request that FDA exercise enforcement discretion and not enforce certain applicable requirements, such as premarket authorization requirements, when their device is offered to or by CMMI ACCESS participants for an intended use to improve patient outcomes, to be used in providing care expected to be covered by the CMMI ACCESS model.”

FDA says it plans to select up to about 10 manufacturers in each of four specific clinical use areas to participate in the pilot.

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