Devices

FDA Selects Dexcom as First Participant in Digital Health Pilot with CMS

FDA has selected Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, marking the launch of a joint FDA-CMS initiative designed to evaluate digital health technologies using real-world evidence while expanding access to innovative care for patients with chronic diseases.

FDA announced 7/22 that Dexcom's Glucose Health Program will be the inaugural device evaluated under the pilot. The program is intended to support care delivered through the CMA Innovation Center's Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, which began enrolling its first cohort in July.

According to FDA, the Dexcom program is intended to help patients and healthcare providers monitor metabolic and nutritional status through real-time data, artificial intelligence-driven insights, and personalized guidance. The agency said the program is designed to support screening for prediabetes and Type 2 diabetes and may contribute to improved glycemic control and lower HbA1c levels among people with prediabetes. The device will continue to undergo FDA review for its intended uses during the pilot.

The TEMPO pilot is intended to create a new regulatory framework for evaluating digital health devices in real-world clinical settings. Participating manufacturers will collect, monitor, analyze, and report real-world data on device performance and patient outcomes while their products are used in care delivered through the ACCESS payment model.

FDA said it plans to enroll about 10 manufacturers in each of four clinical use areas covered by the ACCESS model, with participants selected from U.S.-based companies. Selection criteria include patient safety, the potential for clinical benefit, manufacturers' plans for collecting and reporting real-world data, and alignment with the health outcomes measured under the ACCESS model.

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