Devices

AdvaMed Urges FDA/CMS Alignment on Breakthrough Devices

AdvaMed and other device stakeholders are urging the Centers for Medicare & Medicaid Services (CMS) to overhaul how it covers new device technologies, warning that patients are waiting years too long for access to innovations approved and cleared by FDA. In a recent letter to CMS administrator Mehmet Oz, the groups called for the creation of a “timely, streamlined pathway” to ensure that Medicare beneficiaries benefit from breakthrough devices and diagnostics as soon as they reach the market. They said Medicare’s current processes lag far behind the pace of medical innovation, pointing to a recent study showing that new devices take nearly six years, on average, to win reimbursement coverage after FDA authorization.

“Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life,” the letter argues. AdvaMed highlights data showing medical technology has already driven dramatic improvements in U.S. health outcomes, including a 43% drop in breast cancer mortality, a 49% reduction in deaths from heart disease and stroke, and shorter hospital stays. New diagnostics are also advancing earlier detection of Alzheimer’s and Parkinson’s disease.

The trade group criticizes existing CMS initiatives such as the Transitional Coverage of Emerging Technologies program, calling it “voluntary” and “limited” in scope. Instead, it urges CMS to adopt an approach modeled on the earlier Medicare Coverage of Innovative Technology framework, which would grant automatic, time-limited coverage to FDA-designated breakthrough devices while CMS collects evidence for longer-term reimbursement decisions. Legislation pending in Congress, including the Ensuring Patient Access to Critical Breakthrough Products Act (S. 1717), mirrors that concept. AdvaMed says pairing FDA and CMS processes more closely would cut regulatory red tape and “demonstrate CMS’s commitment to patient-centered care.”

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