FDA Policy/General

TransMedics Gets Heart Trial Conditional Approval

FDA has granted TransMedics Group conditional approval to begin its next-generation Organ Care System (OCS) ENHANCE heart trial. The trial is designed in two parts, according to the company, and will assess the capabilities of TransMedics’ proprietary heart technology. TransMedics says it's OCS platform is designed to maintain organs in a functioning, perfused state outside the body, potentially extending preservation times and improving transplant outcomes.

Part A of the study will focus on the feasibility of prolonged heart perfusion using the OCS Heart platform, according to the company. Part B will compare outcomes between traditional static cold storage and OCS heart perfusion for donor hearts from brain-dead donors — a category not currently included in the current device’s approved use.

Together, both trial phases are expected to enroll over 650 patients, making it the largest heart preservation trial for transplant ever conducted globally, the company says. “These trials could serve as major catalysts for broader clinical adoption of our technology in 2026 and beyond,” it adds..

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