Devices

Lab Group Seeks Congress’ Help on LDT Rule

The Association for Diagnostics and Laboratory Medicine (ADLM) is voicing significant concerns regarding the recent FDA final rule on laboratory developed tests (LDTs), and it is urging Congress to intervene while judicial reviews determine the agency’s authority to regulate LDTs. ADLM also urges Capitol Hill to explore separate solutions to streamline the FDA review process and update CMS standards related to LDTs.

In a 9/5 letter to Senate and House lawmakers, the group cautioned that the new rule could potentially impact the ability of clinical laboratories to deliver timely and quality patient care, according to data collected from multiple surveys. For example, ADLM’s June survey found that laboratories faced significant challenges. Over half of the testing facilities reported they would discontinue some LDTs due to difficulties in meeting the new requirements. Additionally, about 60% of hospitals indicated they could not comply with the rule’s unmet need exceptions, with nearly 70% of those facilities planning to discontinue LDTs as a result.

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