Devices

Exer Labs Illegally Marketing Exer Scan: FDA

A 10/17-1/24/2024 FDA inspection at Exer Labs in Denver, CO, determined that the firm is illegally marketing its Exer Scan. A just-released 2/10 Warning Letter says the firm does not have an approved PMA or IDE application for its device and also did not notify FDA of its intent to introduce the device into commercial distribution.

The inspection also found these Quality System Regulation violations:

failure to adequately establish procedures for design controls;
failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failure to adequately establish procedures for corrective and preventive actions;
failure to establish procedures to ensure all purchased or otherwise received products and services conform to specified requirements;
failure to establish procedures for management review;
failure to establish procedures for quality audits; and
failure to establish procedures for training and identifying training needs.

Exer Labs was told to cease activities that result in the misbranding or adulteration of the Exer Scan. FDA also told it to act promptly to correct the Quality System violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.

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