Devices

AseptiKits Marketing Adulterated, Misbranded Devices: FDA

A 11/9-12/3/2025 FDA inspection at AseptiKits in North Salt Lake, UT, found that the company manufactures and markets several PALA Your Tears models. A just-released 6/4 Warning Letter says the firm’s PALA Your Tears models are adulterated because the firm does not have an approved PMA or IDE in effect for them. The products are also adulterated, FDA says, because AseptiKits did not notify the agency of its intent to introduce the products into commercial distribution.

The letter says the company maintained that its products are exempt from premarket notification, and the letter provides FDA’s rebuttal. “Our office requests that you immediately cease any activities that result in the misbranding or adulteration of your devices, such as the commercial distribution for the uses discussed above,” the letter says.

AseptiKits was told to act promptly to address the violations and to respond with a list of specific steps it has taken to correct 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