Devices

Soulaire Marketing Unapproved Device: FDA

FDA says it has learned that Soulaire Corp. in Santa Monica, CA, is marketing an external counter-pulsating device in the U.S. without marketing clearance or approval. A just-released 1/29 Warning Letter says the device is intended to treat chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization.

However, FDA says, the company is marketing the device for multiple intended uses outside of its original clearance, including the growth of new arteries, reduction or elimination of blood pressure medication, reduction of Covid-19 symptoms, and hair growth. “Your firm has not provided any evidence to FDA to substantiate the safety or efficacy of these uses,” the letter says, “and the agency is currently unaware of any data or literature that supports these claims.”

The letter says the device is adulterated because Soulaire does not have an approved PMA or IDE in place for it. It also is misbranded because Soulaire did not notify FDA of its intent to introduce the device into commercial distribution.

FDA requested that the company cease any activities that result in the misbranding or adulteration of the device, such as its commercial distribution for unapproved uses in addition to any other marketing claims/uses that have not received FDA clearance or approval. Soulaire was told to take prompt action to correct the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrective actions and a schedule for completing them.

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’

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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

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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