Devices

Unetixs Vascular Selling Illegal Devices: FDA

A 9/19-12/4/2025 FDA inspection at the Unetixs Vascular facility in Warwick, RI, determined that the firm is illegally selling adulterated and misbranded vascular diagnostic ultrasound systems, including the ROODRA and 2CP devices. A 4/15 Warning Letter says the devices are adulterated because the firm does not have an approved PMA or IDE for them. The devices are misbranded, FDA says, because Unetixs did not notify the agency of its intent to introduce the devices with modifications into commercial distribution.

The letter says that while the two devices have a prior 510(k) clearance, the modified devices that are being distributed include both design and labeling modifications. “Our review found that the change was implemented to significantly mitigate a known risk in response to an adverse event,” it says. “Specifically, the device design, construction materials, and labeling changes, to physically prevent device misconnections, were implemented to address a complaint of a death caused by an embolism.”

FDA reminds Unetixs of a 2/4/2020 Warning Letter that cited significant Quality System violations related to the firm’s vascular diagnostic ultrasound systems. “We understand that while you have made progress in implementing corrective actions,” the agency says, “deficiencies remain as documented during the recent inspection.”

FDA says Unetixs should correct the violations promptly and should respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation for each corrective action 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’

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