Devices

Jet Medical, Other Companies, Pay $700,000 in Device Cases

The Department of Justice says Pennsylvania-based Jet Medical will pay $200,000 to resolve criminal allegations relating to a medical device migraine headache treatment, and Jet and two related companies will pay another $545,000 in a civil settlement involving the same device. A department statement says the federal government alleges that between 4/2014 and 4/2019 Jet introduced into interstate commerce devices that were misbranded under the Federal Food, Drug, and Cosmetic Act because the company did not obtain FDA clearance or approval before distributing the devices.

Jet’s Allevic SPG Nerve Block Catheter (Allevio) was intended to treat migraine headaches by administering nerve blocks to the sphenopalatine ganglion, a collection of nerves located deep in the midface of the skull, the department says.

A criminal information filed in an Illinois federal court alleges that Jet never sought clearance or approval from FDA to distribute the Allevio for the intended use and did not conduct an investigational study on Allevio’s safety and effectiveness when used as intended.

The resolution includes a deferred prosecution agreement and criminal penalties totaling $200,000, the statement says. As part of the agreement, Jet admitted that it distributed misbranded devices and agreed to implement enhanced compliance measures. It also includes a civil settlement under a False Claims Act whistleblower suit totaling $545,133.

Medical Components, Inc., and Martech Medical Products, Inc., are part of the civil settlement with Jet.

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