Devices

Dolor Tech Settles Over Migraine Device

Utah-based medical device company Dolor Technologies has entered into a settlement agreement with the U.S. government to resolve Dolor’s civil liability relating to a device it sold for treating migraines. “This resolution requires Dolor to make monetary payments to the U.S. based upon its ability to pay,” a Justice Department release says.

The government says that between 2013 and 2017, Dolor violated the False Claims Act by causing medical providers to submit false claims to Medicare for procedures using a device called the SphenoCath, which 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. However, the government contends that SphenoCath was not approved, cleared or authorized by FDA for such use.

“Device companies that evade the FDA approval process and improperly promote their products undermine the health of patients and the financial integrity of federal health care programs,” the release says.

In a related matter, former Dolor CEO Mark Wright pleaded guilty in federal court on 10/11 to misdemeanor charges of causing the introduction of misbranded and adulterated medical devices into interstate commerce (see earlier story). As part of Wright’s guilty plea, the government said, he admitted that while FDA recommended in 4/2014 that Dolor proceed with investigational studies about the device’s safety and effectiveness, the company never conducted any studies, but instead continued to market the device as a migraine treatment.

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