Devices

Federal Court Hits Clinic Owner on Device Adulteration

The Western Michigan District Court has sentenced Roger D. Beyer to 57 months in federal prison for his involvement in a conspiracy to commit healthcare fraud and 12 months concurrently for the adulteration of medical devices. Beyer previously owned and operated Urological Solutions of Michigan, a mobile medical practice providing urological services to patients in their homes and assisted living facilities.

During the fraud investigation, investigators discovered that the firm reused a single-user rectal pressure sensor on multiple patients, covering the device with the finger of a surgical glove, the government contends. Staff also reused a single-use anorectal manometry catheter on multiple patients as part of an initial diagnostic study in patients with potential fecal incontinence, covering the device with a condom. “The reuse of these medical devices was in contravention with the devices’ instructions for use and inconsistent with the device clearances by FDA,” it says.

The court also found that Beyer engaged about $883,000 in false claims paid by Medicare.

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