Devices

Prometheus, Owner Paying $550,000 for False Claims

The Justice Department says it has reached a settlement agreement with New Hampshire medical device manufacturer Prometheus and its owner, Richard Poore, to pay the government $550,000 to resolve False Claims Act allegations. A suit against the company and Poore alleges that they caused healthcare providers to bill Medicare for services in which the providers improperly re-used single-use catheters on multiple patients.

A department statement says Prometheus manufactures and sells systems for use in pelvic muscle rehabilitation. Specifically, it says, it has manufactured and marketed the Pathway CTS 2000 pelvic floor training system and the Morpheus system. Both systems required the use of a rectal pressure probe that is inserted into a patient’s rectum during therapy, the statement says.

While FDA cleared the rectal pressure sensor as a single-use device, the department says, the defendants for years encouraged and instructed healthcare providers to reuse the sensor on multiple patients, using a glove or condom to cover the probes, as a way to reduce overhead costs associated with the systems.

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