Devices

Senator Urges Justice Probe of Respironics

Sen. Richard Blumenthal (D-CT) is calling on the Justice Department to take action against Philips Respironics after a recent investigation by ProPublica and the Pittsburgh Post-Gazette revealed the company kept secret more than 3,700 complaints about its faulty CPAP breathing devices over the course of 11 years before launching a massive recall in 2021, according to a new report by ProPublica.

“Philips brazenly turned a blind eye to its dangerous defective machines all in the name of profit,” Blumenthal told the news service. Previously, Philips acknowledged that an industrial foam placed inside the devices to reduce noise could break down in heat and humidity and release material into the air paths of the machines, the investigation found.

“Philips knew about the serious risks of its breathing machines for years, but inexcusably, withheld critical information,” said Blumenthal. “The DoJ must take immediate, aggressive action against Philips for its years-long wrongdoing.”

Safety tests on the foam by Philips following the recall were called into question by CDRH 10/5 (see earlier story), saying they were inadequate and did not “fully evaluate the risks posed to users… Although Philips concluded that the exposure to foam particles and volatile organic compounds from these devices is ‘unlikely to result in an appreciable harm to health in patients,’” CDRH said. “FDA believes additional testing is necessary. Philips has agreed to conduct the additional testing. Based on the currently available information, FDA maintains its recommendations regarding the potential health risks associated with the PE-PUR foam breakdown in these recalled devices.”

The Justice Department, which has been investigating the company’s testing practices and safety claims, can impose various penalties against medical device companies in violation of federal safety laws, including civil sanctions and criminal charges, Propublica noted.

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