Devices

Doc Group Wants FDA Probe of Musk’s Neuralink

The Physicians Committee for Responsible Medicine (PCRM) is asking FDA to open an inquiry into Elon Musk’s Neuralink brain implant company. PCRM says Neuralink should be investigated for possible violations of good laboratory practice (GLP) regulations. The company is already facing Department of Agriculture and Department of Justice probes.

PCRM says public records and recent whistleblower reports shared with the media suggest that Neuralink has failed to comply with GLP rules, which may disallow the use of the animal studies the company submitted in its FDA application for approval of its brain-machine interface.

The advocacy group says its ongoing public records lawsuit against the University of California, Davis, where Neuralink conducted experiments on rhesus macaques from 2017 to 2020, has so far found more than 700 pages of documents that may be central to an FDA investigation. “The documents detail that sloppy brain surgeries resulted in infections, seizures, paralysis, internal bleeding, and chronic hair loss, a sign of poor psychological health,” PCRM says.

The group says that implanted devices like Neuralink’s come with many problems, including the difficulty of repair and a high potential for severe medical complications in patients. It urges Neuralink to immediately halt its animal experiments and focus on improving non-invasive brain-machine interfaces.

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