Devices

Musk Reports Implanting 1st Chip in Human Brain

Neuralink founder Elon Musk announced 1/29 that the company had implanted a chip in a human brain for the first time and that “initial results show promising neuron spike detection.” In a subsequent post on his social media platform X, Musk said Neuralink’s first product will be called Telepathy,” CNN (and other media) report. Musk and the company reportedly did not respond to requests for comment and additional information from media outlets.

FDA cleared Neuralink to start human clinical trials in 5/2023 and the company later started recruiting patients with quadriplegia caused by cervical spinal cord injury or amyotrophic lateral sclerosis. The trial is part of Neuralink’s PRIME (Precise Robotically Implanted Brain-Computer Interface) study looking at the safety of its implant and surgical robot, and testing the functionality of its device, according to a company trial recruitment post in 9/2023.

CNN reports the company said that trial participants would have a chip surgically placed by a robot in the part of the brain that controls the intention to move. The chip is to record and send brain signals to an app, with the initial goal being “to grant people the ability to control a computer cursor or keyboard using their thoughts alone.”

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

Read more

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