FDA OFFICIAL WITH OVERSIGHT OF MUSK’S NEURALINK DEVICES FIRED

(Bloomberg) -- An official who oversees a team at the Food and Drug Administration that reviews Neuralink Corp. devices was fired, according to an email the agency sent to staff Tuesday morning viewed by Bloomberg.

Ross Segan, who was formerly the director of the Office of Product Evaluation and Quality at the FDA’s medical device center, was one of thousands of employees fired across the US Department of Health and Human Services in recent days. 

The firings, some of which hit the device division, followed an executive order last week directing agencies to reduce their workforces in line with the goals of the Elon Musk-led Department of Government Efficiency. Musk has founded several companies including the medical device firm Neuralink. 

Segan was part of the chain of command that oversees the review of Neuralink devices.

Musk’s Neuralink is developing an implanted brain-computer device that aims to allow people with paralysis to operate electronic devices using only their thoughts. Neuralink has registered two US trials with the FDA for its implants. One trial allows patients to control devices such as smartphones, and another allows patients to control devices including robotic arms.

Segan occupied a top role at the FDA’s Center for Devices and Radiological Health. He oversaw a division of reviewers that examined devices related to neurosurgery, which includes Neuralink’s devices. Segan had worked at the agency since September 2024, according to his LinkedIn profile. People who have worked at a federal agency for less than a year generally have fewer civil service protections than employees with longer tenures. 

While its early trials, known as feasibility studies, are underway, Neuralink still must conduct regular check-ins with the FDA, particularly if something doesn’t go as expected, said former FDA official Cristin Welle. Last year, Neuralink said electrode-studded threads had moved out of position in its first patient, Noland Arbaugh; after software tweaks, the company was able to improve the performance of the device. That is the type of event that would likely prompt discussions with the FDA, Welle said.

The FDA has the power to halt a trial at any time.

Neuralink would also need the FDA to approve the next major type of trial, called a pivotal trial, when the device goes into more patients. Those studies typically start after a company has six to 12 months worth of data on each patient in the feasibility study and once the FDA has reviewed those early results. The company has approval from the FDA to implant its devices in humans as part of studies. Musk said in January that the company had implanted its third device, and has plans for about 20 to 30 more this year. 

Welle said the situation is not ideal. “If you’re cutting staff in the division that is regulating your products specifically, it does pose the appearance of a conflict,” she said. 

The person in Segan’s former position has influence over the approval process for medical devices, any conditions companies have to meet after their devices are approved, and how reviewers manage their workloads. Many companies with similar devices to Neuralink are at various phases of their own FDA clinical trial processes, including Synchron, Paradromics, Precision Neuroscience and Science.

Segan, who goes by Rusty, had sent emails to staff to encourage them to continue in their mission of public service, according to a reviewer in his division who was fired on Saturday. 

The FDA didn’t respond to a request for comment Monday night. Neuralink didn’t immediately respond to a request for comment on Tuesday.

Reviewers who worked on Neuralink were also fired, Reuters reported Monday. Segan’s departure was first reported by STAT. 

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2025-02-19T00:13:16Z