FDA advisory panels Archives - Medical Design Sourcing

FDA advisory votes against BrainsGate’s neurostim device for treating stroke

At the end of last week, an FDA advisory panel voted down BrainsGate’s neurostimulation device for treating stroke.

BrainsGate designed its technology as a five-minute procedure in which a neurostimulator implant is injected into an existing canal to stimulate a nerve center and augment collateral blood flow, improving stroke patients’ outcomes within a 24-hour window.

The platform has CE mark approval and BrainsGate initially applied for FDA premarket approval in February 2020.

Meeting on Friday, the panel voted 7-3 (with three abstentions) against the device, determining that the benefits of BrainsGate’s treatment did not outweigh the risk for patients as reasonable assurance of effectiveness was not provided, although assurance of safety was evident, according to an FDA executive summary.

A major hangup for the panel was the fact that the device changed during the course of BrainsGate’s clinical trial of more than 1,000 subjec…

FDA advisory panel gives positive ruling on TransMedics OCS Liver System

TransMedics (NSDQ:TMDX) announced last night that an FDA advisory panel issued a favorable vote in support of approval for its OCS Liver System.

Yesterday, the Nasdaq market halted trading of TransMedics’ common stock as it awaited the outcome of a meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review the premarket approval application for its Organ Care System (OCS) Liver System, a portable organ perfusion and monitoring medical device.

Shares of TMDX were up nearly 13% at $35.79 per share in pre-market trading as the news of the advisory committe’s ruling makes its way around.

Andover, Mass.-based TransMedics said in a news release that the panel voted 14-to-0 in favor of the fact that there is reasonable assurance that the OCS Liver System is effective, with a 14-to-0 vote favoring the fact that there is reasonable assurance of the OCS Liver System’s safety.

Th…

Nasdaq halts trading of TransMedics stock with FDA set to review OCS Liver System

TransMedics (NSDQ:TMDX) announced today that the Nasdaq market halted trading of the company’s common stock.

Andover, Mass.-based TransMedics, which develops organ transplant transportation platforms, saw its common stock close down -5.3% at $31.69 yesterday.

The company awaits the outcome of today’s meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review the premarket approval application for its Organ Care System (OCS) Liver System, a portable organ perfusion and monitoring medical device.

Intended to preserve a donated liver in a near-physiologic, normothermic and functioning state, the OCS Liver System also optimizes liver function for eventual transplantation, according to a news release.

The FDA will meet at 9 a.m. ET today to review the PMA application. This story may be updated.

TransMedics says FDA advisory committee will review its OCS Liver System in July

TransMedics (NSDQ:TMDX) announced that the FDA confirmed that it will review its premarket approval application next month.

Andover, Mass.-based TransMedics said the FDA scheduled a public advisory committee meeting to review the PMA application for the OCS Liver System, an organ transplant transportation platform, for July 14, 2021.

In the committee meeting, the FDA’s Gastroenterology & Urology Devices Panel of the Medical Devices Advisory Committee will discuss the platform, make recommendations and vote on a recommendation for approval of the OCS Liver System, according to a news release.

“We are looking forward to presenting the OCS Liver PROTECT data to the advisory committee panel in support of our PMA for the OCS Liver System,” TransMedics president & CEO Dr. Waleed Hassanein said in the release. “This is another important milestone to bring TransMedics closer to having all of our three organ platforms approved by F…