An FDA advisory panel agreed on April 8 to recommend approval of Bausch + Lomb’s 1st-of-its-kind intraocular lens for patients who have had a cataract removed and would like to, without glasses, have improved distance vision and reduced residual refractive cylinder.
An FDA advisory panel agreed today to recommend that the federal watchdog agency approve Bausch + Lomb’s first-of-a-kind intraocular lens for patients who have had a cataract removed and would like to, without glasses, have improved distance vision and reduced residual refractive cylinder.
The panel voted 10-0 with 2 abstentions that Bausch + Lomb proved the Trulign Toric posterior chamber intraocular lens is safe; 10-1 with 1 abstention that the device is effective; and 10-1 with 1 abstention that its benefits outweight its risks.
An FDA advisory panel last week debated who should be allowed to implant NeuroPace’s anti-epilepsy device, where it should be implanted and which patients should be eligible for it on the way to recommending approval for the implant.
The federal watchdog agency’s Neurological Devices Advisory Panel, in a non-binding vote Feb. 22, recommended that the FDA approve NeuroPace’s RNS deep-brain stimulation therapy for certain categories of epilepsy, but had some reservations about the details
California neurostimulation devices maker NeuroPace crept 1 step closer to an FDA win for its epilepsy implant with near-unanimous approval from the FDA’s Neurological Devices Advisory Panel.
An FDA panel decision will require some cardiovascular pump makers to submit their already-approved medical devices for review under the FDA’s more stringent premarket review pathway.
The federal watchdog agency’s Circulatory Devices Advisory panel this week acknowledged that non-roller-type cardiopulmonary bypass blood pumps are life-supporting, but recommended against shifting them to a lower-risk category for temporary ventricular support. Panelists also suggested down-classification into Class II (special controls) for cardiopulmonary and circulatory bypass therapy.
The FDA’s Circulatory System Devices Panel voted on Dec. 5 to reduce the regulatory burden for intra-aortic balloon pump (IABP) devices to Class II (special controls) for certain indications, while keeping the more stringent Class III premarket approval requirement in place for a few uses.
An FDA advisory panel recommended that the federal watchdog agency grant a humanitarian device exemption to Second Sight Medical Products’ Argus II retinal prosthesis system, designed for patients who are profoundly blind due to a rare condition called retinitis pigmentosa.
Patients with retinitis pigmentosa have either bare light perception or none at all. There is currently no cure and no available treatment for the rare condition that’s diagnosed about 250 times each year.
FDA panelists last week agreed that, although there are no circumstances in which metal-on-metal hip implants are better than the alternatives, the medical devices should be left in patients who aren’t experiencing any problems.
Following a thumbs-up for its first-of-a-kind MarginProbe breast cancer detection device last week, Dune Medical Devices is promising to work closely with FDA to complete the approval process and plans an immediate U.S. launch should the watchdog agency give it a green light.
The FDA’s general & plastic surgery devices committee met June 21 in Gaithersburg, Md., to mull whether the device, which uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor, ought to be approved for the U.S. market.
High-risk medical devices intended to help obese patients lose weight should result in more weight loss than lower-risk methods, an FDA advisory panel said last week
"For a 1-and-done [a permanently implanted device], or a device equivalent to a gastric bypass, you should have higher expectations of the weight loss," said panelist Dr. Steven Schwaitzburg, of Harvard Medical School. "Whereas, if we have lower-risk devices and are able to establish other types of endpoints like bridge [to surgery], exercise, etc., then [a lower bar for excess weight loss would be acceptable]."