EBS Technologies said it won CE Mark approval in the European Union – plus a cool $3.9 million in Series B financing – for its Next Wave deep-brain stimulation device, touting positive clinical data on the way.
Optical/Ophthalmic
FDA approves Bausch + Lomb’s eye implant
California medical device maker Bausch + Lomb announced today that it won FDA approval for its 1st-of-its-kind Trulign Toric intraocular lens.
The regulatory approval grants B+L permission to market the lens in the U.S. for treatment of astigmatism as well as improving vision across a natural range of focus without the use of glasses.
FDA clears Abbott’s Tecnis Toric intraocular lens
Healthcare giant Abbott (NYSE:ABT) is planning an immediate commercial launch, having won FDA clearance for its Tecnis Toric intraocular lens.
Abbott landed indication to market the Tecnis Toric lens to cataract patients with pre-existing corneal astigmatism, a condition in which the cornea of the lens in uneven, according to a company statement.
Bausch + Lomb laser device wins new approvals in Europe
Bausch + Lomb won new CE Mark approvals for its Victus laser platform, allowing the device maker to market the system for additional uses during cataract surgery.
In additional to corneal incision, European regulators approved 2 additional indications for Victus, green-lighting the system for use during full corneal transplant, or penetrating keratoplasty, and for incisions performed during device implants into the eye.
Alcon Labs issues hazard alert on certain intraocular lenses
Alcon Laboratories in conjunction with Australian healthcare regulators issued a warning on certain intraocular lenses after receiving reports of higher-than-expected rates of accelerated endothelial cell loss.
FDA OKs a new iPhone prescription vision test | MassDevice.com On Call
MASSDEVICE ON CALL — U.S. healthcare regulators granted 510(k) clearance to Vital Art & Science’s myVisionTrack prescription iPhone vision test.
The test, which uses a test called shape discrimination hyperacuity to evaluate vision, is designed to monitor and record vision in patients with serious degenerative eye conditions.
FDA panel recommends approval, questions benefits of Bausch + Lomb eye implant
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.
BREAKING: FDA panel recommends approval for Bausch + Lomb’s Trulign Toric eye implant
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.
Recall: Hoya Surgical Optics pulls intraocular lenses amid adverse event reports
Singapore-based Hoya Surgical Optics recalled 5 models of its intraocular lenses after receiving reports of higher-than expected rates of inflammation from doctors in several countries.
Healthcare regulators in the U.K. and in Australia have both reported the recall, asking doctors to stop using the implants immediately.
Medtech M&A Madness | Wall Street Beat
LensAR lands another FDA clearance for cataract laser surgery
The laser cataract surgery market has another player, now that the FDA’s cleared its laser surgery device for another type of incision used during cataract surgery procedures.
LensAR said it won 510(k) clearance from the FDA for its laser cataract surgery device for arcuate incisions to the edge of the cornea.