The FDA last month shot down a petition filed by the former staffer who approved Lasik eye surgery, saying the evidence presented in the petition isn’t strong enough to justify revoking pre-market approval and initiating a recall.
Optical/Ophthalmic
‘Bionic eye’ maker Second Sight files for $32M IPO
Second Sight Medical hopes to raise $32 million through an initial public offering in support of its wearable visual prosthetics.
The company plans to offer shares at $9 apiece, saying it’ll used the proceeds from its IPO to boost sales & marketing, seek regulatory approvals in new regions and work on the next generation of its technology for helping restore vision to the blind.
Retina Implant wins German reimbursement for vision-correcting microchip
Retina Implant AG announced this week that it won reimbursement from Germany’s government health system to cover the company’s flagship Alpha IMS microchip, an implantable device for helping to correct vision in patients with late-stage retinitis pigmentosa (RP).
The reimbursement win is Retina Implant’s 1st in the world, coming from the company’s home country.
LensAR raises $8M for laser eye surgery
Opthalmology devices maker LensAR secured $8 million in equity funding, according to an SEC filing dated July 31, 2014.
Ocular Therapeutix prices IPO below range
Ocular Therapeutix said this morning that it plans to put up 5 million shares at $13 apiece on the NASDAQ exchange today.
That’s a dollar below the projected price range the Bedford, Mass.-based company issued earlier this month.
Novartis partners with Google on smart contact lenses
Warning letter prompts lawsuit against Staar Surgical
Ocular Therapeutix sets terms for IPO
Ocular Therapeutix is looking to raise as much as $80 million in a forthcoming initial public offering, the company said today.
Bedford, Mass.-based Ocular Therapeutix said it plans to offer 5 million shares at $14 to $16 apiece, making the IPO worth $70 million to $80 million.
Calhoun Vision aims to disrupt ophthalmology with its light-adjustable lens
For years the Holy Grail of ophthalmology has been to give patients the ability to see clearly both and near and far distances. Verne Sharma, CEO of Calhoun Vision, thnks his company’s light-adjustable lens has reached that goal.
FDA warns Staar Surgical for missing documentation
FDA regulators put the heat on Staar Surgical (NSDQ:STAA), revealing a warning letter citing the California company on 15 design and quality control issues.