AcuFocus Inc.
Ex-Advanced Medical Optics CEO Mazzo indicted in insider trading case
Press Release: AcuFocus small-aperture IOL receives CE Mark for Europe
Irvine, CA – AcuFocus, Inc. (www.acufocus.com), the global leader in small-aperture technology, today announced that its extended depth of focus intraocular lens (IOL), the IC-8™ small aperture IOL, has achieved CE Mark (Conformité Européenne) approval in Europe. The lens is designed to provide exceptional visual quality across a broad range of vision for presbyopic patients with cataracts.
Vision: AcuFocus lands E.U. approval for next-gen eye implant
California-based device maker AcuFocus is taking its next-generation intraocular lens to Europe after winning regulatory approval to treat cataract patients with near vision loss, or presbyopia.
AcuFocus adds $21M for Kamra presbyopia inlay
AcuFocus said today that it raised another $21 million in an oversubscribed round as it awaits a decision from the FDA on its Kamra device, a corneal inlay designed to treat near vision loss, or presbyopia.
UPDATE: AcuFocus’s Kamra Inlay wins a narrow nod from FDA panel
FDA experts issue mixed vote on Kamra vision-improving implant
A panel of FDA experts today was divided on whether the federal watchdog agency should approve the AcuFocus Kamra Inlay, a 1st-of-a-kind permanent corneal implant for the improvement of near and intermediate vision in patients with presbyopia, a form of age-related far-sightedness.
Medtronic-backed AcuFocus wins FDA panel date for Kamra inlay
The FDA said it plans to hold an advisory panel hearing to evaluate the Kamra Inlay device made by AcuFocus to treat presbyopia, or near vision loss.
The FDA’s Ophthalmic Devices Panel will convene June 6 to consider AcuFocus’ bid for pre-market approval for the Kamra device, a ring-shaped inlay that’s implanted under the surface of the cornea, the federal watchdog agency said today.
Insulet appoints 1st medical director | Personnel Moves
Insulet (NSDQ:PODD) said it named Dr. Howard Zisser, the former clinical director of the Sansum Diabetes Research Institute, as its 1st medical director.
Considered a leader in diabetes research, Zisser will be involved with a variety of clinical research projects and serve as a medical liaison between Insulet and government leaders, the FDA, and healthcare organizations, Bedford, Mass.-based Insulet said.
MassDevice.com Q&A: James Mazzo on his move to Versant Ventures
James Mazzo has put 35 years into the optics and ophthalmology business, so it was no surprise that he got involved with AcuFocus and its device for treating presbyopia. Mazzo, who stepped down from leading Abbott Medical Optics earlier this year, added another title to his resume that’s more of a departure: He’s the 1st "operating partner" at Versant Ventures.
FDA clears Ethicon’s 1st surgical set docs can assemble inside the body | Regulatory Roundup
Johnson & Johnson (NYSE:JNJ) Ethicon Endo-Surgery won FDA clearance for the 1st surgical instruments that can be assembled and disassembled inside the body during surgery.