Haag-Streit Surgical receives FDA 510(k) clearance for intraoperative-OCT camera

HAAG-STREIT SURGICAL announced its intraoperative-OCT camera has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for marketing on the largest medical device market in the world. The intraoperative Optical Coherence Tomography (iOCT^®) is already being successfully used for cataract operations, lamellar keratoplasties, membrane peelings, and for the treatment of retinal disorders. The ASCRS congress, to be held in San Diego (18 – 21 April 2015), marks the launch of the iOCT^® system in the US.

During the course of the surgical procedure, the iOCT^® system allows non-invasive, contact-free imaging so that the structures and layers within the tissue are visible to the surgeons. The iOCT^® camera is distinct owing to its premium quality iOCT^® scans that are displayed in real time in shades of grey. These scans, as also the iOCT^® videos, images, and the iOCT^® 3D volume scans can be stored for documentation and subsequent follow-ups.

“We are very pleased with the success of the iOCT^® camera in Europe and eagerly await the launch of the system on the US markets”, says Dr Eva Lankenau from OPMedT, developer and manufacturer. “Since the market launch with numerous surgeons four years ago, the iOCT^® camera has proved to be in great demand. In particular, the physicians appreciate the high resolution of the iOCT^® scans and the synchronous picture-in-picture superimposition”.

Since very recently, these iOCT^® images can be displayed synchronously with the microscope overview in both oculars, i.e. the surgeon can avail of a picture-in-picture superimposition (C.INJECT 900). This synchronicity helps the physician to steer the treatment field with ease, which smoothens the operative workflow enormously. In addition, the iOCT^® is attached to the zoom and to the focusing of the surgical microscope, which allows an identical field of view both through the microscope as well as in the iOCT^®.

Joachim Gerike, CEO of HAAG-STREIT SURGICAL, adds:

This approval confirms the premium quality and the long-term commitment offered by HAAG-STREIT SURGICAL in the domain of ophthalmic and microsurgical medical equipment.