Iridex laser delivery system cleared for noninvasive treatment of retinal diseases

Iridex (NASDAQ:IRIX; Mountain View, CA) has garnered FDA 510(k) and CE clearances for its TxCell Scanning Laser Delivery System. In laser photocoagulation procedures for treating retinal diseases noninvasively, the system allows laser delivery in a multi-spot scanning mode as well as the traditional single-spot mode.

The system, when combined with the company's IQ 532 or IQ 577 laser enabled with MicroPulse, provides multi-spot scanning, single-spot standard, and MicroPulse Laser Therapy modalities. MicroPulse is a noninvasive laser delivery therapy that electronically "chops" the laser emission into trains of microsecond pulses, says the company, enabling ocular treatment with less collateral effects than conventional laser treatments.

Initial shipments of the system have begun, with orders from a number of different countries.


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