Iridex Receives FDA and CE Mark Approval for Laser Delivery System

Iridex, a medical device manufacturer based in Mountain View, California, received CE Mark clearance in the European Union and approval from the United States Food and Drug Administration for its TxCell scanning laser delivery system. The TxCell system provides non-invasive treatment for severe retinal diseases.

According to a press release by the company, the TxCell scanning laser delivery system is designed to assist physicians during certain ophthalmological procedures. By facilitating easier delivery of a laser in multi-spot scanning mode, the TxCell system can improve physician ease-of-use and patient safety.

Will Moore is CEO and president at Iridex. In prepared remarks, he said, "Broadening market acceptance for medical technologies typically involves effective clinical results, ease of use for the physicians and more efficient use of time.” He continued, "TxCell can deliver all 3 benefits and is an important step in accelerating the adoption of our proprietary MicroPulse technology as it applies to several clinical procedures."

The company’s MicroPulse technology gives tissue time to cool. By spacing laser pulses out over a proprietary time period, the system is able to reduce the risk of tissue damage. At the same time, the system is able to provide the comfort and convenience of traditional continuous-wave laser systems. The company stated that it is currently shipping its TxCell and MicroPulse systems to several different countries.

References

www.iridex.com/News/articleType/ArticleView/articleId/9.aspx