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FDA to evaluate ultrashort pulse lasers for medical applications

20 Jul 2007

A joint project between Raydiance and the US Food and Drug Administration will examine the safety and effectiveness of Raydiance's platform for laser-based medical treatments.

The two-year program will evaluate Raydiance's ultrashort pulse (USP) laser system, which combines fiber-optical components and micro-optics with advanced software control. The system produces a 1552 nm beam in pulse durations typically ranging from 800 fs to 1 ps, while the integrated software control enables pulses to be grouped into precise patterns or groups.

Such pulses can vaporize material without heat or residual damage, opening up several novel therapeutic and medical procedures. The study will initially focus on the use of USP lasers in four areas:
• ophthalmic applications, such as laser ablation of corneal tissues in refractive surgery and corneal repair,
• dental treatments, including non-surgical, non-drilling procedures,
• gene transfection, including the administration of gene therapy,
• light therapy treatments being developed for cancer, diabetes and cardiovascular conditions.

Under the two-year agreement the FDA will evaluate these procedures in detail, by using hardware, applications and systems support provided by Raydiance. The deal represents a major step towards future commercialization of the USP technology, and is also a significant development for the company.

"The FDA's research & development unit is one of their less familiar roles, going beyond their more familiar regulatory function," Scott Davison, president of Raydiance, commented to optics.org. "They're very selective about the areas that they choose to examine and only look at the most promising emerging technologies."

Most USP systems have previously been expensive, large and complex to operate, but the Raydiance platform has several advantages. The system is about the same size as a desktop PC and uses a standard power supply. It is claimed to take only five minutes to warm up, and requires no manual adjustment during use.

"In addition to miniaturizing and simplifying the Raydiance USP laser system, we deeply integrated computing technology into it," said Davison. "Pulse energies and repetition rates can be adjusted by the user; everything has been designed not just for broad versatility, but for ease of use. The intention is to make USP lasers usable by any doctor, scientist or engineer, not just by laser specialists."

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