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Working together to deliver innovative medical care

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Karen A. Newman

The FDA says it has a way to cut nearly in half the time it takes the agency to review most premarket approval applications for high-risk or novel medical devices.

In a world in which new consumer products and new versions of popular products from cell phones to sports drinks hit the market at a breathtaking pace, there is always someone, somewhere, waiting for the next breakthrough in medicine or medical devices that could save or greatly improve his or her life. Cutting as much as 150 days off the preliminary approval process for innovative medical devices seems like a step in the right direction.

The proposed Innovation Pathway program, announced Feb. 8, seeks to encourage cutting-edge technologies as well as to establish a third-party certification program for device test centers to promote rapid improvements to new technologies, to create a core curriculum to train next-generation device innovators, and to use more device experience and data from outside the US. A pilot project for the program is at hand: A brain-controlled prosthetic arm is the first device submitted under the Innovation Pathway guidelines.

At an innovation workshop at Photonics West, Dr. Jonathan Sackner-Bernstein told a group that the FDA is geared toward facilitating innovation. Sackner-Bernstein, who is with the FDA’s Center for Devices and Radiologic Health, urged attendees to think carefully about how they put together a proposal for a new device and to consider risk in a broader context, thinking about both the safety and the effect of the device.

“FDA is there to work with you to speed to market those products that can really make a difference for people with great, unmet health care needs,” he said.

A public meeting on the Innovation Pathway program was set for March 15. The program is not yet funded.

There are no features in this issue addressing innovative medical devices, but there are a number of good articles shedding light on various other aspects of biophotonics. One article in particular is our cover story on small-animal imaging, found on page 18. When imaging animals, investigators often want to see how an organ is working inside the body. In vivo imaging gives researchers a good look at what is going on.

Enjoy the issue, and when you’re ready to put it down and look at other images, may I suggest you visit and view the latest edition of Light Matters, Photonics Media’s weekly headline video newscast. Web editor Melinda Rose hosts the weekly production, which you can find on the home page.

Mar 2011
BiophotonicsCenter for Devices and Radiologic HealthEditorialFDAimagingindustrialInnovation PathwayJonathan Sackner-Bernsteinmedical devices

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