Ultrasound-guided drug delivery gets FDA nod

The FDA has cleared an injection system that combines technologies to deliver meds safely and precisely. With its built-in ultrasound tech, the computer-controlled system allows clinicians to see in real-time the position of a needle during injections and the release of drugs, according to the system's venture-backed developer, Carticept Medical.

The system aims to improve injections of treatments for arthritis pain, which affects tens of millions of Americans. In standard cases, a clinician uses her skill to make injections at the correct location. Alpharetta, GA-based Carticept's system, called Navigator DS, appears to take some of the room for human error out of the business of making injections. It also automatically prepares specific doses of medicine, saving clinicians from that task as well. Once an injection is made, the unit creates a record of the injection that can be stored in an electronic health record, according to the 6-year-old company.

Carticept--which has investors that include Domain Associates, New Enterprise Associates (NEA) and SonoSite--garnered 510(k) clearance from the FDA to market the system in the U.S. Still, that clearance doesn't guarantee sales success, and the company faces the challenge of marketing the system to physicians and other buyers who might be willing to pay for the benefits that the product offers. To aid their cause, the company cited a study in The American Journal of Sports Medicine which found that the use of imaging when making injections into the shoulder and knee improved the accuracy of the injections.

"Minimally invasive and cost-effective injections can delay and in some cases eliminate the need for surgical intervention," Dr. John Reach, an assistant professor in the department of orthopedic surgery at Yale University's School of Medicine, said in the company's release. "Recent studies have demonstrated greater accuracy with improved function and decreased pain in patients receiving ultrasound-guided injections."

- here's the release

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