Carnegie Mellon Spinoff, Blue Belt Technologies Inc., Receives FDA Clearances-Center for Innovation and Entrepreneurship - Carnegie Mellon University

Tuesday, June 25, 2013

Carnegie Mellon Spinoff, Blue Belt Technologies Inc., Receives FDA Clearances

PITTSBURGH—Blue Belt Technologies Inc., a medical technology company developing the next generation of "smart" surgical instruments with precision robotics, has become the first spinoff from Carnegie Mellon University's Center for Technology Transfer and Enterprise Creation (CTTEC) to receive FDA clearances.

"The Center for Technology Transfer and Enterprise Creation has been essential to our success, said Eric Timko, CEO of Blue Belt. "Its staff helped us to spin out of CMU's Medical Robotics Technology Center in 2003 and provided us with valuable guidance as HealthpointCapital LLC acquired the company in 2011."

In December 2012, the company received its first 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its NavioPFS™ orthopedic surgical system. The NavioPFS provides precise robotic control to surgeons performing minimally invasive surgeries via an intelligent, handheld, computer-assisted bone-cutting tool.

Within six weeks of receiving the clearance to market the NavioPFS, Blue Belt made its first sale to Community Regional Medical Center in Fresno, Calif. Dr. D. Kevin Lester performed the nation's first partial knee replacement surgery with the system in February.

The company, with offices in Pittsburgh and Plymouth, Minn., received its second FDA clearance June 4 for its STRIDE™ Unicondylar Knee implant system, which provides advanced implant features optimized for use with the NavioPFS.

"Our goal with Blue Belt — and each of the teams we work with — is to facilitate and accelerate the movement of research and technology out of the university and into the marketplace," said Tara Branstad, CTTEC associate director...Read more»

By: Abby Simmons