connectBlue’s Serial Port Adapter, supplied by Code Blue Communications, Inc., has been integrated as a key wireless component of the first Bluetooth medical application to be granted market approval by the US Food and Drug Administration (FDA).
An OEM version of the Serial Port Adapter enables wireless communication between operating room equipment and a central control system developed by Stryker Endoscopy — a leading supplier of medical equipment for operating room applications worldwide.
“This decision marks a major milestone for the Bluetooth industry and clearly reinforces our long held conviction that the technology has a solid future beyond the consumer segment,” said Rolf Nilsson, President at connectBlue.
“The opportunity to have wire-free equipment in a medical/surgical environment has its obvious advantages. For instance, an ECG may be sent via Bluetooth directly to a printer or internal camera images could be transmitted to a screen in the operating theater.”
Code Blue Communications, connectBlue’s product distributor for the North American medical industry, worked closely with Stryker Endoscopy to integrate the connectBlue solution into the control system. The company also acted in a consulting capacity throughout the system’s regulatory approval process.
Bill Saltzstein, founder and President of Code Blue Communications said, “As the regulatory body responsible for public health, the FDA’s primary concerns are safety and efficacy. To acquire FDA approval, a company must demonstrate that the system doesn’t interfere with other radio technologies or medical equipment present in the environment. The operating room is a particularly challenging environment with its sensitive devices and additional sources of RF emission.
“Securing marketing approval for the first Bluetooth medical application was a significant hurdle, and is based on excellent work by Stryker which establishes the precedent for many additional exciting applications in the future.”