Another FDA win for Synaptive Medical with its ImageDrive Pro

Synaptive Medical said it won FDA 510(k) clearance for its ImageDrive Pro informatics system designed to integrate its existing BrightMatter technology into multiple platforms.

The company said the new platform will allow for interoperability across all of BrightMatter’s solutions, including imaging, surgical planning, navigation and automated positioning of high definition optics.

BrightMatter gives 3D visuals of the brain in the operating room, which help guide surgeons as they pursue neurological procedures. During surgery, the images are placed over an anatomical scan, offering a way to visualize the inside of the brain.

“The need for deeper interconnectivity and integration of our own systems and data platforms is essential as we look at introducing novel imaging and sensing technologies in the near future. Our platform is uniquely designed to provide transformative data insights and make an impact in the continuum of care for patients undergoing various surgical treatments,” prez Cameron Piron said in a press release.

Toronto-based Synaptive Medical said its platform will allow for a more “unified experience” for interdisciplinary review through automated data distribution, de-identification and extensability using well-established protocols.

“Imaging data offers a ubiquitous snapshot that can quantify a patient’s response to various treatment and therapy protocolsWith data driven insights, we have the opportunity to accelerate quality care with efficient resource utilization, ultimately driving positive outcomes,” commercial head of informatics Brian Oswald said in a prepared statement.

“This is really just the beginning of where we want to go with imaging informatics. It will be the scaled amalgamation of varying data types combined with quantified imaging data that will enable the insights required to move toward a more personalized and precise model of care,” Piron said in a prepared release.

Last month, Synaptic Medical said it gained FDA clearance to start marketing its neurosurgery-specific surgical navigation tech for use in U.S. operating rooms.

The company said its BrightMatter Guide system cleared this regulatory sign-off after “months of review.” The company is also moving toward strategic expansion. Earlier in March, it bought up Clear Canvas for an undisclosed price, gaining access to its imaging informatics technologies and a customer base of about 30,000 healthcare professionals around the world.

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