Centerline submits 510(k) for navigation system

Centerline Biomedical has submitted a 510(k) application with the U.S. Food and Drug Administration (FDA) for its Intra-Operative Positioning System (IOPS), which the company sees as a potential alternative to fluoroscopy for intraoperative navigation.

IOPS is a nonradiation-based surgical navigation system for use in minimally invasive surgery that employs anatomical mapping and modeling algorithms with electromagnetic tracking technology. It provides 3D color visualization and real-time guidance during endovascular procedures.

Centerline said that IOPS will turn patient scans into mathematical representations that can facilitate computational applications. The company will initially apply the technology to surgical navigation, but it anticipates using the data as the basis of a cloud-based platform that supports clinicians.

Once it receives FDA clearance, Centerline plans to market IOPS for endovascular aortic interventions. It is also in the process of raising a series B round of funding and has hired a new CEO, Mark Modica. IOPS was developed at the Cleveland Clinic's Heart and Vascular Institute.

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