CLEVELAND–(BUSINESS WIRE)–Centerline Biomedical, Inc. (“Centerline”), an innovative leader in cardiovascular navigation and visualization systems, announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance of expanded indications for its Intra-Operative Positioning System (IOPS). This news is complemented by the recent 510(k) clearance of the IOPS Fiducial […]
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Centerline Biomedical receives FDA 510(k) clearance for new IOPS® Viewpoint Catheter, further addressing market need to reduce physician exposure to harmful x-ray radiation during image-guided, endovascular procedures
CLEVELAND, Aug. 6, 2024 /PRNewswire/ — Centerline Biomedical, Inc. (“Centerline”), an innovation leader in cardiovascular navigation and visualization systems, announced today that the IOPS Viewpoint Catheter has received US Food and Drug Administration (FDA) 510(k) clearance. The…
Centerline Biomedical joins ORSIF
Centerline Biomedical and ORSIF join together to raise awareness of health risks associated with fluoroscopic radiation and solutions available to medical professionals.
CLEVELAND, July 9, 2024 /PRNewswire/ — Centerline Biomedical, Inc. (“Centerline”), joins ORSIF, the organization for Occupational Radiation Safety in International Fluoroscopy, to raise awareness of technology options to improve safety in the work environment where fluoroscopic x-ray radiation is used in medical procedures. As a corporate partner, Centerline supports ORSIF (www.orsif.org) in a shared mission to champion innovation for safer healthcare. In addition, the developing platform aims to continue bringing together healthcare providers and their organizations, professional medical societies, and industry to provide education on radiation safety.
“We are proud to join ORSIF in its mission to create greater awareness in the medical community regarding the dangers of radiation exposure and to protect those who commit their lives to the wellness of others. To that end, IOPS® (Intra-Operative Positioning System) technology enables improved visualization with 3D navigation in endovascular procedures while minimizing the reliance on damaging radiation,” said Gulam Khan, CEO of Centerline Biomedical. “Employees at Centerline are inspired every day to design the future of image guidance technology that enables faster, more precise transcatheter procedures while reducing the use of radiation.”
Designed to mitigate radiation exposure during minimally invasive cardiovascular procedures, Centerline Biomedical IOPS (Intra-Operative Positioning System) is a novel technology gaining increased application in the US. IOPS includes software that creates 3D maps of vascular anatomy, enabling surgeons to visualize the arteries being treated. Using electromagnetic tracking, IOPS sensor-equipped guidewires and catheters can be guided in 3D as endovascular specialists navigate through these high-resolution intuitive visualizations during minimally invasive procedures. The images and tracking are displayed on an independent monitor, minimizing the reliance on damaging X-ray radiation typically used to produce live fluoroscopic images during interventions.
About Centerline BiomedicalFounded in 2015, Centerline Biomedical is headquartered in Cleveland, Ohio. The company’s commercially available platform, IOPS®, Intra-Operative Positioning System, enables improved visualization and navigation in endovascular procedures. IOPS has 510(k) clearance from the US FDA for use in the descending aorta. The company continues investment in development to enhance the current technology platform and expand image guidance in transcatheter procedure applications.
Visit www.centerlinebiomedical.com for more information.
SOURCE Centerline Biomedical
Centerline Biomedical announces Gulam Khan as Chief Executive Officer
CLEVELAND, Oct. 4, 2022 /PRNewswire/ — Centerline Biomedical, Inc. (“Centerline”), which recently commercialized its Intra-Operative Positioning Systems IOPS®, has appointed Gulam Khan, Chief Executive Officer. Mr. Khan has more than two decades of executive leadership experience, including serving as the President and CEO of Mentor, Ohio-based US Endoscopy and serving as the Senior Vice […]
Centerline Biomedical Raises $33 Million in Series B Financing
Proceeds will accelerate a robust R&D pipeline, commercial partnerships and clinical activities led by leading institutional and strategic investors CLEVELAND, June 27, 2022 /PRNewswire/ — Centerline Biomedical, Inc. (Centerline), a private medical technology company, announced the closing of a $33 million Series B equity financing led by Cleveland Clinic with participation by GE Healthcare, […]
Centerline Biomedical Announces Successful Structural Heart Animal Study
Centerline Biomedical executes animal study demonstrating 4D augmented reality navigation through complex structures of the heart CLEVELAND , May 19, 2022 /PRNewswire/ — Centerline Biomedical, Inc. (Centerline) announced Thursday the completion of the second in a series of structural heart navigation animal studies. Physicians from Cleveland Clinic’s top-ranked Heart, Vascular and Thoracic Institute […]
Centerline Biomedical Adds Two Expert Advisors to Advance New Clinical Applications
Dr. Azeem Latib and Doug Teany join to bring deep subject matter expertise in coronary and structural heart procedures as well as robotic surgery CLEVELAND, June 21, 2021 /PRNewswire/ — Centerline Biomedical, Inc. (Centerline), a spinoff of Cleveland Clinic, today announced the appointment of two key advisors. As Centerline launches its flagship Intra-Operative […]
Centerline Biomedical Kicks Off First Clinical Study of Intra-Operative Positioning System Technology
First surgical case launches multicenter prospective clinical study of FDA-cleared product to support international market entry CLEVELAND, Dec. 15, 2020 /PRNewswire/ — Centerline Biomedical, Inc. (Centerline) announced Tuesday the completion of the first surgical case in its MOTION clinical study of its innovative Intra-Operative Positioning System (IOPS™) surgical navigation platform. The FDA-cleared […]
Centerline Biomedical Completes First Human Patient in the United States with IOPS™ (Intra-Operative Positioning System)
Fast-growing startup company continues to execute key milestones and begins first in-market use of novel endovascular navigation technology CLEVELAND, May 4, 2020 /PRNewswire/ — Surgical navigation startup Centerline Biomedical, Inc. (Centerline), a Cleveland Clinic spin-off company, has announced the successful completion of the first in a series clinical cases in the United States as […]
Centerline Biomedical Announces FDA Submission for IOPS System
CLEVELAND, Jan. 24, 2019 /PRNewswire/ — Centerline Biomedical, Inc., announced on January 22nd that the company submitted a 510(k) premarket notification application to the United States Food and Drug Administration (FDA) for its flagship product, the Intra-Operative Positioning System, IOPS. IOPS, a non-radiation-based surgical navigation system for minimally invasive surgery, leverages anatomical mapping and modeling […]