Obvius Robotics, a medical device company dedicated to democratizing vascular access, has announced its relocation to a new development and operations facility in South Florida.

This strategic move will support the company’s growth as it prepares for regulatory approval and commercialization of its innovative technology.

The company's pioneering technology requires minimal training and is initially aimed at central venous catheterization (CVC) procedures.

The CERTA Access System is a handheld, image-guided device that enables clinicians to accurately target anatomical structures and access them with the push of a button using a proprietary targeting system and needle assembly.

Early clinical use of the CERTA system has demonstrated a 100% success rate in accessing target sites (link).

As the most frequently performed interventional procedure in the United States, CVC is essential for treating critically ill patients and those undergoing surgery.

The procedure involves accessing a major vein (internal jugular, subclavian, or femoral) to place a multi-lumen catheter for rapid blood volume replacement, emergency medication administration, analgesic delivery, and hemodynamic monitoring. However, due to limited training and experience, CVC procedures have a complication rate of 4% to 11%.

“Our mission at Obvius Robotics is to democratize access, improve patient outcomes, and set a new standard of care in CVC”.

“The new facility will not only support the development and production of the CERTA Access System for CVC but will also be a center for innovation, allowing us to expand the CERTA platform into new applications.”

The CERTA Access System is currently not approved for clinical use, but the company is in the process of preparing its submission to the U.S. Food and Drug Administration (FDA) for market clearance.





Source: prnewswire.com

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