Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Synergetics Retinal Surgery Devices Received FDA Clearance - Medical Product Outsourcing

What are you searching for?

Sign in

Synergetics Retinal Surgery Devices Received FDA Clearance

The device is under review for the CE Mark.

By: Niki Arrowsmith

NULL

Synergetics USA Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT, a vitrectomy system for retinal surgery. A vitrectomy is a procedure by which all the vitreous humor is removed from the eyeball in order to treat a variety of conditions.

Synergetics is based in O’Fallon, Mo., and is a manufacturer of microsurgical devices for ophthalmic and neurosurgical applications.

“The entry of VersaVIT into the global vitrectomy market is a major milestone in Synergetics’ strategy to enter into higher growth areas of retinal surgery,” said David M. Hable, president and CEO of the company. “We believe that VersaVIT is a ‘game changer’ given its functionality, portability and competitive pricing relative to traditional vitrectomy systems.”

The company is awaiting CE Mark approval in Europe, which has been submitted and is currently under review.






Add us as a preferred source on Google

Get the latest Medical Product Outsourcing news, insights and analysis in your Google Search and AI experiences.

Add Medical Product Outsourcing as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters