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The agency said that manufacturers seeking certification for new products or maintaining existing certification may be affected by notified bodies that do not intend to transition to the new MDR, such as Lloyd’s Register and QS Zurich AG. Read More
“As opposed to traditional static interbodies, Prolift was engineered to reduce the need for surgical steps, such as sequential trialing, and in turn reduce operating time,” Life Spine said. Read More
The device applies a medical adhesive to close the diseased vein, using ultrasound to guide a catheter through the leg to the diseased area where it is then applied. Read More
Weeks ago, Edwards reported challenges in tracking and manipulating the Centera system around the aortic arch that led to vascular injury and death in some cases. Read More
According to the company, the device is the first product approved by the FDA that measures sagittal plane alignment in real-time without the heavy use of repeated imaging. Read More
The enhanced version of the assay has improved assay quality through the use of monoclonal antibodies and an enhanced resistance to potential interferences. Read More