Approval/Clearance

Orthobiologics company BioStructures, LLC, has seen its Signafuse™ Bioactive Bone Graft Putty granted U.S.FDA 510(k) clearance. Signafuse™ is indicated for the posterolateral spine, extremities and pelvis as well as a bone graft extender in the posterolateral spine.

Last year it gained CE mark approval for it’s MIS non-pedicle screw spinal fusion system. Now Aurora Spine has gained Australia’s green light in the form of a TGA clearance to market the device.

It’s been pretty quite in Renal Denervation territory since the January bombshell of Symplicity HTN-3 clinical outcomes. Nonetheless, one company, Cordis, has pushed ahead with its CE marking and now been granted its EU approval.

Cyberonics, Inc. has gained CE Mark approval for its AspireSR generator, the novel sixth-generation Vagus Nerve Stimulation (VNS) Therapy generator.

Parametric Sound Corporation, a leading innovator of audio products and solutions, has received U.S. FDA clearance for the marketing of its HyperSound® Audio System as a hearing improvement device.

Medtronic is launching its tiny Reveal LINQ heart monitor globally following U.S. FDA and Euroepan CE mark clearance. The Reveal LINQ Insertable Cardiac Monitor (ICM) System is a five times smaller than the previous smallest implantable cardiac monitoring device

A range of silicone breast implants with integrated RFID technology has been CE Marked. This means key data about the implants can be easily retrieved with the sweep of a scanner, rather than resorting to hospital records in the event of a recall or other clinical need.

Reverse Medical Corporation, a frequent visitor to our pages, has announced CE Mark and the initial clinical use of the UNO™ Neurovascular Embolization System for intracranial use in obstructing blood flow in the Neurovasculature.

Integrity Life Sciences has announced the U.S. FDA clearance of a new version of its Integrity Spinal Care System (ISCS), a non-surgical medical device that applies therapeutic distraction forces to a patient’s spinal column to alleviate low back and neck pain for a broad range of spinal disorders.

Boston Scientific Corporation has received CE Mark approval for its WallFlex™ Esophageal Fully Covered Stent to treat refractory benign esophageal strictures.

Hospi Corporation has gained FDA 510(k) clearance for its first product, the Macy Catheter™. The Macy Catheter is the only device designed and approved solely for ongoing rectal delivery of medications and liquids.

JustRight Surgical describes itself as a micro-laparoscopic medical device company devoted to miniaturizing surgical instrumentation. Now it has received FDA 510(k) clearance for its JustRight™ 5mm Stapler, a claimed first, aimed squarely at the pediatric surgeon.

With its newly announced CE mark, Tryton Medical has become the purveyor of the first & only coronary bifurcation stent indicated for Left Main Coronary artery application.

This is the first time we’ve ventured out into the world of aesthetic treatments, with the news that the FDA has given its blessing to a device that exploits the benefits of different forms of light to effect hair removal.

Californian spinal implant maker Interventional Spine, Inc. has seen eleven additional sizes of its Opticage™ Expandable Interbody Fusion Device cleared by the U.S.FDA. The company says these new sizes will allow surgeons to match an Expandable Opticage to more than 80% of their patients requiring Lumbar Fusion surgery.

Aurora Spine Corporation has gained U.S. FDA 510(k) clearance for its sterile-packed TiNano™ titanium plasma spray coated spinal fusion implants.