Approvals

CSA Medical Wins Expanded FDA Clearance for TruFreeze Cryotherapy

CSA Medical won expanded 510(k) clearance for its TruFreeze spray cryotherapy system.

The system is now cleared for use on patients with Barrett’s esophagus with low grade dysplasia. The device was previously approved for high grade dysplasia as well as malignancies, the Boston-based company said.

The TruFreeze system is designed for use in dermatology, gynecology, general surgery and to ablate benign and malignant lesions.

Dextera Surgical Gets Expanded Clearance for MicroCutter 5/80 Stapler

Dextera Surgical won expanded FDA 510(k) clearance for its MicroCutter 5/80 stapler and associated reloads, now cleared for open solid organ dissection techniques. The new clearance covers use on organs including the liver, kidney, pancreas and spleen.

The device is designed for transection and resection procedures in multiple open or minimally invasive urologic, thoracic and pediatric surgical procedures or creation of anastomoses in the small and large intestine and the transection of the appendix.

The expanded indication represents an additional 44,000 procedures in the United States annually.

Leica Wins FDA Clearance for Novel Microscopy Filter

Leica Microsystems won FDA clearance for its FL560 fluorescence microscope filter for use with the dye fluorescein to view cerebrovascular blood flow.

The device works with the M530 OH6 neurosurgical microscope. After injection of fluorescein, the surgical team can see blood fluorescing in greenish/yellow, providing contrast between the blood flow and surrounding anatomy so both can be seen.

Using two illumination methods, the device can treat fluorescence differently than white light.

Gecko Biomedical Receives CE Mark for SETALUM Sealant

Gecko Biomedical received a CE Mark for its SETALUM Sealant.

The bioresorbable sealant can be used as an add-on to sutures during vascular surgery. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.

The CE Mark is the first regulatory validation of the company’s polymer platform.

Migraine Treatment Device Wins Marketing Clearance

Devicemaker eNeura received 510(k) clearance from the FDA for the eNeura Spring TMS for treatment of migraine headache.

The prescription-only device uses single-pulse transcranial magnetic stimulation to induce a mild electric current that modulates nerve cells in the brain. Patients push a button to deliver a magnetic pulse to treat a migraine attack and or to prevent the onset of future migraine attacks.

SpringTMS has CE Marking in Europe for the acute treatment of migraine and migraine prevention.

ClaroNav Wins 510(k) Clearance for NaviENT Surgical Navigation System

ClaroNav won FDA 510(k) clearance for its NaviENT surgical navigation system designed for endoscopic sinus and skull base surgery.

The image-guided surgical navigation system helps surgeons identify complex anatomic structures.

ClaroNav plans to launch the product in the U.S. in the coming months. The device had previously been granted CE mark approval for the European market and Health Canada approval in 2016.

NuVasive Receives 510(k) Clearance for Pediatric Implant

The FDA cleared NuVasive’s redesigned Magec system with its Reline Small Stature system for pediatric use.

The Magec system uses magnets within adjustable growing rods to treat early-onset scoliosis. Reline Small Stature is a designed to provide optimal strength with a reduced implant profile.

The device is the only small stature system compatible with the 5.0 millimeter Magec rod.