Approval/Clearance

Medtronic, Inc. has gained CE Mark approval and will now launch its newest cardiac resynchronization therapy-pacemaker, Viva® CRT-P in Europe.

It’s Digestive Disease (DDW) 2014 this week in Chicago, IL. and Olympus has chosen the event at which to launch its newly cleared “next-generation” ENDOCAPSULE 10 System for small bowel capsule endoscopy procedures.

Acutus Medical has pioneered an innovative approach in the minimally invasive imaging and mapping of cardiac arrhythmias. Now the company has announced the gaining of CE Mark approval for its proprietary real-time 3D diagnostic imaging and dipole density mapping catheter.

Italian Cardiovascular company Sorin Group, has received U.S. FDA approval for the Mitroflow Aortic Pericardial Heart Valve with Phospholipid Reduction Treatment (PRT).

GS Medical USA, LLC, tells us that its AnyPlus® T/PLIF Cage has received U.S. FDA 510(k) clearance. The new system expands the Company’s successful AnyPlus® platform of cages and will now see its U.S. launch.

CrossBay Medical, Inc., has announced a bevvy of regulatory clearances. The company’s SonoSure™ Sonohysterography and Endometrial Sampling Device now has U.S.FDA and Health Canada clearance as well as CE mark approval.

Robotic surgery specialist, Intuitive Surgical, Inc, says it has received U.S. FDA 510(k) clearance for the da Vinci Sp Surgical System, which is designed to expand the Company’s single-incision product offering. This initial clearance is specific to urologic surgical procedures that are appropriate for a single port approach.

The EndoStim LES Stimulation System has received CE Mark approval for use with Magnetic Resonance Imaging (MRI), and is now conditionally approved for MRI scans of head and extremities.

Cochlear Limited, the global leader in implantable hearing solutions, has announced that the U.S. FDA has approved the Aqua+ accessory, the only waterproof behind-the-ear solution for cochlear implant recipients on the market today.

The CE marking of Aperion Biologics, Inc.’s lead product, the Z-Lig™ device makes it the first engineered biological device to gain approval for revision and multiligament ACL reconstruction.

Breathe Technologies, Inc. has announced the U.S. FDA 510(k) clearance of its Non-Invasive Open Ventilation (NIOV) System, opening up the potential for it to be used with a compressed air supply for non-oxygen dependent patients.

ZipLine Medical says its Zip® Non-invasive surgical skin closure device is faster than sutures, can produce superior cosmesis compared to staples and reduce the risk of surgical site infection.

Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices, including the DYNAGEN™ MINI and INOGEN™ MINI ICDs, as well as the DYNAGEN™ X4 and INOGEN™ X4 CRT-Ds.

Reverse Medical® Corporation has gained FDA IDE approval for clinical investigation of its BARREL® Vascular Reconstruction Device (VRD). The BARREL® Vascular Reconstruction Device is designed for use with occlusive devices in the treatment of intracranial bifurcation aneurysms.

Covidien plc has gained U.S. FDA 510(k) Clearance for its Kangaroo™ feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing visualization for a procedure that is currently blinded.

Last month implantable hearing solutions expert, Cochlear Ltd., gained U.S. FDA approval for its Cochlear™ Nucleus® Hybrid Implant System. Now the FDA has issued its own information summary about the device.