Products

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

Argon Medical Devices, Inc. unveiled its CLEANERXT™ Rotational Thrombectomy System at the recent 2014 Society of Interventional Radiology meeting in San Diego. Now the company tells us it has begun marketing the system, which is a new addition to the CLEANER family of dialysis products.

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.

Endoscopic imaging specialist PENTAX Medical Company, has announced the U.S. and Canada launch of the endoPRO iQ® 7.6, the company’s newest version of its information technology (IT) and image management software for endoscopy units.

HeartWare International has issued another warning to its customers. This time its a voluntary Urgent Medical Device Correction related to all HeartWare® Ventricular Assist System batteries, product codes 1650 and 1650-DE.

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.

A new initiative, funded by the European Commission, is targeting a radical improvement in the performance of surgical lighting and medical video systems.

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.

No doubt timed to coincide with the FDA’s Class I recall notice, HeartWare International, Inc. has itself issued a clinician and patient reminder concerning last December’s Urgent Medical Device Correction relating to its Ventricular Assist System.

Designed to make for a simplified operating room experience, this new system includes both plates and nails that share the same instrumentation and screws.

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.