Products

Surgical implant company RTI Surgical, Inc. has announced the full market launch of its Streamline® OCT System. The system is designed to promote fusion of the occipito-cervico-thoracic spine (or occiput-T3). RTI received U.S. FDA 510(k) clearance for the system in March 2014.

DePuy Synthes CMF has launched its new Patient Specific Plates for Mandible surgery, bringing a new level of accuracy to the procedure and avoiding the risk of bending-induced plate breakage.

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.

ulrich medical USA, Inc., has announced the U.S. market release of its tezo® spine implants for multiple surgical approaches to lumbosacral interbody fusion.

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.

By manufacturing customized implants, specifically pre-contoured using x-rays and proprietary software, surgeons can perfectly execute their surgical plans and accurately restore the sagittal alignment specific to each patient.

ConvaTec is claiming a first with the launch of its new ostomy pouch that brings the clinically-proven skin and leak protection of Moldable Technology to ostomates who prefer the convenience of a one-piece pouch.

Covidien plc has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.

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.

An emerging medical device manufacturing company (that we’d never come across until now), Advanced Cooling Therapy (ACT), has received CE marking for its first product, the Esophageal Cooling Device (ECD) to control patient temperature. The product is now available to medical professionals in Europe.

Ortho Development® Corporation has received FDA clearance for its Ovation Tribute™ Hip Stem. The Ovation Tribute is a femoral hip prosthesis that is intended for cementless use in total hip replacement and hemiarthroplasty procedures.

Medtronic has gained CE Mark approval for its Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System. The company says this is the first and only ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body.

Abiomed has received CE Mark approval to market its Impella RP device in the European Union, providing a non surgical heart support option for patients with reduced right ventricular function.