Two of the giants of the orthopedic industry are to become one, with the news that Zimmer and Biomet's board have agreed to an acquisition. Biomet will cost Zimmer a reported $13.35 Billion, and will still be accretive in its first year.
Medtronic recently gained the FDA's nod to commence its IDE study into Evera, and the device has now seen its first implant performed, as part of the Medtronic randomized, global pivotal clinical trial that will enroll up to 275 patients at approximately 45 centers.
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.
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.
Two of last week's news items have moved on a bit over the Easter weekend: Medtronic's increasingly acrimonious spat with Edwards over the respective companies' transcatheter heart valve offerings, and Covidien's recall being graded Class I by the FDA.
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.
St. Jude is sounding punchy, expecting revenue gains based on a flurry of new product approvals.
Interventional Pulmonology company Pulmonx points us at a poster about its Zephyr® Endobronchial Valve (EBV). The poster was featured at the 18th World Congress for Bronchology and Interventional Pulmonology (WCBIP) in Kyoto, Japan.
EndoGastric Solutions® (EGS), says newly released data demonstrates that its Transoral Incisionless Fundoplication (TIF®) procedure outperforms proton pump inhibitor (PPI) treatment, while achieving similar normalization rates of distal esophageal acid exposure.
Medline Industries, Inc. has announced its acquisition of the anterior cervical fusion distraction pin business from Amendia, a recognized leading provider of innovative Class II and Class III medical devices used in spinal surgical procedures.
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.
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.
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.