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Acumed® Introduces New Polarus® 3 Solution for Proximal Humerus Fractures

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


Zimmer to Buy Biomet

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.

First U.S. Implant of Full-Body MRI-Compatible ICD in IDE Study

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.

Newly FDA Cleared da Vinci Sp Single Port System Will See 2015 Launch

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.

CE Mark Means Patients with EndoStim LES Can Now Undergo MRI Scans

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.

CE Mark for Z-Lig™Based on Clinical Success for Porcine-Derived ACL Replacement Device

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.

Catch-up: Medtronic Wins CoreValve Stay and Covidien’s Pipeline Recall Gets FDA Class

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.

FDA Clearance for Breathe Technologies’ NIOV System for use with Compressed Gas

Headline imageBreathe 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 Financials Show Revenue and Earnings Growth and Promise More of the Same

St. Jude is sounding punchy, expecting revenue gains based on a flurry of new product approvals.

Poster Points to Improved Lung Function with Pulmonx Endobronchial Valve Therapy

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.

TIF® Procedure Easily Outperforms Proton Pump Inhibitor Therapy at 6 Months

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 Buys Amendia’s Cervical Fusion Distraction Pin Business

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.

FDA Approves Cochlear’s Aqua+ Accessory, Making Nucleus® the World’s Most Waterproof Cochlear Implant

Headline imageCochlear 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.

Newly Launched RTI Surgical™ Streamline® OCT System Offers More Screw Placement Options

Headline imageSurgical 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.

New Mandible Plate “Seamlessly Integrates Surgical Planning, Intraoperative Tools and Patient Specific Devices

Headline imageDePuy 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.

Triple Whammy of Global Device Approvals for Zip® Surgical Skin Closure

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.