General Surgery

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.

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.

Clever little device this, a thing looking like a glorified cable-tie, but deliverable laparoscopically using a 5mm diameter instrument, all aimed at fixing hernia mesh in place securely and with minimal foreign body.

Robot surgery device specialist Intuitive Surgical, Inc., has announced the U.S. FDA clearance and introduction of the da Vinci Xi Surgical System, which it says represents a technological leap forward in replacing large-incision abdominal surgeries (open surgery) with a minimally invasive approach.

Israeli medical device company Medigus Ltd. has gained U.S. FDA 510(k) clearance for its next generation MUSE™ system, formerly known as the SRS™ system. Muse is a device which enables an incisionless procedure by performing an anterior partial fundoplication with standard surgical staples in a less invasive way.

Cardica, Inc. is trumpeting the first surgical procedure in the U.S. using its MicroCutter XCHANGE™ 30 cutting and stapling device, the only articulating five millimeter surgical stapler available today.

Pretty much a year after having gained the FDA’s nod for its Fortiva Porcine Dermis Patch, RTI Surgical Inc. has received CE mark approval for the product and says it will begin distribution throughout Europe.

Cardica, Inc. is a relative minnow in the world of minimally invasive surgical stapling devices. Now however it has announced two significant new FDA clearances that may well help it to compete with its rather bigger adversaries.

JustRight Surgical describes itself as a micro-laparoscopic medical device company devoted to miniaturizing surgical instrumentation. Now it has received FDA 510(k) clearance for its JustRight™ 5mm Stapler, a claimed first, aimed squarely at the pediatric surgeon.

Cook Medical’s EchoTip® ProCore™ Endobronchial Ultrasound Needle gives physicians the ability to retrieve both cell and tissue samples from lymph nodes or tumors in the pulmonary area.

Capsule Endoscopy company Given Imaging Ltd, has seen the U.S. FDA clear PillCam COLON as a new modality to provide visualization of the colon. PillCam COLON received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.

Abyrx™, Inc., has announced it has entered the soft tissue hemostasis market with a commercial deal with Chinese company Haibo Biotechnology Institute’s (HBI) proprietary resorbable plant-derived soft tissue hemostat technology platform.

In what is claimed to be the largest in the world on surgical simulation for robotic surgery, an Italian team has concluded that aptitude on virtual reality tests can provide a measure of innate ability or as they term it, manipulative and psychomotor skills.

daVinci company Intuitive Surgical is to acquire a “shape-sensing” technology from its developer, Luna Innovations Inc. in a deal worth up to $30 million.

Covidien has received U.S. FDA 510(k) clearance for the LigaSure™ Maryland jaw open/laparoscopic sealer/divider. In addition the company has completed all European requirements to CE Mark the product. It expects to launch the new vessel sealer and divider in the United States and the European Union during the current quarter.

The U.S. FDA has allowed Xlumena’s AXIOS Stent onto the market under its de novo pathway. AXIOS is the first stent that is specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.