South Korea-based Medyssey Co., Ltd. announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Zenius(TM) Thoracolumbar Spinal System. Though currently available in limited release, Medyssey will launch the new Zenius(TM) System in the United States in Q4. The Zenius(TM) System is a Ti alloy 5.5 mm Rod and Thoracolumbar Pedicle Screw Construct for the surgical treatment of spinal trauma, deformity, and degenerative spinal pathologies.

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NuOrtho Surgical, a surgical instrument developer based at the Advanced Technology and Manufacturing Center, has received FDA clearance to market its surgical probe. The approved probe, called Ceruleau, is NuOrtho’s first device to hit the market. NuOrtho received FDA clearance sooner than expected, Jeffrey Morrill, NuOrtho’s CEO, said. The company is now working to ramp up manufacturing and line up distributors. Within the next few months, as Ceruleau hits the market, the small company plans to hire about 20 people.
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Israel’s PolyTouch Medical has received FDA clearance to market its PatchAssist laparoscopic hernia mesh placement device. The tool was developed to allow surgeons a more predictable and standardized approach to apply hernia patches. PatchAssist easily unfolds the mesh inside the abdominal cavity, accurately places the mesh over the hernia defect and enables surgeon to verify the mesh position before attachment is made. Patch Assist does not change laparoscopic techniques used today by surgeons, rather it eliminates manual, complicated, and time consuming tasks.

PolyTouch Medical Ltd. has announced that it has received broad FDA 510(k) clearance to commercialize PatchAssist(TM). PatchAssist is an innovative laparoscopic surgical instrument that enables accurate and rapid delivery and placement of soft tissue prosthetics for a variety of procedures, including laparoscopic ventral hernia repair (LVHR). PatchAssist enables surgeons to rapidly deliver and position soft tissue prosthetics over the defect potentially reducing operation time by 30% – 50%.

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SafeStitch Medical, Inc. has announced that it has received 510(k) clearance from the FDA to market its AMID StaplerTM in the U.S. with the intended use in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissues, including skin. The AMID Stapler™ is the first surgical stapler designed specifically for use in inguinal hernia repairs.

Irvine-based Endologix has received Investigational Device Exemption conditional approval from the U.S. Food and Drug Administration to begin a clinical trial for a fully percutaneous approach to endovascular abdominal aortic aneurysm repair. The authorization allows the minimally invasive device maker to test the procedure using its IntuiTrak endovascular delivery system. AAA is a weakening of the walls of the aorta, which is the largest artery in the body.

CryoLife, Inc. has announced that the FDA has approved the company’s Investigational Device Exemption to conduct a human clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology.  BioFoam will be used to seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent.

Collagen Matrix Inc has received the FDA’s 510(k) clearance for its new Collagen Dental Membrane indicated for use in oral surgical procedures involving guided tissue and bone regeneration. This new Collagen Dental Membrane is a non-friable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from bovine dermis.

Bovie Medical Corp has received clearance to sell a device that cuts and reseals tissue in kidney surgeries. The FDA has approved market of Bovie’s laparoscopic SEER device, which is used for cutting and coagulating soft tissue. It is intended to be used in partial removal of kidneys. Bovie said the laparoscopic SEER, or Saline Enhance Electrosurgical Resection, device is an extension a line the company launched earlier this year.

Covidien has received clearance from the FDA to market a medical device, called the Mallinckrodt TaperGuard Evac endotracheal tube, created to reduce the risk of postsurgical complications caused by the aspiration of fluids into the lungs. Although complications from pulmonary aspiration are rare, the consequences can be severe, Covidien said.