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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FDA reviewers expressed concern with the increased number of cancer cases seen in degenerative disc disease patients implanted with an investigational Medtronic spine device compared with patients who underwent spinal fusion. The Amplify device stabilizes lower back vertebrae in patients with degenerative disc disease by using a compression resistant matrix and a metallic posterior spinal instrument. Amplify contains rhBMP-2, a morphogenetic protein that is added to the device to spur the formation of new bone.

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The FDA initiated a class I recall its strictest of two infusion pumps released by a single company, due to a device error which may fail to recognize in-line air in infusions. Device manufacturer Hospira warned that failure to make corrective actions before device use may cause air to be delivered to the patient and cause serious injury or death. The company has not received any adverse event reports related to device failure.

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The FDA has laid out requirements for the recall of Colleague Volumetric Infusion pumps by Baxter Healthcare Corp., instructing the company on how to refund or provide replacements for about 200,000 potentially dangerous infusion pumps. The FDA announced the infusion pump recall requirements, a little more than two months after it announced that Baxter would be forced to take its Colleague pump off of the market. Problems with Baxter Colleague infusion pumps have been linked to more than 500 deaths and 56,000 reports of adverse events.

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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.

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.

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.