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.

The FDA is reconsidering the approval of ReGen Biologics Inc’s knee device after an investigation showed that unprecedented industry and Congressional involvement influenced the agency’s decision. Joshua Sharfstein, the agency’s principal deputy commissioner, said, however, that patients who have had Menaflex implanted in their knee need not panic and noted that the device is still on the market. ReGen Chief Executive Gerald Bisbee said in a statement that the report didn’t evaluate the scientific evidence about the device. The company said the product is safe and helps knee-surgery patients recover more quickly.

The FDA has approved Cochlear’s Nucleus 5 System for adults and children with severe-to-profound hearing loss. The Nucleus 5 System is the only one of its kind on the market today that offers the smallest, most water resistant sound processor, the thinnest titanium cochlear implant, two-way remote assistant, SmartSound((TM)) 2 technology and AutoPhone (TM) capability.

Covidien received 510(k) clearance from the FDA to market its Leak Compensation software feature for the Puritan Bennett 840™ ventilator system. This option provides continuous levels of mechanical ventilation to patients requiring respiratory support, regardless of the level of gas leakage that might occur in the circuit or past a patient interface device in the clinical setting.

Cardinal Health Inc has received FDA clearance to resume shipments of its flagship line of infusion pumps after problems triggered a halt to shipping earlier this year. The company had put the shipping of the patient-controlled modules for the pumps, which allow a patient to press a button for pain medication, on hold in March. It would now immediately resume customer implementations of its Alaris(R) PC units and PCA (Patient Controlled Analgesia) modules.