TYRX, Inc. introduces AIGISRx® ST, its antibacterial product for the surgical repair of damaged or ruptured soft tissue. TYRX had previously received 510(k) clearance to market a product for hernia repair and other abdominal soft tissue deficiencies. The new clearance adds the use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue.

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Integra LifeSciences Holdings Corporation has announced the introduction of a new line of extended length and “detachable” Ruggles(TM) kerrison rongeurs, which are key instruments used in a variety of neuro and spine surgeries. The Ruggles(TM) kerrison rongeurs with a detachable feature received 510(k) clearance from the United States Food and Drug Administration (FDA). The new feature allows for easier cleaning, and special coatings help preserve the instrument’s sharpness.

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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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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.