• Evera Medical (Foster City, California) said the FDA has granted conditional approval of its investigational device exemption application for its FulFil Lip cosmetic augmentation implant. This approval allows Evera Medical to assess the safety and effectiveness of the FulFil Lip implant in patients undergoing aesthetic lip enhancement. FulFil Lip consists of a very thin, stretchy balloon, which when filled with saline, is designed to replicate the natural look and feel of youthful lips. The implant can be adjusted until the desired degree of enhancement is achieved. Once the implant is placed in the lip, a micro-valve prevents fluid from escaping. A thin coating allows gentle attachment to the lip tissue, without excessive scarring or firmness. Evera Medical makes soft-tissue implants for cosmetic and non-cosmetic applications.

• Sonic Innovations (Salt Lake City) reported the launch of a new series of Velocity brand hearing aids: Velocity 24, Velocity 12 and Velocity 4. Velocity 24 is designed for patients who are constantly in challenging listening environments that typically include background noise. Velocity 24 features automatic and adaptive directionality, adaptive feedback cancellation and automatic noise reduction. Velocity 12 is designed for patients who encounter situations that may include background noise. It features automatic and adaptive directionality, adaptive feedback cancellation and noise reduction. Velocity 4 offers basic features that can help patients hear better in many situations. It features directionality, feedback cancellation and noise reduction.

• Zoll Medical (Chelmsford, Massachusetts) said it has been notified of Airworthiness Release by the U.S. Army's Research, Development and Engineering Command for the Zoll AED Pro A-W. The certification indicates that the AED Pro A-W is in compliance with Department of Defense medical device certification criteria and is certified for use aboard Medevac helicopters. The AED Pro features a 1.5-meter drop test to withstand "pounding rain, searing heat, freezing cold and significant drops." It provides CPR Help for gauging the rate and depth of CPR chest compressions to assist caregivers in improving CPR quality. And its See-Thru CPR allows the rescuer to view a patient's underlying cardiac rhythm, by filtering CPR artifact, during resuscitation and eliminating the need to stop compressions to see if defibrillation was successful. Zoll makes resuscitation products.

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