Bausch + Lomb, of Bridgewater, N.J., received U.S. FDA 510(k) clearance for use of the Tangible Hydra-PEG custom contact lens coating technology on Boston gas permeable (GP) materials – the Boston XO, Boston XO2, Boston EO and Boston ES lenses – including those utilized in the Zenlens scleral lens family. Designed to address contact lens discomfort and dryness, the Tangible Hydra-PEG is a high-water polymer coating that is bonded to the surface of a contact lens.
Flower Orthopedics Corp., of Horsham, Pa., reported two additions to its Ready-for-Surgery product line: the Flower Jones Screw and the 6.5 mm Headless Compression Screw. These two screw systems provide new indications for surgeons to utilize the Flowercube, increase efficiency and minimize infection potential. Each system will be featured at the upcoming American College of Foot & Ankle Surgeons Conference.
Integra Lifesciences Holdings Corp., of Plainsboro, N.J., launched the Integra Panta 2 TTC arthrodesis nail system for tibio-talo-calcaneal (TTC) fusion of the ankle due to severe arthritis. Panta 2's new carbon fiber targeting and compression device offers surgeons an unobstructed view intraoperatively of the Panta 2 nail for improved visibility for positioning and identification that bone-to-bone contact has been achieved. With up to 12 mm of compression for patients of varying anatomy, the Panta 2 instrumentation and implants are designed to achieve fusion of the TTC joint.
SpeeDx Pty. Ltd., of Sydney, said it submitted its PlexPCR Respivirus test to the Therapeutic Goods Administration. The company anticipates clearance in time for the Australian 2019 flu season. The test utilizes SpeeDx's PlexPCR multiplex technology, designed for detection of 14 targets representing 10 viral respiratory-illness causing pathogens. The SpeeDx PlexPCR Respivirus test detects major respiratory pathogens including influenza A, influenza B, rhinoviruses (A & B), respiratory syncytial viruses (A & B), human metapneumovirus, adenoviruses, and human parainfluenza viruses 1, 2, 3 and 4.
Vapotherm Inc., Exeter, N.H.-based developer of Hi-vni technology products for the treatment of respiratory distress, reported the launch of the next generation of its Precision Flow Hi-vni system. According to the company, both the hardware and software have been updated to improve reliability. Additionally the device complies with the EMC 4th Edition requirements for medical devices, IEC 60601-1-2:2014. Hi-vni technology is mask-free noninvasive ventilation for spontaneously breathing patients. While being treated, patients can talk, eat, drink and take medication.