• BSD Medical (Salt Lake City) said that it has provided the additional data requested by the FDA pertaining to its 510(k) premarket notification submission for the MicroThermX-100 microwave ablation system. BSD Medical's product line includes systems that have been strategically designed to offer a range of thermal treatment products using microwave and radio frequency technology. It said it is the leading developer of hyperthermia systems used to treat cancer using heat to increase the effectiveness of companion radiation therapy. The MicroThermX-100 microwave ablation system represents an expansion of BSD's products into new applications, as the MicroThermX-100 is designed as a stand-alone therapy that is used to ablate diseased tissue using heat alone.

• Conmed Linvatec's (Utica, New York) arthroscopy unit received FDA clearance for marketing of the Bio Mini-Revo suture anchor for use in the repair of the labrum in the hip joint. The hip labrum is a form of cartilage that lines the rim of the socket of the hip. Torn and detached labral tissue is associated with hip pain during movement. In an arthroscopic technique, surgeons use suture anchors to reattach the torn cartilage to the rim of the socket to relieve pain and regain normal hip function. The Bio Mini-Revo anchor is a bioabsorbable 3.1 mm diameter screw-in anchor manufactured from Conmed Linvatec's self-reinforced 96L/4D Poly Lactic Acid. This material provides what the company terms an "optimal balance of strength (during the initial healing period post-surgery) with enhanced resorption over time, negating the need for a second surgery to remove the implant." The anchor is pre-threaded with #2 Hi-Fi high-strength sutures. Conmed makes surgical devices and equipment for minimally invasive procedures and monitoring.

• Duramed Pharmaceuticals (Pomona, New York) said that its AmniScreen product is the first and only FDA-approved at-home screening test for amniotic fluid leakage during pregnancy, a condition that may lead to serious complications such as infection and pre-term labor. AmniScreen is available by prescription and can be purchased in retail pharmacies. AmniScreen is a panty liner test that offers at-home screening for pregnant women who experience unexplained vaginal wetness. One AmniScreen test kit contains three panty liners and three drying trays.

• Iridex (Mountain View, California) reported receipt of FDA 510(k) clearance for its family of Iridex IQ laser systems. This clearance covers the Iridex IQ 532, IQ 577, IQ 630-670, and IQ 810 laser systems and their associated delivery devices to deliver laser energy in either CW-Pulse, MicroPulse or LongPulse mode. These laser systems are intended for a wide range of specific applications in the medical specialties of ophthalmology, ear, nose and throat (ENT)/otolaryngology, and dermatology. MicroPulse mode can be viewed simply as a CW-Pulse that has been "chopped," with brief Laser Off intervals distributed uniformly over the CW-Pulse duration. The time interval between pulses provides time for the thermal energy to dissipate and slow the temperature elevation in the treated area. Iridex makes therapeutic-based laser systems, disposable laser probes and delivery devices to treat eye diseases in ophthalmology and skin disorders in the aesthetics market.

• NewCardio (Santa Clara, California) revealed the results of its third external validation study of QTinno. The study evaluated the accuracy, precision and speed of OTinno, in producing fully automated measurements of drug-induced QT prolongation, a key cardiac safety indicator. Such data is now required by drug regulatory bodies worldwide for all new drugs in development, and at present must be obtained by expensive and time-consuming manual or semi-automated methods. QTinno is a software suite that provides automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. Its key features include full automation with minimal to no human intervention required, improving the productivity, accuracy and precision of clinical trials, the company said. NewCardio said it believes QTinno is equal to the best manual assessments and is able to provide high-quality quantitative data from a broad range of difficult-to-read ECGs. NewCardio is a cardiac diagnostic and services company focused on the development of platform technology to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram.

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