• Aurora Imaging Technology (North Andover, Massachusetts) said that the Aurora 1.5 Tesla dedicated breast MRI system has received FDA clearance for AuroraSpectroscopy, the company's breast magnetic resonance (MR) spectroscopy package. The availability of AuroraSpectroscopy will provide Aurora Breast MRI the capability to perform in vivo breast MR spectroscopy (MRS) and MR spectroscopic imaging (MRSI). AuroraSpectroscopy was developed to supplement Aurora breast MRI by further improving the image specificity of this groundbreaking technology. The Aurora breast MRI remains the only FDA-cleared dedicated breast MRI system specifically designed for the detection, diagnosis and management of breast disease alone.

• CoolTouch (Roseville, California) has introduced the CoolLipo Trio, which allows physicians to perform laser-assisted lipolysis and skin tightening with CoolLipo, endovenous ablation with CTEV and non-ablative skin rejuvenation with CoolBreeze, all in one laser system. The CoolLipo Trio system is based on CoolTouch's signature 1320 nm wavelength, a wavelength that the company said has a proven track record for fat ablation, dermal collagen regeneration and endovenous ablation of varicose veins. The CoolLipo Trio's first and foremost modality is the CoolLipo procedure for laser-assisted lipolysis and skin tightening, which is used widely to sculpt small areas of the body such as the neck, jowls, chin, and saddlebags, or to tighten a loose belly. CoolLipo can be used in conjunction with larger liposuction cases by using the CoolBlue Duet, the only handpiece on the market that lases and aspirates simultaneously, reducing procedure time and providing tighter skin more efficiently.

• Nonin Medical (Minneapolis) has demonstrated the first Continua pre-certified pulse oximeter at the 5th annual Connected Health Symposium in Boston. Nonin said it collaborated with other companies in recent months to successfully complete the international connectivity standard for the interoperability of pulse oximeters, ISO/IEEE 11073-10404. "This is a significant step toward eliminating proprietary interfaces, allowing pulse oximetry equipment to communicate freely with other devices," said Kurt Kermes, standards architect at Nonin Medical.

• Roche Molecular Diagnostics (Pleasanton, California) said the FDA has approved the COBAS AmpliPrep/COBAS TaqMan HCV Test for use in the U.S. The test uses Roche's real-time PCR (polymerase chain reaction) technology to quantify the amount of hepatitis C RNA in a patient's blood. Physicians use hepatitis C viral load testing results to establish a baseline level of hepatitis C infection and to serially monitor viral load levels and treatment effectiveness in patients on therapy. The test is designed for use on the first fully automated, FDA-approved, real-time PCR platform, providing sample-in/results-out capability. The system menu includes an FDA-approved HIV viral load test, with continuous loading of samples in addition to parallel processing of HIV and HCV tests.

St. Jude Medical (St. Paul, Minnesota) reported the publication of a study on the St. Jude Medical Biocor stented tissue valve that found the valve provided excellent long-term durability as a replacement for the aortic valve in patients 65 and older. The study, which appears in the October issue of the Annals of Thoracic Surgery, evaluated the 20-year durability of the Biocor porcine valve in the aortic position. According to the study, over the 20-year follow-up period, the Biocor valve was found to perform well on key measures of long-term performance including freedom from reoperation due to structural valve deterioration (the rate at which patients remain free from another operation related to degeneration that could affect the valve's proper functioning).

Sanarus Medical (Pleasanton, California) said the American College of Surgeons Oncology Group, which just initiated a National Cancer Institute-funded Phase II clinical trial exploring the use of cryoablation therapy in the treatment of invasive breast carcinoma, has selected the Visica 2 treatment system from Sanarus as the exclusive technology to be used in the cryoablation portion of the study. The Sanarus Visica System has predominately been used in the cryoablation of non-cancerous tumors called fibroadenomas since its initial FDA market clearance in March 2002. This office-based procedure, which usually takes less than 20 minutes, involves placing a small needle into the center of the tumor using ultrasound guidance and subsequently freezing and killing the tumor. Sanarus said the safety and efficacy of cryoablation have been well established in more than 2,000 fibroadenomas that have been treated with the system to date.

• Sequenom (San Diego) reported the launch of an independent, prospective, multi-center observational study to document the performance of the company's SEQureDx Trisomy 21 technology for Down syndrome based upon Sequenom's SEQureDx technology. The study's primary goal is to document the performance (clinical sensitivity and false-positive rate) of Sequenom's T21 technology that uses fetal RNA in maternal plasma to identify Down syndrome in early pregnancy. The study has a secondary goal of developing a bank of samples to aid in improving SEQureDx T21 detectability in the identification of other chromosomal abnormalities.

Siemens Hearing Instruments (Piscataway, New Jersey) has introduced its Motion line of hearing instruments. Motion includes the Siemens feedback reduction algorithm, advanced localization, automatic learning, and speech and noise management system, so even in complex listening environments there is no need to change programs or adjust volume settings. Plus, it is available with optional Tek Bluetooth wireless enhancement with Tek connect remote control that streams music, phone calls, and TV audio to the hearing instruments in full stereo sound. Motion is available with algorithms such as SoundLearning and DataLearning that remember sound quality and volume settings, and eWindScreen that continually analyzes incoming signals to detect wind noise, then automatically adjusts signal processing to reduce it.

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