Inspired Technologies (North Huntindon, Pennsylvania) said it has obtained FDA approval for its VIAspireLiquefier. The VIAspire makes liquid oxygen in the home for patients requiring oxygen therapy, such as those with chronic obstructive pulmonary disease (COPD). The VIAspire maintains two liters of liquid oxygen that are always available to the patient. Compatible with the VIAspire are oxygen portables in three different sizes, allowing patients to maintain active lifestyles. These portables, with proprietary SmartDose technology, are the first devices to sense and adapt to the patient’s respiratory needs, especially during exercise, a key to improving patient outcomes. Inspired Technologies is a respiratory device company.

• Sequenom (San Diego) reported that research conducted under the cancer program at the Australian-based Garvan Institute of Medical Research demonstrated the successful utilization of Sequenom’s MassARRAY EpiTYPER technology for providing detailed DNA methylation analysis critical for comprehensive profiling of normal and disease DNA methylation patterns. DNA methylation is important for the functional analysis and characterization of gene targets and is widely recognized as key to understanding, and potentially treating, various forms of cancer. Sequenom makes fine mapping genotyping, methylation and gene expression analysis solutions.

• Siemens Medical Solutions Diagnostics (SMS Diagnostics; Tarrytown, New York) reported the launch of the DCA vantage analyzer, a point-of-care (POC) diabetes patient management platform providing glycosylated hemoglobin (HbA1c), microalbumin/creatinine and albumin-to-creatinine tests for diabetes management. The DCA vantage analyzer is critical for monitoring a patient’s glycemic control and helps physicians to encourage patient compliance by delivering actionable test results during a patient visit. The system delivers the simplicity and convenience required at the point of care with no sample or reagent preparation steps. The product is pending FDA clearance and is not yet available for in vitro diagnostic use in the US. SMS Diagnostics specializes in diagnostic solutions that assist in the diagnosis, monitoring and management of disease.

• Small Bone Innovations (SBI; New York) said that its Artelon STT spacer has been cleared by the FDA for marketing in the U.S. The spacer is implanted in the scapho-trapezio-trapezoidial (STT) joint between the scaphoid and trapezial-trapezioid bones near the base of the thumb. The spacer is similar in size to the Artelon CMC Spacer LG, except that it has a ‘single-wing’ design (an L-shape vs. a T-shape), of woven, degradable Artelon fibers. The spacer is designed to preserve the STT joint and to help restore joint function while minimizing the need to sacrifice healthy bone and tissue. SBI makes products, technology and education for the small bone and joint sector of the orthopedic industry.

• The Sorin Group (Denver, Colorado) reported that it has received FDA approval for its MEMO 3D semirigid annuloplasty ring. Annuloplasty rings are indicated for repair of the mitral valve and are designed to remodel the anatomical shape of the mitral annulus, preventing further dilatation and minimizing the risk of late repair failures. The annuloplasty ring has already been introduced in several European countries. Sorin Group is a cardiovascular company.

• Verax Biomedical (Worcester, Massachusetts) reported FDA clearance for its platelet PGD test system. The company said that the system cuts the detection time for bacterial contamination in leukocyte reduced apheresis platelets to about 30 minutes. To combat the risk of bacterial contamination, the American Association of Blood Banks (AABB), requires all of its members to detect and limit contamination in platelets. Recent articles published in Transfusion, the journal of the AABB, indicate that current culture testing methods fail to detect half of the contaminated units in the U.S. inventory and false negative results associated with this testing have resulted in 26 documented septic transfusion reactions including five fatalities since testing began in 2004. The platelet PGD test is designed to allow testing after platelets have entered the inventory and offers clinicians the opportunity to detect contaminated units that slip past current testing methodologies. Verax Biomedical makes rapid tests for detecting bacterial contaminants in blood cells and tissue.

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