April 19, 2012 - St. Jude Medical Inc., a global medical device company, announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and the launch of the Trifecta aortic stented, pericardial tissue valve. The first procedures in Japan were performed at Osaka University Hospital and Saitama Medical University International Medical Center.

April 19, 2012 - The FDA received a report from a hospital that 16 patients had developed hospital-acquired infections with the bacteria Pseudomonas aeruginosa following an examination with transesophageal echo (TEE) ultrasound probes using Other-Sonic Generic Ultrasound Transmission Gel. Upon investigation, theultrasound gel was found to be contaminated with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca. Manufactured by Pharmaceutical Innovations Inc., the non-sterile gel is used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.

April 19, 2012 - Phoenix Cardiac Surgery, P.C., of Phoenix and Prescott, Ariz., has agreed to pay the U.S. Department of Health and Human Services (HHS) a $100,000 settlement and take corrective action to implement policies and procedures to safeguard the protected health information of its patients.

April 19, 2012 — Spherix Inc. announced results from its recently completed studies using near-infrared spectroscopy on autopsy samples from humans who had confirmed cardiovascular disease. Results showed that these atherosclerotic plaques had abnormally high amounts of macrophages and reduced levels of collagen and elastin. Reducing collagen and elastin weakens the plaques and contributes to plaque rupture, myocardial infarction and/or stroke.

April 17, 2012 — Isansys Lifecare Ltd., provider of complete real-time physiological patient data services and systems, announced that it has achieved CE certification for its LifeTouch Patient Surveillance System, comprising the LifeTouch HRV011 intelligent body-worn wireless sensor and associated Patient Gateway. The LifeTouch is the world’s first cloud-ready medical device of its kind.

April 17, 2012 — St. Jude Medical Inc. announced the first implant in its Accent MRI Pacemaker and Tendril MRI Lead IDE Study. The ultimate goal of the study is to determine if patients with these devices can safely undergo full-body, high-resolution magnetic resonance imaging (MRI) scans to better accommodate their medical needs.

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