• Lantheus Medical Imaging (N. Billerica, Massachusetts) reported the initiation of a Phase 1 clinical study to assess the safety, dosimetry and tolerability of LMI1195, a novel F-18 small molecule tracer for imaging cardiac neuronal function, in healthy subjects, undergoing positron emission tomography PET imaging. The Phase 1 open-label, non-randomized, single-dose study will be conducted in the U.S. The study is designed to estimate the radiation dosimetry of LMI1195 in healthy subjects undergoing a PET scan. The study will also evaluate the safety and tolerability of the tracer, gather pharmacokinetic and metabolic data, and assess PET imaging parameters and image quality, Lantheus said.

• Medifocus (Vancouver, British Columbia) said it has filed a "comprehensive response" to its IDE application with the FDA to obtain clearance to initiate a pivotal phase III clinical trial using its Microfocus APA 1000 system for the treatment of breast cancer. The company said this response was the result of a letter it received from the FDA in July requesting clarification, recommendations and additional information from Medifocus. The company said the pivotal clinical trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, of using focused microwave heat energy delivered by the Microfocus APA 1000 system in combination with neo-adjuvant chemotherapy on large breast cancer tumors. A total of 238 patients will be entered into the study.

• Medtronic (Minneapolis) reported that a process improvement program significantly improved the quality of care on six of seven guideline-recommended care measures in the largest U.S. outpatient heart failure clinical study. Twenty-four month findings from IMPROVE HF, funded by Medtronic, demonstrated that clinics using the process improvement program increased adherence to evidence-based, guideline-recommended care by 82% and 62%, respectively, for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) use, and 80% for aldosterone antagonist use, all relative to baseline results. Use of angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (ARB), beta blockers and heart failure education also showed significant improvement. Medtronic also reported results released today from the FAST clinical trial. Results showed that Medtronic OptiVol Fluid Status Monitoring, which measures changes in fluid build up in the chest cavity, predicted 76% of future heart failure events as compared to only 23% detected by weight monitoring alone. OptiVol uses low-level electrical pulses that travel across the thoracic cavity (the chest area encompassing the lungs and heart) to measure the level of resistance, indicating fluid in the chest – a common sign of heart failure. Since normal fluid levels vary from patient to patient, and fluid accumulation can be either slow or rapid, OptiVol's ability to measure fluid status trends over time can provide important insights that are used in conjunction with ongoing monitoring of other patient signs and symptoms.

• Meridian Bioscience (Cincinnati) said it has been granted a special 510(k) clearance to update the TRU FLU package insert to include analytical sensitivity claims with two strains of 2009 H1N1 virus cultured from positive respiratory specimens. TRU FLU is a rapid test designed to identify influenza A and B in human specimens, the company said. According to Meridian, its TRU FLU and TRU RSV products are unique in that they feature a closed test system that allows a specimen to be contained within the device once it has been inserted. While the performance characteristics of the device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established, the analytical sensitivity claims with the two strains adds an additional important product benefit, Meridian noted.

• Quidel (San Diego) said it has received special 510(k) clearance for an update to its QuickVue Influenza A+B test package insert to include reactivity with culture isolates of the 2009 H1N1 Influenza A virus. Although the QuickVue Influenza A+B test has been shown to detect the 2009 influenza A (H1N1) virus, the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1) virus have not been established, Quidel said. The test kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes. This clearance supplements the reactivity with 13 other isolates of seasonal H1N1 influenza viruses currently listed in the package insert.