• Covidien (St. Louis) said the FDA has granted tentative approval for the company’s abbreviated new drug application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien’s tentatively approved product is a generic of Cardiolite, which is a myocardial perfusion imaging agent used for detecting coronary artery disease.
• Drawing on its experience in disease management for Medicaid patients and success with consumer-based technologies, McKesson (Alpharetta, Georgia) reported the introduction of its Community Care Advantage offering. The company said Community Care Advantage supports hospitals and other provider-based organizations in their efforts to become more effective care managers for their community populations and “helps providers to drive a higher quality of care while mitigating their financial risk.” These solutions support community wellness and chronic disease programs that extend to the special needs of indigent patients and all patients who have recently been discharged from the hospital. McKesson is a healthcare services and information technology company.
• MEDecision (Wayne, Pennsylvania) reported the general availability of Alineo clinical programs for its recently released Alineo collaborative healthcare management platform. Alineo clinical programs is comprised of clinical care pathways that help payers formulate appropriate plans of care for more than 30 different conditions, including asthma, congestive heart failure, coronary artery disease and diabetes. The pathways present the optimal treatment procedures for each disease based on the most recent medical literature, best consensus statements from expert societies and the documented opinions of experts in relevant medical fields. Alineo uses national standards from leading independent authorities, including the American Diabetes Association, American College of Cardiology/American Heart Association, and the National Heart, Lung and Blood Institute as guidelines for generating questionnaires that care managers can use to collect information during member interactions. Alieno provides collaborative healthcare management solutions.
• Millipore (Billerica, Massachusetts) reported another product as part of its Stem Cell-Tested initiative, the Millicell 1 m 24-well filter plate. Many of Millipore’s filter products will be validated for use on stem cells. Millipore’s Stericup with Millipore Express Plus membrane was the first product available under this initiative. This Millicell plate is the second product available under the initiative. Millicell filter plates are optimized to support suspension and adherent cell growth and differentiation. The 24-well plate is designed for maximum user convenience and includes features that maintain assay integrity. Millipore makes technologies, tools and services for the bioscience research and biopharmaceutical manufacturing industry.
• Nutra Pharma (Boca Raton, Florida) said that its wholly owned medical devices subsidiary, Designer Diagnostics, has started marketing what it said is the first-ever environmental test kit for the detection of nontuberculous mycobacteria (NTM) in water and soil. NTM, also known as atypical tuberculosis (Atypical TB) or mycobacterium other than tuberculosis (MOTT), is a bacteria that is found in a multitude of environments - in the soil, in some domestic and wild animals, and perhaps most importantly, in water, including showers and hot tubs. One of the most common forms of NTM infections found in humans is Mycobacterium avium complex. Nutra Pharma is a biotechnology company that is developing drugs for HIV and multiple sclerosis.
• OtisMed (Hayward, California) reported the launch of a patient registry designed to gather clinical and economic outcomes data on OtisKnee, a new total knee replacement technology that allows surgeons to customize the size and placement of the knee implant to each individual patient’s anatomy. Called COMFORT (Comprehensive Outcomes Measures for OtisKnee Replacement Technique), the registry is expected to include thousands of patients at hundreds of hospitals across the U.S. Data gathered in the COMFORT registry will be used to evaluate a variety of measures, including post-operative pain, range of motion, patient satisfaction and recovery rate as well as surgical time, operating room set-up time and cost, and hospital length of stay. OtisMed is a orthopedic technology company.
• QuantRx Biomedical (Doylestown, Pennsylvania) said that David Elmaleh, chairman and chief scientific founder of FluoroPharma, will present findings from the company’s Phase I trial for CardioPET, a metabolic cardiac imaging agent for the assessment of coronary artery disease. The trial was a single-center, open-label study, designed to evaluate safety, dosimetry, and pharmacokinetics of CardioPET as a PET tracer for myocardial imaging. Fifteen normal healthy volunteers and six CAD patients participated in the Phase I trial. FluoroPharma is a molecular imaging company engaged in the discovery and development of products for the PET market. QuantRx Biomedical is a diagnostics company that makes products based on its technology platforms.