The US Food and Drug Administration (FDA) has granted 510(k) approval to Surefire Medical's High-Flow Microcatheter. The Surefire Microcatheter, comprising of expandable tip, is designed to deliver therapy with higher infusion ...
Oculus Innovative Sciences has enrolled first patient, under an FDA-reviewed protocol, in a clinical study of its Microcyn hydrogel. Microcyn hydrogel is indicated for use in hypertrophic or keloid scars management. The double-blind, ...
Tags: Oculus Innovative Sciences, Microcyn hydrogel, keloid scars management
The Japan's Ministry of Health, Labour and Welfare has approved Thoratec's HeartMate II for use as a Bridge-to-Transplantation therapy for patients with advanced heart failure. The approval was based on a confirmatory clinical study, ...
Tags: Japan, health, therapy, heart failure
Epigenomics has reported positive results from a clinical study, which showed that its blood-based colorectal cancer (CRC) detection test is non-inferior in sensitivity when compared to fecal immunochemical testing (FIT). Using patients ...
Tags: Epigenomics, blood-based colorectal cancer, non-inferior in sensitivity
GI Dynamics has obtained conditional approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of its non-surgical EndoBarrier device. Flexible, tube-shaped EndoBarrier liner, which forms a physical ...
Tags: GI Dynamics, conditional approval, FDA, pivotal clinical trial
Guided Therapeutics has extended third consecutive year licensing agreement with Konica Minolta Technology Center to co-develop a non-invasive Barrett's Esophagus detection product. The Barrett's Esophagus product is based on the Guided ...
Tags: Guided, licensing agreement, Konica, co-develop
Idaho Technology, a provider of instruments for pathogen identification and DNA analysis, has initiated clinical trial of its FilmArray blood culture identification (BCID) panel. The FilmArray BCID panel, which will run on the company's ...
Tags: Idaho, BCID panel, pathogen detection system
Tokai Pharmaceuticals has gained FDA fast track designation for galeterone (TOK-001) for the potential treatment of metastatic castration-resistant prostate cancer (CRPC). Galeterone disrupts androgen receptor (AR) signaling, the key ...
Tags: galeterone, TOK-001, castration-resistant prostate cancer, CRPC
Cytori Therapeutics has expanded its Celution system's CE mark approval to include several new indications including cryptoglandular fistula. The Celution system, which pulls stem cells and other regenerative cells out of fat , provides ...
Tags: Cytori Therapeutics, cryptoglandular fistula, celution system
FDA has designated Stratatech's universal human skin substitute, StrataGraft, as an orphan drug for the treatment of partial and full thickness skin burns. As per the orphan drug status, the company will be able to market StrataGraft once ...
Health and Disability Ethics Committee of the New Zealand Ministry of Health has granted ethical approval for Living Cell Technologies' (LCT) Phase I Parkinson's disease trials of NTCELL. The company won regulatory authorisation to ...
Tags: ethical approval, Parkinson's disease trials, clinical study
Insmed has dosed first Cystic Fibrosis (CF) patient in the Clinical Evaluation of ARIKACE (CLEAR-108) phase 3 study of Arikace (liposomal amikacin for inhalation) in Europe. CLEAR-108 is a 300-patient randomized phase 3 trial comparing ...
Tags: Study of Arikace, pulmonary function, open-label safety study
Azelon Pharmaceuticals has completed a phase 2a trial comparing nasal spray ZT-034 to Forteo administered by subcutaneous injection and placebo in women with low bone mass. Patients in the phase 2 study, which saw the enrollment of 130 ...
The US Food and Drug Administration(FDA)has granted orphan drug designation to Savara Pharmaceuticals'first inhaled antibiotic,designed for the treatment of pulmonary methicillin-resistant Staphylococcus aureus(MRSA)infection in cystic ...
Tags: Orphan Drug, Savara Pharma, FDA, inhaled antibiotic, MRSA
Pulmatrix has announced the results of a clinical study showing that an iCALM (inhaled cationic airway lining modulator therapy) attenuated allergen-induced bronchitis in susceptible asthmatic patients. The study concluded that iCALM is a ...