Jubilant Draximage (JDI) and Positron have entered an agreement to sourceand supply Strontium-82 and Rubidium-82 generators. The collaboration is expected to facilitate the stabilization, security and growth of the industry by increasing ...
Tags: cardiac PET scanners, Strontium-82, Rubidium-82 generators
Inhaled nitric oxide drug products developer GeNO has received four additional US patents on its proprietary inhaled nitric oxide (NO) generation chemistry and delivery technology, bringing the total number of US patents to sixteen. The ...
Tags: inhaled nitric oxide drug, NO, NO2, GeNO
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 ...
Quest Diagnostics has received FDA 510(k) clearance for its Simplexa C difficile Universal Direct Test on the 3M Integrated Cycler. The test, which uses a proprietary chemistry that eliminates the need for nucleic-acid extraction, is ...
Tags: Quest Diagnostics, 3M integrated cycler, Simplexa tests
MicroPhage has gained an additional FDA 510 clearance for its KeyPath MRSA/MSSA Blood Culture Test-BT. Blood test was initially cleared to diagnose and distinguish methicillin resistant and methicillin sensitive Staphylococcus aureus ...
Tags: MicroPhage, KeyPath platform, MRSA/MSSA Blood Culture Test-BT
BG Medicine has filed 510(k) premarket notification for regulatory clearance of an expanded indication for its BGM Galectin-3 test with the FDA. The blood test is at present indicated for use in patients with chronic heart failure who are ...
Tags: BG Medicine, blood test, heart failure
The US Food and Drug Administration (FDA) has granted 510(k) clearances to Hollywog's new WiTouch and WiTouch Pro wireless remote controlled devices. The WiTouch devices, which incorporates TENS technology, are designed for the ...
Tags: FDA, treatment of back pain, wireless remote controlled device
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Semprus BioSciences' vascular access catheter, designed to provide peripheral access to the central venous system. Using Semprus Sustain technology, the ...
Soligenix has received FDA clearance for SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) investigational new drug (IND) application for the induction treatment of pediatric Crohn's disease. With the IND clearance, ...
Quidel has received FDA 510(k) clearance for its Quidel Molecular Influenza A+B assay for the detection of influenza A and B for use with Cepheid's SmartCycler PCR system. Quidel received FDA clearance in December 2011 to run its Quidel ...
Tags: Quidel, FDA 510(k)clearance, Quidel Molecular Influenza A+B assay
GenMark Diagnostics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its eSensor Respiratory Virus Panel(RVP) for use on its XT-8 system. The eSensorRVP test simultaneously detects and differentiates 14 ...
Tags: XT-8 system, FDA, clinical technology, clinical research
Meridian Bioscience has received FDA clearance for TRU Legionella, a new rapid assay for detection of legionellosis. TRU Legionella provides optimized detection of Legionella pneumophila serogroup 1 that is most commonly associated ...
Tags: TRU Legionella, detection of legionellosis, clinical research
GI medical devices developer Given Imaging has submitted an application to US Food and Drug Administration(FDA)seeking approval to use its non-invasive imaging tool for visualization of the lower gastrointestinal tract. The PillCam Colon ...
Tags: PillCam Colon 2 capsule endoscopy system, Given Imaging
The US Food and Drug Administration (FDA) has cleared X-spine's new spinal systems to treat various spinal pathologies. The products including Fortex CoCr Rod system incorporates a new cobalt chromium fixation rod, designed to provide ...
Tags: FDA, spinal systems, Fortex CoCr Rod system
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Providence Medical Technology for its PMT Bone Screws, designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture ...
Tags: FDA, PMT Bone Screws, disposable instruments, disposable implants