Alere Inc received confirmation that the US Food and Drug Administration (FDA) has cleared the Techlab® Shiga Toxin Quik Chek test for the US market. Shiga Toxin Quik Chek is the only rapid diagnostic available that can detect Shiga ...
Tags: Alere Inc, Techlab, Shiga Toxin Quik Chek, E.coli
The US Food and Drug Administration(FDA)has granted 510(k)clearance to Ascendx Spine's minimally invasive Ascendx VCF Repair system,designed for the treatment of vertebral compression fractures(VCFs). The VCF Repair system,unlike the ...
Antares Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Otrexup, a combination product to deliver methotrexate methotrexate (MTX) using Medi-Jet technology. Antares Pharma president ...
Tags: NDA, FDA, medical technology
Insulet has gained the US Food and Drug Administration's (FDA) 510(k) approval for its new version of tubeless insulin pump. The new easy-to-use OmniPod insulin management system features the same 200-unit insulin reservoir capacity, ...
Tags: FDA, Insulet, tubeless insulin pump, clinical technology
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's non-instrumented molecular diagnostic assay, designed for the detection of toxigenic Clostridium difficile (C difficile) bacterial DNA. The AmpliVue C. ...
Tags: FDA, Non-Instrumented C Difficile Detection Assay, medical technology
Abbott has received US Food and Drug Administration clearance for its new testosterone test, ARCHITECT 2nd generation testosterone assay. The testosterone assay is expected to help physicians to accurately measure the wide range of ...
Tags: FDA, testosterone test, clinical technology
Matrix Surgical has obtained CE mark and ISO 13485:2003 certification for its OMNIPORE High-density Porous Polyethylene craniofacial implants. The craniofacial implants, which are manufactured in the US, are designed for use in ...
Tags: CE Mark, ISO Certification, Surgical OMNIPORE Craniofacial Implants
Atherotech Diagnostics Lab, a CLIA-certified clinical reference laboratory, has entered into an agreement to offer BG Medicine's galectin-3 testing services to laboratory customers and physicians. To offer the services, Atherotech is ...
US-based True Taste is recalling seafood products as they may have the potential to be contaminated with Clostridium botulinum,a bacterium which can cause life-threatening illness or death. The products being recalled are vacuum packaged ...
Tags: seafood products, True Taste, Hot Smoked Products, Clostridium botulinum
Syneron Medical has received the US Food and Drug Administration (FDA) approval for its new elos Plus multi-platform device. The new elos Plus device utilizes the company's proprietary elos technology of optical energy and bi-polar ...
Tags: FDA, elos Plus multi-platform device, medical technology
Sorin Group has purchased a manufacturer of cannulae and catheters, California Medical Laboratories, for $14m. The acquisition will strengthen Sorin's existing cannulae product line as well as complement the recent acquisition of the ...
The US Food and Drug Administration (FDA) has cleared Dexcom's new continuous glucose monitoring (CGM) system. The G4 PLATINUM system comprises a tiny sensor which is inserted by the user under the skin on the abdomen and a transmitter ...
Tags: Dexcom, continuous glucose monitoring system, G4 PLATINUM system
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex Incorporated's new line of Weck reusable obturators, designed for use during laparoscopic procedures. The stainless steel obturators, which are ...
Tags: FDA, laparoscopic procedure, medical tool, medical technology
The US Food and Drug Administration (FDA) has cleared Respiratory Motion's ExSpiron respiratory monitoring system, designed for monitoring breathing abnormalities often associated with potentially lethal respiratory depression. ...
Tags: FDA, respiratory monitoring system, clinical technology
US medical center, Mayo Clinic, has signed a pre-clinical research agreement with MagForce. Under the agreement, Mayo Clinic will begin a research program to investigate the preclinical efficacy of the MagForce's NanoTherm therapy in ...