Sunshine Heart has obtained a conditional approval from the US Food and Drug Administration (FDA) for its investigational device exemption (IDE)) implantable heart assist device. The non-blood contacting C-Pulse Heart Assist device, ...
Tags: C-Pulse IDE Device, FDA, clinical trial
The US Food and Drug Administration (FDA) has granted 510(k) clearance to NeuroMetrix's Sensus pain management system, designed as a treatment for painful diabetic neuropathy. The Sensus system is designed for use as a non-invasive ...
Sunshine Heart has submitted an investigational device exemption (IDE) application of its C-Pulse Heart Assist system to the US Food and Drug Administration (FDA) for approval. The basis of the IDE application is for the initiation of ...
Tags: FDA, medical system, medical technology
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Nanosphere's CYP2C19 nucleic acid test to determine gene variants affecting drug metabolism. The CYP2C19 enzyme, in general, metabolizes approximately 15% of all ...
Tags: FDA, CYP2C19 enzyme, automated sample-to-result Verigene system
Micronics has introduced a new portable in vitro agglutination test to determine patients' individual blood type and Rh factor from a fingerstick of blood. The ABORhCard is a qualitative disposable blood typing device which eliminates the ...
Tags: Micronics, blood typing device, ABORhCard, agglutination test, FDA
SRS Medical, a provider of urology products, has purchased AbbeyMoor Medical's Spanner temporary prostatic stent. SRS Medical CEO Lee Brody said the Spanner is a synergistic addition to the company's suite of urology products for the ...
Tags: acquisition, urology product, clinical trial
Given Imaging has purchased SmartPill's wireless GI monitoring system, designed for evaluating motility disorders such as gastroparesis and constipation, for $6m. The FDA-approved and CE-marked non-imaging capsule system, which ...
Tags: acquisition, wireless GI monitoring system, medical application
Surefire Medical, a developer of infusion systems, has received CE mark approval for its new Surefire infusion system, designed for use in chemo and radioembolization procedures. The CE mark approval is based on a recent retrospective ...
Tags: CE mark, infusion system, Surefire
Sunshine Heart is planning to initiate a US pivotal trial on its C-Pulse Heart Assist device in the fourth quarter of 2012, as it received an unconditional approval from the US Food Drug Administration (FDA). The CE marked system, ...
Tags: FDA, clinical trial, medical system
GenMark Diagnostics has obtained the US Food and Drug Administration's (FDA) 510(k) clearance for its eSensor Respiratory Virus Panel, designed for use on its XT-8 system. The test is intended to simultaneously detect and differentiate 14 ...
Tags: GenMark, FDA clearance, eSensor Respiratory Virus Panel, XT-8 system
GE Healthcare has purchased U-Systems, a manufacturer of ultrasound products for breast applications. As part of the deal, GE Healthcare will acquire U-Systems' somo v Automated Breast Ultrasound (ABUS) system, designed for screening ...
Tags: GE Healthcare, purchase, U-Systems, ABUS system, clinical study
The US Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics' BioFlo peripherally inserted central catheters (PICCs) with a permanent and non-eluting integral polymer Endexo technology. The BioFlo PICCs is ...
Tags: FDA, clearance, PICCs, BioFlo PICCs, PASV Valve technology
OneSource Medical Group in Florida has entered into an agreement to distribute NeuroMetrix's transcutaneous electrical nerve stimulator, designed to help manage chronic pain in diabetes patients with painful diabetic neuropathy. The ...
Tags: OneSource, agreement, NeuroMetrix
Philosys is looking forward for the US Food and Drug Administration (FDA) approval of its new Gmate blood glucose monitoring system in third quarter 2012. By utilizing Smartphone technology, Gmate blood glucose meter works with the ...
Tags: Philosys, FDA approval, blood glucose monitoring system
The AtriCure has obtained the US Food and Drug Administration (FDA) clearance to commence three-year Ablate post approval study (PAS), designed for the surgical correction of atrial fibrillation. The 350 patient study is designed to ...
Tags: AtriCure, FDA clearance, post approval study, PAS, Synergy ablation system