News
Biosensors Receives CE Mark Approval for BioMatrix NeoFlex
May 20, 2013 10:54 am | by Biosensors International | CommentsBioMatrix NeoFlex features a new advanced stent delivery system, improving pushability, trackability, and crossability. It also has a lower lesion entry profile than its predecessor. BioMatrix NeoFlex retains the same combination of abluminal biodegradable polymer coating, proprietary limus drug Biolimus A9, and platform that has made the BioMatrix stent family an increasingly popular choice of DES in global markets where available.
EDAP's Ablatherm-HIFU Demonstrates Long Term Efficacy, Durability and Reproducibility With Prospective Fourteen -Year Study
May 20, 2013 10:46 am | by GlobeNewswire | CommentsEDAP TMS SA, the global leader in therapeutic ultrasound, announced today new long term data demonstrating high rates of both cancer-specific and overall survival of patients treated with high-intensity focused ultrasound. The study led by Drs. Sebastien Crouzet and Albert Gelet of Edouard Herriot Hospital, located in Lyon, France evaluated the morbidity and long term oncologic outcomes of primary HIFU therapy for localized prostate cancer.
CardioDx Announces Publication of the IMPACT-CARD Trial Demonstrating Use of Corus@ CAD Test Influenced Cardiologists' Clinical Management of Patients with Symptoms Suggestive of Obstructive Coronary Artery Disease
May 20, 2013 8:31 am | by The Associated Press | CommentsCardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced the publication of the IMPACT-CARD (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial in Critical Pathways in Cardiology. This prospective...
The Ohio State University Commences Key Comparative Study of Vycor's Patented ViewSite Brain Access System
May 20, 2013 8:30 am | by The Associated Press | CommentsVycor Medical, Inc. ("Vycor") (OTCQB: VYCO), a medical device company with a suite of FDA approved products, announced today that the Minimally Invasive Cranial Surgery Program at the Ohio State University (Columbus, OH) has commenced an animal study to evaluate a comparison of tissue damage...
Intermountain Healthcare Partners With Sotera@ Wireless
May 20, 2013 8:01 am | by The Associated Press | CommentsSotera Wireless@, creator of the ViSi Mobile@ wireless patient monitoring system, announced today that Intermountain Healthcare will officially partner with the Company. Furthering this collaboration, Intermountain Healthcare executive vice president and chief financial officer Bert Zimmerli ...
GE Scientists in Technology “Relay Race” Against Cancer
May 20, 2013 8:00 am | by The Associated Press | CommentsNISKAYUNA, N.Y.--(BUSINESS WIRE)--May 20, 2013--To commemorate National Cancer Research Month, a team of scientists from GE Global Research, the technology development arm of the General Electric Co. (NYSE: GE), are joined together in a technology “relay race” against cancer. They collectively are...
AB SCIEX Announces In Vitro Diagnostic Devices CE Marked for Europe
May 20, 2013 7:30 am | by The Associated Press | CommentsFRAMINGHAM, Mass.--(BUSINESS WIRE)--May 20, 2013--AB SCIEX, a global leader in analytical technologies, today announced the launch of the 3200MD CE-IVDD series for general in vitro diagnostic use in Europe. Meeting regulatory requirements to obtain the CE-IVDD mark for the new AB SCIEX API...
Medtronic Receives 'CE' Mark for 'Export Advance' Aspiration Catheter
May 20, 2013 7:06 am | by The Associated Press | CommentsExpanding its portfolio of medical technology for the interventional treatment of cardiovascular disease, Medtronic, Inc. (NYSE: MDT) announced today that the Export Advance aspiration catheter recently received the CE (Conformité Européenne) mark and will soon be launched in Europe and other international markets.
OrbusNeich's GenousT Stent Associated With Lower Restenosis Rate Compared to Bare Metal Stents in Low-Risk Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) Patients
May 20, 2013 5:00 am | by The Associated Press | CommentsOrbusNeich today announced that the company's Genous Stent is associated with a significantly lower rate of binary restenosis compared to bare metal stents (BMS) in low-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients at six months. Data from JACK-EPC, an...
Class I Medical Device Recall: Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters
May 20, 2013 12:00 am | by U.S. Food & Drug Administration | CommentsAt extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. For example, at a blood glucose value of...
Claret Medical, Inc. Announces Publication of the First Clinical Research on the Frequency and Composition of Embolic Debris Captured during TAVR
May 19, 2013 1:43 pm | by Bio-Medicine.Org | CommentsSANTA ROSA, Calif. , May 20, 2013 /- Claret Medical, Inc. announced the publication of an original manuscript by Dr. Nicolas Van Mieghem et al., Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement . Published ahead of print in Circulation, May 7 th this research is the result of a collaboration between Erasmus Medical Center, Rotterdam,
Stretta Procedure for GERD: Successful 10 Year Follow-Up Data Presented at Digestive Disease Week--Sustained Improvement, Long-Term Efficacy
May 19, 2013 8:24 am | by Bio-Medicine.Org | CommentsORLANDO, Fla. , May 19, 2013 /- The non-surgical Stretta® procedure employing low power and low temperature radiofrequency (RF) energy is effective in control of gastroesophageal reflux disease (GERD), and eliminates or reduces the need for medication 10 years post-procedure, according to an independent, prospective long-term assessment presented today at the Digestiv...
Statistical Challenges in Medical Device Trail Evaluation
May 17, 2013 4:30 pm | by The Associated Press | CommentsMedical devices are any medical items that are neither a drug nor a biological product. In light of their different mechanisms, actions and regulatory requirements, medical device (MD) trail evaluations are much more complicated than drug trails due to their unique clinical practices....
Wright Medical Hip Lawsuit Update: New Video Informs Patients Why Profemur Z Hip Implant Is Allegedly Failing
May 17, 2013 1:41 pm | by The Associated Press | CommentsSAN FRANCISCO--(BUSINESS WIRE)--May 17, 2013--Kent Klaudt, an injury lawyer at the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Lieff Cabraser released today a video on the injuries suffered by hip replacement patients who received the Profemur Z hip...
Blue Belt Technologies Announces Implant Co-Marketing Partnership with DJO Surgical
May 17, 2013 1:20 pm | by The Associated Press | CommentsPITTSBURGH--(BUSINESS WIRE)--May 17, 2013--Blue Belt Technologies, Inc., an innovative medical technology company commercializing robotic solutions for orthopedic surgery, announces an implant partnership with DJO Surgical, a DJO Global Company. Blue Belt’s NavioPFS orthopedic surgical system...
