We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Abbott is reminding users of its FreeStyle and FreeStyle Flash blood glucose meters in the United States to check to make sure their meter is displaying the correct unit of measure (milligrams per deciliter, mg/dL) and strip calibration code each time they test.
AtriCure, Inc., a medical device company focused on developing, manufacturing and selling innovative surgical devices, announced that it has received Food and Drug Administration (FDA) 510(k) clearance for its Isolator Transpolar Pen System (Pen) for pacing, sensing, stimulating, and recording during the evaluation
of cardiac arrhythmias in addition to its currently FDA- cleared use for the ablation of cardiac tissues.
Roche Diagnostics announced that a district judge in New York has ruled in favor of Roche Diagnostics on important aspects of patent infringement allegations brought by Enzo Biochem.
Although the American Association for Clinical Chemistry (AACC) supports a recent FDA guidance on informed consent for in vitro diagnostic device clinical trials, the group says several guidance details remain unclear.
A study published in the July 2006 edition of Journal of Urology has shown that UroVysio, a DNA-based urine test that detects important genetic changes in bladder cells, has almost twice the sensitivity of conventional urine cytology tests, the current gold standard, as an aid for the initial diagnosis of bladder cancer in patients with hematuria (blood in urine) suspected of having bladder cancer.
Wednesday, Cardica, Inc., an automated anastomotic system maker, revealed the approval of its C-Port xA Distal Anastomosis System with the grant of the European CE Mark or Conformite Europeenne.
Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, has submitted a Premarket Notification (510k) to the U.S. Food and Drug Administration (FDA) for the Company's AspirinWorks Test Kit, the Company's newest diagnostic product for cardiovascular disease.
A St. Paul startup company is bulking up to take on Medtronic Inc. and others in what is becoming one of the hottest areas in the medical industry treatments for obesity.