St. Jude Medical (St. Paul, Minnesota), reported the launch of its MediGuide Technology, a three-dimensional (3-D) navigation system intended for the evaluation of vascular and cardiac anatomy on a recorded fluoroscopic image instead of live fluoroscopy (a series of X-ray images).
ATLANTA — Device and pharma companies have long griped about issues with the FDA. It seems to be a mantra that runs through the industry. A panel held at the 2012 Georgia Life Sciences Summit on Wednesday spent a bit of time preparing companies for some of the issues that it might encounter along path to regulatory approval, and issues that could occur after commercialization.
MindChild Medical (North Andover, Massachusetts), a med-tech company that was founded in 2008, reported that it has received clearance for its Meridian non-invasive fetal heart monitor. The company said that additional pre-market regulatory filings are anticipated during 2012 and 2013.
An emerging medical device company has developed what it calls a new paradigm in femorpopliteal nitinol stents. IDEV (Webster, Texas), a firm that has remained relatively quiet about it's progress in the past, has opened up to Medical Device Daily to talk to about its Supera stent and the SUPERB trial evaluating the device.
It is widely known that breast cancer is the second most common cancer among women in the U.S. However, many patients and physicians are unaware that the process of collecting and evaluating the biopsy specimens used to render these cancer diagnoses involves nearly 20 steps and several medical professionals working in different locations.