U.S. breast surgeons will now have access to an intra-operative tissue assessment tool for early-stage breast cancer surgery. Dune Medical Devices (Boston) said it has received premarket approval from the FDA for its MarginProbe system. According to the company, the technology significantly improves surgeons' ability to intra-operatively identify cancer margins and reduce pathologically positive margins following a patient's initial lumpectomy surgery.

While the world did not end in 2012 as some imagined it would, based on a widespread misinterpretation of an ancient civilization's calendar, it was a year of great historical significance for medical technology. In many ways 2012 should be remembered as a turning point for the medical device industry, as several of the year's events are likely to impact medical innovation for decades to come.

It's that time of year when industry analysts dust off their crystal balls and make predictions, based on certain industry trends, for companies in their coverage universe in the coming year. This week Canaccord Genuity (Toronto) analyst William Plovanic named Insulet (Bedford, Massachusetts) a top growth stock for 2013 among the companies in his coverage universe.

Covidien (Mansfield, Massachusetts) reported the five-year results of its ClosureFast long-term European multi-center study in patients with chronic venous insufficiency (CVI). This study evaluates the five-year outcomes of a minimally invasive endovascular therapy for treatment of CVI. The ClosureFast study was conducted prospectively at eight centers in Europe.

St. Jude Medical (St. Paul, Minnesota) reported the first patient enrollment in its ILUMIEN I clinical study. This observational study is designed to show the optimal way optical coherence tomography (OCT), an intravascular imaging technology, combined with the St. Jude PressureWire Aeris, a wireless interventional tool designed to measure fractional flow reserve (FFR), can guide stent implementation in patients with coronary artery disease.

The first patient has been implanted with the Boston Scientific next generation Ingevity pacing leads in a clinical trial designed to establish the safety, performance and effectiveness of the leads, the company reported.

Maquet Cardiovascular (Wayne, New Jersey), a provider of intra-aortic balloon (IAB) therapy devices, reported this week that the Circulatory System Devices Panel of the FDA recently voted to support the agency's reclassification of intra-aortic balloon pump (IABP) devices for certain indications to Class II (general controls and special controls) from Class III (general controls and pre-market approval). Those indications that received a recommendation to be reclassified to a Class II designation include acute coronary syndrome, complications of heart failure of both ischemic and non-ischemic etiologies, and cardiac and non-cardiac surgery.

When I signed up for my first half-marathon, which took place recently on the Las Vegas strip at night, I knew I was in for a tremendous challenge. But I had no idea I would be finishing the 13.1 mile race while battling a small bowel obstruction. While this setback easily could have sidelined me from the race, it made me all the more determined to see it through. The...