There isn’t much that stays behind closed doors these days, and the case of Jim Mazzo, the outgoing CEO of Advanced Medical Optics, might be nothing more than a case of camaraderie-loosened lips … or something more toxic. To recap, Mazzo, has been charged by the SEC with insider trading violations thanks to trades made by several former professional baseball players. The thread of the story seems to be that Mazzo told Doug DeCinces in 2008 of the then-impending move by Abbott to acquire AMO. It appears DeCinces then relayed the scoop to a couple of other former major league...

Sooner or later, we’ll all know someone who has lost his or her life to heart disease, and today, Sept. 10, 2012, is the 20th anniversary of my father’s passing. George Edward McCarty had undergone a triple bypass several years earlier, but restenosis of the coronary arteries and an otherwise failing heart would be his undoing. The world of medical technology has changed enormously since Dad died, so much so that what we now take for granted might have seemed miraculous in 1992. Would Dad have lived another 20 years had his predicament arisen 20 years later in medical history?...

The world of cardiology still holds a spot front and center in the realm of medical technology, so it only seems fitting to celebrate the birth of Michael Ellis DeBakey, MD, whose birth on Sept. 7, 1908 was followed by his passing very nearly 100 years later to the day, July 11, 2008. In the ten decades between those two dates, the physician was published more than a thousand times in medical journals and in bound books. DeBakey’s name would become synonymous with pioneering efforts in circulatory system surgery, but the man who was born Michael Dabaghi in Lake Charles,...

Jeff Shuren, MD, has brought a lot of changes to FDA’s Center for Devices and Radiological Health, but there are those who think Shuren has not gone far enough while others think he’s gone too far. None of this would matter so much but for the potential for a GOP take-over of the White House. It’s no secret that Shuren’s administration of CDRH has not lacked for controversy, but what some might not realize is the enormous pressure Shuren is under. So what you say? There are several members of Congress who are quite critical of CDRH, but maybe none...

Sometimes news comes in bunches. That’s not typically the case in the month of August, which is ordinarily a pretty quiet month. Not this year, though. Here are three stories that stick out, in one case like a sore thumb. Post-market studies for ICD leads FDA announced it will require section 522 studies for a range of ICD leads made by St. Jude Medical. This is not the first time the new FDA has required 522 studies for groups of devices as the 522 orders for surgical meshes, hip implants, and dynamic spinal stabilization systems suggest. I might add that...

Having grown up in a small rural town in South Carolina, I can attest to the fact that sometimes your choices for service are usually few and far between. Typically, there's only one of anything, and if you want to check out a competitor be prepared to drive at least 50 miles out. This is the case especially when it comes down to healthcare needs. One of my family members is now in a position where she sees a specialist who is about 60 miles away. Every Tuesday she dreads that long commute, which is reflected through her blood pressure...

A few years ago Brad Paisley released “Welcome to the Future”, a song about all the changes he has seen in his lifetime and how some of the capabilities we have at our fingertips now, in terms of information technology, was merely a dream not that long ago. Paisley’s song has always struck a chord with me, pardon the pun, because our world is so fast-paced we don’t often pause long enough to think about the progress we have made. The same could be said for the medical device industry. A lot of devices that are in doctors’ hands today,...

It's not always doom and gloom in the med-tech industry. Some med-tech companies are making significant strides, and it doesn't always revolve around garnering a significant funding or getting FDA approval on a product. Nearly two months ago, Instrumentation Laboratory (Bedford, Massachusetts) took a bold leap with its Hemostasis product line in North America, and decided to go with a new direct sales, support and service model. Previously the company had a strategic alliance cross-distribution agreement with Beckman Coulter (Brea, California) for about 20 years, which it deemed successful. The company already has a direct customer model in its critical...

Oscar Pistorius didn’t win a medal in the just-concluded Olympic Games. Not a gold, not a silver, not a bronze. In fact, he finished last in his semifinal heat of the 400-meter run (I think they call it the 400-meter dash, although I can’t fathom any race that requires one full lap around the track being called a dash), and his South African relay team finished next-to-last in the finals of that event. But the 25-year-old Pistorius leaves quite a legacy behind in London, and not just because he became the first double-amputee athlete to compete against normal, able-bodied athletes...

By Steve Deaton MDD Perspectives Contributing Writer Editor’s note: Steve Deaton is the vice president of sales at Viztek, a provider of complete digital software and hardware imaging solutions for the med-tech industry. In healthcare there is an evolving trend of making data accessible and easily sharable, and this change is being enabled through cloud-based infrastructure.. The cloud eliminates the need for on-site server space and maintenance through virtual servers that are both secure and flexible. A broad shift to cloud services in healthcare will have multiple implications for both physicians and their patients. The Cloud Brings Changes for Patients...