I went to see my doctor a few weeks ago for a physical. Since I just turned 40, he recommended that I have a CT scan to check for calcification in my heart valves. Maybe I would have said "no," when he mentioned that the cost would not be covered by insurance, but his cautionary tale about a person he knew who had collapsed and died of a heart attack at the age of 42 persuaded me that maybe this was a good idea after all. I went in for the test yesterday and the entire procedure took less than...
Back in the early days of Medical Device Daily – in fact, it might even have been in the relatively brief very early period of time when the new publication was known as Medical Device Week – it’s likely that few if any healthcare-related companies got more frequent mention in our pages than MedCath. Thinking back on that time, it seems like news stories on the high-flying operator of heart-focused specialty hospitals were appearing in MDW and then MDD with amazing regularity. It was “MedCath reported this week plans to open a new hospital in . . .” or “MedCath...
Medtronic (Minneapolis) reported that it is funding two independent reviews of studies of its Infuse bone graft in the wake of criticism of the clinical trials it conducted to support the device. (Medical Device Daily)
When one thinks about countries that are hotbeds for medical technology innovation, Israel would not likely be at the top of anyone’s list. But people in the know will tell you that this small country, with a population of just a shade over 7.5 million people, has a reputation for being a tireless innovator in the field, with countries from all over the world flocking there to study their business model. According to the Israeli Life Science Industry, an advocacy group, the med-tech industry is also young and growing. Of the currently operating 702 companies, 56% were founded during the...
President Barack Obama unveiled his deficit reduction plan last week, calling for a mix of spending reductions and tax hikes that the White House claims would cut federal deficits by $4 trillion over the next 12 years without gutting popular programs such as Medicare and Medicaid, a challenge that may be difficult to achieve given the level of debt in the U.S. Obama's plan calls for a repeal of the Bush-era tax cuts on families making more than $250,000 annually. The president also called for the creation of a "debt fail-safe" trigger that would impose automatic across-the-board spending cuts and...
It’s easy to understand the excitement about the PARTNER trial, sponsored by Edwards Lifesciences (Irvine, California), the company that makes the much talked about transcatheter aortic valve replacement (TAVR) device, called the Sapien. After all, given the choice between open heart surgery or a non-surgical alternative most patients would prefer the latter. However, the data from the study, which was presented earlier this week at the American College of Cardiology (Washington) annual meeting in New Orleans, showed that TAVR patients were also more likely to have a stroke following the procedure. In the study, major strokes were higher for TAVR...
Late last month, Medtronic (Minneapolis) reported that it was cancelling several of its largest contracts with group purchasing organizations (GPOs) worth more than $2 billion collectively. Medtronic said the decision to cancel five contracts with Novation (Irving, Texas) and another with Premier (Charlotte, North Carolina) will save it about $60 million a year. Wall Street reacted positively to the news and some industry watchers are wondering if other companies will follow suit and bypass GPOs to sell products directly to hospitals. GPOs – which use high volume purchasing power to secure discounts for hospitals, introduce new devices to the market,...
The recess appointment of Donald Berwick, MD, to the administrator’s position at the Centers for Medicare & Medicaid Services (CMS) last July roiled many members of Congress, and a recent Senate letter to the Obama administration expressing disfavor for Berwick’s continued presence at CMS may have finally lain to rest any chance that he had of a successful confirmation hearing. The letter, whose principal authors include Sen. Mike Enzi (R-Wyoming), the ranking GOP member of the Senate Health, Education, Labor and Pensions Committee, and Orrin Hatch (R-Utah), the ranking GOP member of the Senate Finance Committee, cite Berwick’s “past record...
Patent reform legislation has been in the news quite a bit the past few weeks in the U.S., with both chambers of Congress working on legislation that could affect the way patents are currently registered. The U.S. patent system is currently based on a first-to-invent doctrine, which means that the inventor who first conceived of the invention and then reduced it to practice by filing a patent application is considered the first inventor and is entitled to patent protection. Every other country in the world, except the Phillipines, has a patent system based on the first-to-file doctrine, in which the...
In January when the FDA unveiled its 25-point plan to change the 510(k) clearance program, currently the quickest and most commonly used pathway to getting a medical device to market in the U.S., it appeared that a smooth landing might be in the works for the med-tech industry. That landing, however, was deferred, saddling the program with one of the greatest annoyances to any airline passenger, the dreaded holding pattern, when it was revealed that 30 other more controversial recommendations from the FDA working groups were being delayed. Among the most contentious recommendations being postponed was one for CDRH...