Massachusetts governor Deval Patrick signed into law new regulations surrounding devicemakers' gifts to physicians. Per the new law, manufacturers must disclose in an annual report any gifts given in Massachusetts that are worth more than $50. According to FDA News,... more
The medical device industry has been closely following progress on the Physician Payment Sunshine Act (S. 2029), which is currently under review in Congress and intends to increase transparency in the relationship between physicians and manufactures. This bill was first... more
Last month, the Supreme Court ruled in Riegel v. Medtronic that FDA approval pre-empted product-liability lawsuits in state courts. The landmark decision was a vote of support for the FDA's authority, but it raised concerns about the implications for patient... more
Earnings Artimplant reported 4Q:07 revenues of SEK 5.0 million ($0.8 million), up from SEK 1.6 million ($0.25 million) in the year-ago period. The net loss for 4Q:07 was SEK 2.1 million ($0.34 million), improved from a loss of SEK 9.5... more
In the January 30th issue of the New York Times, healthcare reporter Reed Abelson takes a critical look at spine surgery, and in particular a novel device called Prodisc in an article titled "Financial Ties Are Cited as Issue in... more
Senators Charles Grassley (R-IA) and Arlen Specter (R-PA) are sponsoring a bill that would require manufacturers of implantable medical devices to provide quarterly data on the average and median selling prices for devices used in both inpatient and outpatient procedures.... more
Last week's Medical Device Manufacturers Association Annual Meeting in Washington, D.C. gave us an opportunity to applaud the passion and dedication that defined MDMA's past accomplishments and will carry future negotiations on regulatory, reimbusement and marketplace issues for smaller device... more
With a small market and conditions that are relatively rare, pediatrics hasn't drawn a lot of product development in the device space. As a result, children may receive devices that aren't appropriately sized for them or are lacking in data... more
A new bill was introduced in the New Jersey state legislature earlier this month that would allow patients to decide if they want to receive a reprocessed medical device. A similar bill was introduced in Massachusetts last year, but it... more
This afternoon MDMA held its monthly call, outlining policy changed that are on the horizon for 2007. We've outlined some of their comments below: MDUFMA Negotations for MDUFMA II have been ongoing since February of 2006. The FDA has recently... more
Asia's continued economic growth makes it an attractive market for both the sale and manufacture of medical devices. Pacific Bridge Medical, a medical consulting firm focusing on business development and regulatory affairs in Asia, recently published an article on the... more
Fact: GPO-negotiated contacts drive more than $100 billion in device purchases by hospitals. News Item: The DOJ, the Connecticut Attorney General, three U.S. Senators, and the New York Times call for GPO reform. Takeaway: GPO market reform will change your... more
This week CMS proposed a 5.1% reduction in payments to physicians for 2007. The proposal will impact the 875,000 doctors who care for the elderly and disabled in the US. The explanation for the cut is that spending on physician... more
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