WARSAW, Ind. – (Business Wire) On July 28, 2010, Biomet received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding the Signature™ Personalized Patient Care system, alleging that Biomet does not have appropriate clearance or approval to market the system in the United States.
Biomet responded to the Warning Letter on… Continue reading »
Federal investigators are looking into payments to foreign physicians by at least three major medical device makers and several pharmaceutical firms, examining whether the practice runs afoul of the Foreign Corrupt Practices Act.
G-men want the skinny on consulting arrangements by companies including Medtronic Inc. (NYSE:MDT), Zimmer Holdings (NYSE:ZMH) and Johnson & Johnson (NYSE:JNJ)… Continue reading »
The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to… Continue reading »
It was a rare, stinging setback for medical device and supply companies, including dozens in Indiana that make hospital beds, stents, biopsy needles, artificial joints and thousands of other products used in hospitals and doctors’ offices.
Despite spending tens of millions to lobby federal lawmakers and in campaign contributions, the companies lost a… Continue reading »
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An omnibus economic development bill wending its way through the Mass. House of Representatives would put paid to the Bay State’s two-year-old “gift ban” governing the relationship between the medical device and pharmaceutical industries and physicians.
The gift ban, passed in 2008 and put into effect last year, was aimed at reducing the influence… Continue reading »
A Southwest Airlines employee called police after finding human heads in a package set to be transported to a Fort Worth medical research company, the airline said.
“It wasn’t labeled or packaged properly,” said Ashley Rogers, a Southwest spokeswoman. “They called the local authorities.”
The incident happened in … Continue reading » | 2 Comments
A federal judge in Michigan tossed a whistleblower lawsuit against Stryker Corp. (NYSE:SYK) that accused the company of a kickbacks scheme, but gave the plaintiffs a window to amend their complaint.
Judge Robert Jonker of the U.S. District Court for Western Michigan ruled that Robert Laucirica and the U.S. government failed to prove their… Continue reading »
The Senate today voted 59 to 38 to delay a 21.2 percent Medicare physician pay cut from April 1 to June 1. The postponement came as part of a larger bill that extends unemployment compensation and COBRA subsidies for health insurance premiums. Several hours later, the House voted 289 to 112 to enact the bill… Continue reading »
Once again, on Thursday, physicians will face a huge cut in Medicare reimbursements resulting from Congress’ failure to extend a short-term patch to delay implementing the sustainable growth rate formula.
Congress went on a two-week recess on Friday without taking action, but CMS has promised to hold off what now amounts to a 21.3… Continue reading »
BURR RIDGE, Ill., March 23 /PRNewswire-USNewswire/ — In a survey published by the North American Spine Society (NASS), as many as 24 percent of spine care physicians participating in Medicare indicated they will no longer participate in the program if the mandated reductions in Medicare reimbursement to physicians occur later this year. Additionally, more than one-third of… Continue reading »
WASHINGTON, March 23 (Reuters) – President Barack Obama sealed a hard-fought victory on Tuesday by signing into law a landmark healthcare reform measure that will help shape his legacy and the Democrats’ chances of holding power in the U.S. Congress.
“We have now just enshrined… the core principle that everybody should have some basic… Continue reading »
FDA NEWS RELEASE
For Immediate Release: Jan. 22, 2010
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices
February Meeting will Complement IOM Study
The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb… Continue reading »
Medical-device companies could benefit from an improving economy and a clearer view of health-system changes this year, but they will still have to contend with plenty of challenges.
These include toughening regulatory oversight, hospitals battling high device prices, an expected multibillion-dollar tax as part of health-overhaul legislation, and no big innovations to invigorate sales… Continue reading »