Life Sciences Articles by Topic: Medical Devices
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 15, May 9, 2009
Medical device maker Synthes, Inc., based in West Chester, PA, entered into a settlement agreement...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 15, May 9, 2009
Disetronic Medical Systems issued a recall for its ACCU-CHEK Spirit insulin pumps with serial...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 15, May 9, 2009
Nidek Medical Products failed to properly document complaints about the company's oxygen...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 15, May 9, 2009
The Institute of Medicine (IOM) became the latest organization to call for an end to medical device...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009
The Department of Justice subpoenaed documents relating to Smith & Nephew’s ultrasound...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009
Shane Doyle, 32, of Winchester, MA, pleaded guilty to felony misbranding, according to the...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009
St. Jude Medical received an FDA warning letter citing manufacturing problems mainly related to the...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009
Government investigators are examining allegations that Biomet improperly sold, promoted, and...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009
Quest Diagnostics and its subsidiary, Nichols Institute Diagnostics (NID) will pay $302 million to...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009
Arrow International recalled 45,211 units of volume connectors for its 30-, 40- and 50-cc...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 13, April 13, 2009
Manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 13, April 13, 2009
Massachusetts is the first state to require medical device companies to disclose financial...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 13, April 13, 2009
A new Johns Hopkins Medicine (JHM) policy prohibits physicians, scientists, students, and staff...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 13, April 13, 2009
Stanford University School of Medicine will reveal which of the 1,200 physicians and faculty...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 13, April 13, 2009
ZOLL Medical Corporation initiated a voluntary field corrective action for 180,000 ZOLL AED Plus...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 13, April 13, 2009
The Department of Justice (DOJ) dropped criminal conspiracy charges against Zimmer, Depuy...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 13, April 13, 2009
The FDA is classifying Medtronic’s voluntary recall for three models of the BioGlide...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 12, March 30, 2009
New FDA draft guidance includes user fee and user-fee refund information for 30-day notices and...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 12, March 30, 2009
AdvaMed and 10 other healthcare organizations are working together to create national standards for...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 12, March 30, 2009
Boston Scientific will take a $50 million pre-tax charge to its earnings to settle all outstanding...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 12, March 30, 2009
Welch Allyn’s AED 10 and MRL JumpStart external defibrillators may experience low energy...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 11, March 16, 2009
The Massachusetts Public Health Council (PHC) finalized regulations March 11 governing the sales...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 11, March 16, 2009
Beginning with this week’s issue, Device Regulation Alert will be published every other week...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 11, March 16, 2009
A Massachusetts grand jury is investigating a Stryker subsidiary’s promotion of its human...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 11, March 16, 2009
Transdermal drug patches with metallic backing can overheat during an MRI scan and cause skin burns...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 10, March 9, 2009
One day after the US Supreme Court ruled FDA approval does not shield pharmaceutical companies from...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 10, March 9, 2009
The Department of Justice (DOJ) is investigating Medtronic’s promotion of its cardiac...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 9, March 2, 2009
Medtronic is taking another step towards transparency by voluntarily disclosing payments to...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 9, March 2, 2009
Cardinal Health will thoroughly review all of its infusion pump products within 60 days and submit...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 8, February 23, 2009
FDA approval preempts patients’ rights to sue medical device manufacturers for potentially...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 8, February 23, 2009
The FDA is putting patient lives at risk by failing to enforce good laboratory standards (GLPs...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 7, February 16, 2009
Device maker NeuroMetrix, based in Waltham, MA, agreed to pay a $1.2 million criminal fine to...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 7, February 16, 2009
Justin Demming, of Wadsworth, OH, pleaded guilty to felony misbranding of a medical device...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 7, February 16, 2009
In January, the FDA provided some much needed guidance for the medical device industry about when...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 5, February 9, 2009
Harvard Medical School could follow the example of Stanford University, the University of...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 5, February 9, 2009
New developments for in vitro diagnostic devices prompted the FDA to release a revised guidance...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 5, February 2, 2009
Physicians participating in North American Spine Society (NASS) activities will have to disclose...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 5, February 2, 2009
InnoMed failed to abide by current Good Manufacturing Practices (GMPs) at its Coconut Creek, FL...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 5, February 2, 2009
Employees who walk in to the compliance officer’s office to report a suspected compliance...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 4, January 26, 2009
Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) continue to push for national legislation...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 4, January 26, 2009
Park Nicollet Health Services, located in Minnesota, will begin requiring physicians to disclose...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 4, January 26, 2009
Medical device manufacturers may soon be required to submit all class III devices to the more...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 3, January 19, 2009
NMT Medical, a Boston medical device manufacturer, filed suit against British researcher Dr. Peter...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 3, January 19, 2009
Senator Charles Grassley (R-IA) continues to scrutinize payments from medical device makers to...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 2, January 12, 2009
Any firm that submits a 510(k) for enterovirus nucleic acid assays must show that its device...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 2, January 12, 2009
U.S. District Judge Richard Kyle dismissed dozens of patient lawsuits against Medtronic, saying the...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 1, January 5, 2009
AdvaMed further clarified what constitutes appropriate interactions between the medical device...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 1, January 5, 2009
Edwards Lifesciences will begin voluntarily disclosing payments to physicians this year, according...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 52, December 29, 2008
Healthcare industry credentialing requirements place a financial and administrative burden on...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 51, December 22, 2008
The FDA provided new criteria for medical device manufacturers to determine what type of pre-market...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 51, December 22, 2008
A Minnesota state senator would like to see the state’s disclosure law expand to include...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 50, December 15, 2008
Terumo Cardiovascular Systems issued a Class I recall for 21 lots of its Tenderflow Pediatric...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 50, December 15, 2008
Innovative Neurotronics did not completely resolve problems uncovered by an FDA inspection...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 50, December 15, 2008
The relationship between the surgeon and the sales representative is vital to patient care...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 50, December 15, 2008
The Massachusetts Public Health Council released a draft of regulations regulating medical device...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 49, December 8, 2008
The Prescription Project, a non-profit watchdog group, petitioned the FDA to require Abbott...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 49, December 8, 2008
Senator Charles Grassley (R-IA) wants to know if a Northwestern University teaching hospital...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 49, December 8, 2008
Cleveland Clinic is taking its own steps toward transparency regarding physicians’ ties to...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 49, December 8, 2008
During fiscal year (FY) 2008, government enforcement efforts led to 455 criminal actions and 337...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 48, December 1, 2008
Darnell Martin, 35, of Chicago, pleaded guilty to one count of making a false statement and one...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 48, December 1, 2008
Animas is recalling battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 47, November 24, 2008
The Department of Justice (DOJ) is looking into the off-label use of Medtronic’s Infuse Bone...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 47, November 24, 2008
The FDA outlines labeling recommendations for natural rubber latex condoms without spermicidal...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 46, November 17, 2008
The Department of Justice (DOJ) recovered $1.34 billion through fraud and false claims settlements...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 46, November 17, 2008
MP3 player headphones can cause potentially dangerous interactions with implantable cardiac...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 46, November 17, 2008
The Department of Justice (DOJ) is investigating allegations that AtriCure, Inc., improperly...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 45, November 10, 2008
Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) are looking into Johnson &...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 45, November 10, 2008
CMS did not include gainsharing its 2009 Medicare Physician Fee Schedule and Hospital Outpatient...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 44, November 3, 2008
Thoratec issued a worldwide correction for some of its HeartMate II Left Ventricular Assist...
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Pharma Compliance Alert, Issue 43, October 29, 2008
The University of Minnesota is considering one of the strictest bans on gifts from the...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 43, October 27, 2008
Nine surgical mesh manufacturers submitted more than 1,000 reports of complications associated with...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 42, October 20, 2008
Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) are looking into industry payments to...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 42, October 20, 2008
Expanded outreach efforts could help the FDA mitigate barriers to recruiting qualified advisory...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 42, October 20, 2008
The FDA cited C.R. Bard for failing to meet current Good Manufacturing Practices at its Humacao...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 1, October 13, 2008
Laboratory Corporation of America (LabCorp) is illegally marketing a blood test to detect ovarian...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 3, October 13, 2008
McKesson, North America’s largest durable medical equipment (DME) supplier, defrauded...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 40, October 6, 2008
The FDA considers Medtronic’s safety alert about the proper connection of sutureless...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 40, October 6, 2008
General Electric’s (GE) Centricity Imaging and other Picture Archiving
and Communication...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 40, October 6, 2008
Senator Charles Grassley (R-IA) accused well-known Tufts University heart specialist Marvin...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 39, September 29, 2008
Former Medtronic senior legal counsel Ami P. Kelley filed a lawsuit claiming the company offered...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 39, September 29, 2008
Fall Prevention Technologies failed to follow current Good Manufacturing Practices for its...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 39, September 29, 2008
Physicians and patients obtain most of their information about products online, said James M. Wood...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 39, September 26, 2008
Medical device manufacturers should use a randomized, controlled trial to collect data to...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 38, September 22, 2008
Clinical or medical personnel should be on hand at trade shows to provide information about...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 38, September 22, 2008
Kimberly-Clark significantly changed 12 models of previously approved sterilization wraps and...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 38, September 22, 2008
For the second time, the FDA is reopening the comment period on its proposed guidance concerning...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 38, September 22, 2008
Senator Herb Kohl (D-WI) questioned the American College of Cardiology’s (ACC) ability to...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 37, September 15, 2008
Medtronic posted a list of its charitable donations online for the first time, in part because of...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 37, September 15, 2008
The FDA and Immigration and Customs Enforcement executed a search warrant at Spectranetics...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 37, September 15, 2008
Medtronic became the fourth major manufacturer investigated for improperly marketing its bile duct...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 37, September 15, 2008
O’Ryan Industries allegedly distributed its Endo 150 endoscopic light source and Omega ST...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 36, September 8, 2008
The Department of Justice (DOJ) recovered at least $9.3 billion in healthcare fraud with help from...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 36, September 8, 2008
Rotech Healthcare paid $2 million to resolve allegations it defrauded Medicare in billing for...
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Pharma Compliance Alert, Issue 35, September 3, 2008
Stanford became the latest academic institution to limit how much funding it will accept from...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 35, September 1, 2008
Stryker Corp. is suing the Department of Justice (DOJ) and Office of Inspector General (OIG) for...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 35, September 1, 2008
The FDA will require device manufacturers to track thoracic aortic aneurysm stent grafts, according...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 35, September 1, 2008
Innovators and healthcare providers can now find answers to questions about coverage, coding, and...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 44, January 3, 2008
BioMedix Vascular Solutions failed to follow current Good Manufacturing Practices at its St. Paul...