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Device Regulation Alert: Safety, Compliance and Reimbursement News Pharma Compliance Alert
Device Regulation Alert: Safety, Compliance and Reimbursement News
Published weekly, this free e-newsletter offers up-to-date information on hot topics and trends effecting the medical device and diagnostics industry. With a subscription to Device Regulation Alert, you will get comprehensive coverage of device regulation, compliance and risk management.
Issue 15, May 9, 2009
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Editor's Note: Final issue of Device Regulation Alert today
HCPro is sorry to announce that this is the final issue of Device Regulation Alert. We thank you... -
Device maker settles allegations it failed to disclose payments to physicians
Medical device maker Synthes, Inc., based in West Chester, PA, entered into a settlement agreement... -
Disetronic Medical Systems recalls insulin pumps
Disetronic Medical Systems issued a recall for its ACCU-CHEK Spirit insulin pumps with serial... -
FDA sends warning letter to Nidek Medical Products
Nidek Medical Products failed to properly document complaints about the company's oxygen... -
IOM calls for end to industry support
The Institute of Medicine (IOM) became the latest organization to call for an end to medical device...
Issue 14, April 27, 2009
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Third former device employee pleads guilty to misbranding
Shane Doyle, 32, of Winchester, MA, pleaded guilty to felony misbranding, according to the... -
St. Jude warned about manufacturing problems
St. Jude Medical received an FDA warning letter citing manufacturing problems mainly related to the... -
Biomet under investigation for possible fraud
Government investigators are examining allegations that Biomet improperly sold, promoted, and... -
Smith & Nephew receives subpoena from DOJ
The Department of Justice subpoenaed documents relating to Smith & Nephew’s ultrasound... -
Quest to pay $302M for subsidiary's alleged misbranding
Quest Diagnostics and its subsidiary, Nichols Institute Diagnostics (NID) will pay $302 million to... -
Arrow recalling intra-aortic balloons
Arrow International recalled 45,211 units of volume connectors for its 30-, 40- and 50-cc... -
Business associates: HIPAA survey
We want to hear from business associates about their need for HIPAA training. Business associates...
Issue 13, April 13, 2009
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FDA to review risks for older devices
Manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and... -
Massachusetts disclosure requirements a first for medical device manufacturers
Massachusetts is the first state to require medical device companies to disclose financial... -
Johns Hopkins bans gifts
A new Johns Hopkins Medicine (JHM) policy prohibits physicians, scientists, students, and staff... -
Stanford to disclose payments from device makers
Stanford University School of Medicine will reveal which of the 1,200 physicians and faculty... -
ZOLL issues corrective action for automated external defibrillators
ZOLL Medical Corporation initiated a voluntary field corrective action for 180,000 ZOLL AED Plus... -
Charges dropped against four device makers after DPAs expire
The Department of Justice (DOJ) dropped criminal conspiracy charges against Zimmer, Depuy... -
FDA: Medtronic voluntary recall of catheter is Class I recall
The FDA is classifying Medtronic’s voluntary recall for three models of the BioGlide...
Issue 12, March 30, 2009
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Judge dismisses suit against Allergan citing preemption
A federal judge cited the February 2008 Supreme Court ruling in favor of preemption for medical... -
FDA issues draft guidance on user fees
New FDA draft guidance includes user fee and user-fee refund information for 30-day notices and... -
Groups agree on clinical credentialing standard
AdvaMed and 10 other healthcare organizations are working together to create national standards for... -
Boston Scientific settles patent dispute
Boston Scientific will take a $50 million pre-tax charge to its earnings to settle all outstanding... -
Welch Allyn recalls external defibrillators
Welch Allyn’s AED 10 and MRL JumpStart external defibrillators may experience low energy...
Issue 11, March 16, 2009
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Editor's Note
Beginning with this week’s issue, Device Regulation Alert will be published every other week... -
Massachusetts finalizes disclosure regulations
The Massachusetts Public Health Council (PHC) finalized regulations March 11 governing the sales... -
Stryker under investigation for alleged illegal promotion
A Massachusetts grand jury is investigating a Stryker subsidiary’s promotion of its human... -
FDA issues warning about transdermal patches and MRI
Transdermal drug patches with metallic backing can overheat during an MRI scan and cause skin burns...
Issue 10, March 9, 2009
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Congress aims to eliminate preemption of state lawsuits
One day after the US Supreme Court ruled FDA approval does not shield pharmaceutical companies from... -
DOJ investigating Medtronic marketing
The Department of Justice (DOJ) is investigating Medtronic’s promotion of its cardiac...
Issue 9, March 2, 2009
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Medtronic to disclose payments for physicians
Medtronic is taking another step towards transparency by voluntarily disclosing payments to... -
Cardinal Health modifies consent decree with FDA
Cardinal Health will thoroughly review all of its infusion pump products within 60 days and submit...
Issue 8, February 23, 2009
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Wisconsin Supreme Court sides with Medtronic
FDA approval preempts patients’ rights to sue medical device manufacturers for potentially... -
Non-profit group criticizes FDA for ignoring GLPs
The FDA is putting patient lives at risk by failing to enforce good laboratory standards (GLPs...
Issue 7, February 16, 2009
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NeuroMetrix resolves kickback allegations
Device maker NeuroMetrix, based in Waltham, MA, agreed to pay a $1.2 million criminal fine to... -
Device sales rep pleads guilty to misbranding
Justin Demming, of Wadsworth, OH, pleaded guilty to felony misbranding of a medical device... -
FDA's final guidance clarifies reprint guidelines
In January, the FDA provided some much needed guidance for the medical device industry about when...
Issue 5, February 2, 2009
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InnoMed receives FDA warning letter for alleged GMP violations
InnoMed failed to abide by current Good Manufacturing Practices (GMPs) at its Coconut Creek, FL... -
Spine society adopts disclosure policy
Physicians participating in North American Spine Society (NASS) activities will have to disclose... -
Transparency coming to Harvard
Harvard Medical School could follow the example of Stanford University, the University of... -
FDA releases updated draft guidance for ANA test systems
New developments for in vitro diagnostic devices prompted the FDA to release a revised guidance... -
Credible reports of compliance violations come from walk-ins
Employees who walk in to the compliance officer’s office to report a suspected compliance...
Issue 4, January 26, 2009
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Senators reintroduce disclosure law
Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) continue to push for national legislation... -
Minnesota health system to require disclosure of industry ties
Park Nicollet Health Services, located in Minnesota, will begin requiring physicians to disclose... -
Class III devices may require PMA
Medical device manufacturers may soon be required to submit all class III devices to the more...
Issue 3, January 19, 2009
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Device maker sues physician for slander
NMT Medical, a Boston medical device manufacturer, filed suit against British researcher Dr. Peter... -
Medtronic paid researcher $19M
Senator Charles Grassley (R-IA) continues to scrutinize payments from medical device makers to...
Issue 2, January 12, 2009
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Judges dismisses cases against Medtronic
U.S. District Judge Richard Kyle dismissed dozens of patient lawsuits against Medtronic, saying the... -
FDA issues guidance on enterovirus nucleic acid assays
Any firm that submits a 510(k) for enterovirus nucleic acid assays must show that its device...
Issue 1, January 5, 2009
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AdvaMed updates Code of Ethics
AdvaMed further clarified what constitutes appropriate interactions between the medical device... -
Edwards Lifesciences to disclose physician payments
Edwards Lifesciences will begin voluntarily disclosing payments to physicians this year, according...