Life Sciences Articles by Topic: Medical Devices

Device maker settles allegations it failed to disclose payments to physicians

• 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...

Disetronic Medical Systems recalls insulin pumps

• 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...

FDA sends warning letter to Nidek Medical Products

• 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...

IOM calls for end to industry support

• 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...

Smith & Nephew receives subpoena from DOJ

• 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...

Third former device employee pleads guilty to misbranding

• 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...

St. Jude warned about manufacturing problems

• 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...

Biomet under investigation for possible fraud

• Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009

  Government investigators are examining allegations that Biomet improperly sold, promoted, and...

Quest to pay $302M for subsidiary's alleged misbranding

• 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...

Arrow recalling intra-aortic balloons

• 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...

FDA to review risks for older devices

• 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...

Massachusetts disclosure requirements a first for medical device manufacturers

• 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...

Johns Hopkins bans gifts

• 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...

Stanford to disclose payments from device makers

• 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...

ZOLL issues corrective action for automated external defibrillators

• 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...

Charges dropped against four device makers after DPAs expire

• 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...

FDA: Medtronic voluntary recall of catheter is Class I recall

• 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...

FDA issues draft guidance on user fees

• 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...

Groups agree on clinical credentialing standard

• 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...

Boston Scientific settles patent dispute

• 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...

Welch Allyn recalls external defibrillators

• 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...

Massachusetts finalizes disclosure regulations

• 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...

Editor's Note

• 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...

Stryker under investigation for alleged illegal promotion

• 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...

FDA issues warning about transdermal patches and MRI

• 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...

Congress aims to eliminate preemption of state lawsuits

• 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...

DOJ investigating Medtronic marketing

• 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...

Medtronic to disclose payments for physicians

• 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...

Cardinal Health modifies consent decree with FDA

• 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...

Wisconsin Supreme Court sides with Medtronic

• 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...

Non-profit group criticizes FDA for ignoring GLPs

• 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...

NeuroMetrix resolves kickback allegations

• 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...

Device sales rep pleads guilty to misbranding

• 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...

FDA's final guidance clarifies reprint guidelines

• 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...

Transparency coming to Harvard

• 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...

FDA releases updated draft guidance for ANA test systems

• 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...

Spine society adopts disclosure policy

• 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...

InnoMed receives FDA warning letter for alleged GMP violations

• 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...

Credible reports of compliance violations come from walk-ins

• 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...

Senators reintroduce disclosure law

• 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...

Minnesota health system to require disclosure of industry ties

• 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...

Class III devices may require PMA

• 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...

Device maker sues physician for slander

• 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...

Medtronic paid researcher $19M

• 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...

FDA issues guidance on enterovirus nucleic acid assays

• 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...

Judges dismisses cases against Medtronic

• 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...

AdvaMed updates Code of Ethics

• Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 1, January 5, 2009

  AdvaMed further clarified what constitutes appropriate interactions between the medical device...

Edwards Lifesciences to disclose physician payments

• 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...

Credentialing requirements raise kickback concerns

• Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 52, December 29, 2008

  Healthcare industry credentialing requirements place a financial and administrative burden on...

FDA issues final guidance on submissions of PMA supplements

• 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...

MN considering device disclosure requirements

• 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...

Terumo Cardiovascular Systems recalls pediatric arterial cannulae

• 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...

FDA: Innovative Neurotronics' response to warning letter incomplete

• 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...

Credentialing requirements continue to be concern for industry

• 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...

Massachusetts council releases draft disclosure regulations

• 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...

Citizen group accuses device makers of illegal online marketing

• 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...

Senator investigating use of unapproved device

• 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...

Cleveland Clinic to post physician ties to industry

• 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...

OIG releases Semiannual Report to Congress

• 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...

Former medical device manager pleads guilty to misbranding

• 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...

Animas issues Class I recall for battery caps

• 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...

Government investigating off-label use of Medtronic device

• 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...

FDA issues special control guidance for condoms

• 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...

DOJ recovers $1.34B in fraud, false claims in FY 2008

• 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...

Headphones interfere with pacemakers, defibrillators

• Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 46, November 17, 2008

  MP3 player headphones can cause potentially dangerous interactions with implantable cardiac...

DOJ investigating AtriCure marketing

• 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...

Senators investigating J&J payments

• 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 &...

CMS delays gainsharing

• 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...

Thoratec initiates recall of heart device

• 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...

University of Minnesota considers gift ban

• Pharma Compliance Alert, Issue 43, October 29, 2008

  The University of Minnesota is considering one of the strictest bans on gifts from the...

FDA issues public health watch for transvaginal placement of surgical mesh

• 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...

Senators continue to investigate industry, physician ties

• 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...

GAO: FDA advisory boards would benefit from more outreach

• 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...

C.R. Bard receives FDA warning letter

• 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...

LabCorp receives FDA warning letter

• 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...

McKesson accused of Medicare fraud

• Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 3, October 13, 2008

  McKesson, North America’s largest durable medical equipment (DME) supplier, defrauded...

Medtronic notification classified as Class I recall

• 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...

GE warned for violating cGMPs

• 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...

Grassley questions NIH hiring of Tufts University professor

• 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...

Kickback allegations by former Medtronic attorney revealed

• 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...

Fall Prevention receives warning letter

• 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...

Internet promotion subject to FDA review

• 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...

FDA releases draft guidance for trials of incontinence devices

• 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...

Trade shows present potential promotional pitfalls

• 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...

FDA warns Kimberly-Clark

• 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...

FDA reopens comment period for hemostatic devices

• 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...

Senator questions ties between industry, cardiology group

• 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...

Medtronic posts list of donations

• 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...

Spectranetics under investigation

• 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...

Medtronic marketing investigated

• 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...

O'Ryan Industries receives warning letter

• 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...

DOJ recovers $9.3B in healthcare fraud

• 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...

Rotech settles fraud charges

• 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...

Stanford to stop accepting industry funding for CME

• Pharma Compliance Alert, Issue 35, September 3, 2008

  Stanford became the latest academic institution to limit how much funding it will accept from...

Stryker files suit against DOJ, OIG

• 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...

FDA adds device to tracking list

• 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...

CMS issues guidance for innovators

• 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...

BioMedix receives FDA warning letter

• 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...