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  • Regulatory NewsRegulatory News

    Medtronic Settles Deceptive Advertising Lawsuit for $12M

    State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multi-state settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse. The complaint alleged that Medtronic used deceptive company-sponsored scientific literature to convey false and misleading claims about the device’s safety, comparative efficacy and superiority to expand its market. Spec...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Indian Watchdog Probes Allegations Roche Tried to Influence Regulators (2 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Indian Antitrust Watchdog Probes Allegations Roche Tried to Influence Regulators The Indian antitrust watchdog has begun an investigation into allegations Roche tried to influence regulatory agencies and otherwise stop biosimilar copies of Herceptin from gaining market share. Roche is accused of seeking to influence the office of the Drug Controller General of India (...
  • Regulatory NewsRegulatory News

    FDA Approves First Automated Insulin Delivery Device

    The US Food and Drug Administration (FDA) on Wednesday approved Medtronic’s artificial pancreas, known as the MiniMed 670G hybrid closed looped system, which is the first device approved in the US to automatically monitor glucose and provide appropriate basal insulin doses in people 14 and older with type 1 diabetes. The system is intended to adjust insulin levels with little or no input from the user, and works by measuring glucose levels every five minutes and automati...
  • Regulatory NewsRegulatory News

    FDA Warns Medtronic Subsidiary Over Adulterated Devices

    Highlighting validation concerns and the distribution of adulterated devices with nonconformities, the US Food and Drug Administration (FDA) earlier this month sent a warning letter to Medtronic subsidiary Tyrx. The letter, dated 2 June, follows an inspection of the company’s Monmouth Junction, NJ-based site from 30 November 2015 through 12 February 2016, with respect to Tyrx’s Antibacterial Envelope, Antibacterial Absorbable Envelope, which is intended to reduce the cha...
  • Regulatory NewsRegulatory News

    EMA Recommends Suspending Medtronic's Inductos Over GMP Issues at CMO

    The European Medicines Agency (EMA) is calling on the European Commission to suspend the marketing authorization for Inductos, Medtronic's implant used to help new bone growth in patients with spinal disc problems and leg fractures. The recommendation comes after a follow up inspection of a US manufacturing site was found to be "non-compliant with manufacturing requirements [and] did not have adequate measures in place to prevent particle contamination." While EMA notes...
  • Regulatory NewsRegulatory News

    EMA to Review InductOs After US Manufacturer Cited for Contamination Issues

    The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs, after Spanish and Dutch inspectors discovered contamination issues at a US manufacturing site which makes one of its components. Background InductOs was authorized via the centralized procedure in 2002 and is marketed by Medtronic BioPharma B.V., headquartered in the Netherlands. InductOs is used to promote bone development in pati...
  • How the Failure of Medtronic's Symplicity Device Spells Trouble for FDA

    One of the US Food and Drug Administration's (FDA) marquee pilot programs may now be in jeopardy through no fault of its own after the apparent failure of the flagship device that was meant to test the capabilities of the program. The Program The program in question is known as Parallel Review , and was created in October 2011 as a way to allow companies to get their products from an investigational stage to reimbursement more quickly. At present, FDA's approval proc...
  • Senate Investigation Claims Medtronic Edited, Influenced Studies

    • 25 October 2012
    A new report released by the Senate Finance Committee slams medical device manufacturer Medtronic for allegedly ghostwriting studies used to support its Infuse Bone Graft system and paying hundreds of millions of dollars to experts who authored company-sponsored studies. The 2,300-page report (PDF, 150 MB) was triggered in part by a 2009 investigation conducted by Med Page Today and the Milwaukee Journal-Sentinel that found the company to have engaged in ghostwri...
  • Medtronic Receives Warning Letter for Alleged CAPA Problems

    Medical device manufacturing giant Medtronic was hit with a warning letter from the US Food and Drug Administration (FDA) on 17 July regarding allegedly deficient operations at its Minneapolis-based Medtronic Neuromodulation manufacturing facility. The letter , addressed to Chief Executive Officer Omar Ishrak, references a May 2012 inspection by FDA in which investigators found the facility's adherence to current good manufacturing practices (CGMPs) and Quality System...
  • Report: FDA Developing UDI Barcode System for Medical Devices

    A report in The Wall Street Journal and The Gray Sheet indicate the US Food and Drug Administration (FDA) is working to develop and roll out a Unique Device Identification (UDI) system. The policy- long in development and long held-up at the White House's Office of Management and Budget (OMB)-was mandated under the Food and Drug Administration Amendments Act (FDAAA) and is intended to standardize how medical devices are tracked. FDA has been attempting to harmo...
  • After Regulatory Issues Raised, Medtronic Plans to Heighten Postmarketing Safety Monitoring

    After a string of "headline-grabbing" recalls involving medical devices in recent months, Minneapolis-based medical device manufacturer Medtronic is announcing its intent to increase its postmarketing safety surveillance of its implantable products, reports Reuters . "The US Food and Drug Administration (FDA) alone does not have the infrastructure," said Medtronic CEO Omar Ishrak in an interview with Reuters , "so companies have to play a leading role in this." "We ne...
  • Report: Postmarketing Regulatory Troubles at St. Jude Depress Share Value

    The regulatory issues faced by St. Jude as a result of unfavorable reports concerning the safety of its Riata defibrillator leads-as well as the company's cessation of sales for its Quicksite and QuickFlex defibrillator leads-are causing more than just publicity problems for the company, reports Reuters . The regulatory issues are "raising concerns on Wall Street that doctors will curb use of the company's products, weakening its position in the $6.5 billion global mark...