Regulatory News

  1. EU Council Unanimously Adopts New Med Device, IVD Regs

    On 7 March 2017, the Council adopted new EU rules improving the safety of medical devices for the benefit of patients while preserving a timely access to innovative healthcare solutions.

  2. FDA Approves Abbott's FlexAbility Ablation Catheter For Treating Atrial Flutter

    The catheter is designed to work with the company's EnSite Precision cardiac mapping system and MediGuide Technology to safely treat atrial flutter, a condition similar to atrial fibrillation, the most common heart rhythm disorder.

  3. NxStage Medical’s Next-Gen Hemodialysis System Gains CE Mark Approval

    NxStage Medical, Inc. (NASDAQ: NXTM), a leading medical technology company focused on advancing renal care, today announced that its next generation hemodialysis system has received CE Mark approval.

  4. AdvaMed Proposes Two New Safe Harbors Under Federal Anti-Kickback Statute For Value-Based Arrangements

    The Advanced Medical Technology Association (AdvaMed) is proposing two new safe harbors to the federal anti-kickback statute that aims to protect value-based pricing arrangements and value-based warranties.

  5. Velano Vascular Snags Third FDA Clearance For Needle-Free Blood Draw Device

    Velano Vascular announced that the company has secured a third FDA 510(k) clearance for its next-generation design of PIVO, a device that can collect blood samples through peripheral intravenous (IV) lines, preventing additional and unnecessary needle sticks for hospitalized patients.

  6. ViewRay’s Next-Gen MRI-Guided Radiation Therapy System Cleared By FDA

    Announces Fourth Quarter and Full Year 2016 Financial Highlights, including Record Revenue and $133.2 million in Backlog ViewRay, Inc. (Nasdaq: VRAY) announced today that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MRIdian Linac system, the company's next generation linear accelerator-based MRI-guided radiation therapy system.

  7. Philips’ Noninvasive Liver Assessment Tool Cleared By FDA

    Royal Philips, a global leader in health technology, recently announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ElastQ Imaging capability, further expanding the functionalities of its EPIQ family of ultrasound systems.

  8. EU Finalizes Revamped Medical Device, IVD Regulations

    The Council of the European Union has completed the final versions of its long-awaited Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR), which update the regulatory framework for the marketing of medical devices and in vitro diagnostics in Europe, the world’s second-largest device market.

  9. Medtronic’s Next-Gen Cardiac Resynchronization Therapy-Pacemakers Gain CE Mark Approval

    Medtronic plc recently announced that it has received CE (Conformité Européenne) Mark for a suite of quadripolar cardiac resynchronization therapy pacemakers (CRT-Ps) that also allow patients to receive MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines.

  10. Seventh Sense Biosystems’ “Virtually Painless” Blood Draw Cleared By FDA

    Seventh Sense Biosystems, Inc. (7SBio) announced today that a new blood collection device called TAP has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The technology represents a landmark innovation in the blood collection industry where one billion blood draws are performed each year for diagnostic testing.