Regulatory News

  1. FDA Clears Game Ready's Multi-Modality Recovery Device 10/6/2017

    The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elite™.

  2. FDA Approves Implantable To Treat Central Sleep Apnea 10/6/2017

    The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea.

  3. FDA Clears K2M's YUKON OCT Spinal System 9/29/2017

    K2M Group Holdings, Inc.(NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its YUKON™ OCT Spinal System.

  4. Subchondral Solutions' Screw System For Osteochondral Joint Fractures Cleared By FDA 9/29/2017

    Subchondral Solutions, Inc. -- a medical device company-- has just received 510(k) clearance from the Food and Drug Administration (FDA) for its S4 Screw System™. The S4 Screw System™ is a fenestrated cannulated family of screws specifically designed for osteochondral fractures of the joint.

  5. FDA Approves Medtronic's HeartWare HVAD System For Destination Therapy 9/27/2017

    Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for its HeartWare HVAD System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants.

  6. Abbott's FreeStyle Libre Flash Glucose Monitoring System Approved By FDA 9/27/2017

    Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the FreeStyle® Libre Flash Glucose Monitoring System as a replacement for blood glucose monitoring (BGM) for adults with diabetes in the U.S.

  7. Boston Scientific Launches Resonate Devices With HF Diagnostic In U.S.; FDA Approves MRI Labeling On BoSci's High-Voltage Devices 9/25/2017

    Boston Scientific (NYSE: BSX) has launched the Resonate™ family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems featuring the HeartLogic™ Heart Failure Diagnostic to help physicians improve heart failure (HF) management.

  8. Medtronic's Next-Gen SCS For Chronic Pain Management Approved By FDA 9/18/2017

    Medtronic plc recently announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain.

  9. NuVasive's MAGEC Scoliosis Treatment Cleared By FDA 9/6/2017

    NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Company's redesigned MAGEC® system with its RELINE® Small Stature system.

  10. Medtronic's Attain Stability Quad MRI SureScan Active-Fixation Heart Lead Gains CE Mark 8/21/2017

    Medtronic plc announced it has received CE (Conformité Européene) Mark for the Attain Stability Quad MRI SureScan left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead features novel, active-fixation technology that is designed for precise lead placement and stability.