Latest Headlines

  1. CardioFocus’ HeartLight Excalibur Balloon For AF Treatment Earns CE Mark

    CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF).

  2. Phillips-Medisize Announces FDA Approval Of myBETApp And BETACONNECT Navigator

    Phillips-Medisize, LLC (Phillips-Medisize) is honored to announce Bayer’s recent approval from the U.S. Food and Drug Administration (FDA) for the myBETAapp™ and BETACONNECT™ Navigator. Phillips-Medisize designed and developed the BETACONNECT autoinjector, myBETAapp and the BETACONNECT Navigator via its Medicom device strategy and design services group.

  3. Scientists Create Most Powerful Micro-Scale Bio-Solar Cell Yet

    Researchers at Binghamton University, State University of New York have created a micro-scale biological solar cell that generates a higher power density for longer than any existing cell of its kind.

  4. FDA Approves LivaNova’s SenTiva Device and Next-Gen VNS Therapy Programming System

    LivaNova PLC (“LivaNova” or the “Company”), a market-leading medical technology company, recently announced it received U.S. Food and Drug Administration (“FDA”) approvals for its latest Vagus Nerve Stimulation Therapy (“VNS Therapy”) System, which consists of the SenTiva implantable generator and the next-generation VNS Therapy Programming System for the treatment of patients with drug-resistant epilepsy.

  5. FDA Clears Game Ready’s Multi-Modality Recovery Device

    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™.

  6. FDA Approves Implantable To Treat Central Sleep Apnea

    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.

  7. FDA Clears K2M’s YUKON OCT Spinal System

    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.

  8. Subchondral Solutions’ Screw System For Osteochondral Joint Fractures Cleared By FDA

    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.

  9. FDA Approves Medtronic’s HeartWare HVAD System For Destination Therapy

    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.

  10. Abbott’s FreeStyle Libre Flash Glucose Monitoring System Approved By FDA

    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.