Latest Headlines

  1. Medtronic Acquires Cardiac Ablation System Maker Epix Therapeutics

    Medtronic plc (NYSE: MDT) today announced that it has entered into a definitive agreement to acquire EPIX Therapeutics, Inc. (EPIX), a privately-held medical device company that designs and manufactures a novel, catheter-based, temperature-controlled cardiac ablation system for the treatment of patients with cardiac arrhythmias (irregular heartbeats), including atrial fibrillation (AF). When completed, the EPIX acquisition will expand the Medtronic cardiac ablation portfolio to offer physicians a comprehensive suite of tools to treat patients with cardiac arrhythmias.

  2. FDA Grants IDE Approval To CorMatrix’s Cardiac Valve

    CorMatrix® Cardiovascular, Inc., a leading developer of regenerative cardiovascular medical devices, today announced FDA approval of an early feasibility study IDE to evaluate the safety and feasibility of the Cor™ TRICUSPID ECM® cardiac valve for adults with endocarditis and for pediatric patients with congenital heart valve disease.

  3. FDA Clears Abbott’s TactiCath Contact Force Ablation Catheter

    Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) approval of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™, a new ablation catheter designed to help physicians accurately and effectively treat atrial fibrillation (AFib).

  4. FDA Clears Verily Study Watch For ECG

    In April of 2017, we launched Verily Study Watch, an investigational device for capturing health information from clinical research participants while serving as an easy-to-read watch for daily wear.

  5. Medtronic Launches Mobile App That Communicates Directly With Smartphone-Connected Pacemakers

    Medtronic plc recently announced the launch of its MyCareLink Heart mobile app to support the world's first and only portfolio of pacemakers that can communicate directly with patients' smartphones and tablets.

  6. FDA Clears First Device To Treat Babies With A Hole In Their Heart

    Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolo™ Occluder, the world's first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA.

  7. TELA Bio, Aroa Biosurgery, Gain FDA Clearance For Large Sizes Of Their Reinforced BioScaffolds

    TELA Bio®, Inc. and Aroa Biosurgery, the joint developers of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market large sizes of OviTex RBS.

  8. AWAK Technologies’ Wearable Peritoneal Dialysis Device Gains FDA Breakthrough Device Designation

    AWAK Technologies (AWAK), a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable and ultra-portable PD system that incorporates AWAK’s patented sorbent technology.

  9. FDA Grants Breakthrough Device Designation To ArcherDX's Companion Diagnostic Assay For Liquid Biopsy, Tissue Specimens)

    ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for ArcherDx's companion diagnostic assay application.

  10. FDA Clears Empatica’s Seizure-Monitoring Watch For Pediatric Epilepsy Patients

    Embrace by Empatica has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in children. Embrace is an epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers.