Regulatory News

  1. FDA Clears Abbott's TactiCath Contact Force Ablation Catheter 1/21/2019

    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).

  2. FDA Clears Verily Study Watch For ECG 1/18/2019

    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.

  3. Medtronic Launches Mobile App That Communicates Directly With Smartphone-Connected Pacemakers 1/15/2019

    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.

  4. FDA Clears First Device To Treat Babies With A Hole In Their Heart 1/14/2019

    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.

  5. TELA Bio, Aroa Biosurgery, Gain FDA Clearance For Large Sizes Of Their Reinforced BioScaffolds 1/10/2019

    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.

  6. AWAK Technologies' Wearable Peritoneal Dialysis Device Gains FDA Breakthrough Device Designation 1/8/2019

    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.

  7. FDA Grants Breakthrough Device Designation To ArcherDX's Companion Diagnostic Assay For Liquid Biopsy, Tissue Specimens) 1/8/2019

    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.

  8. FDA Clears Empatica's Seizure-Monitoring Watch For Pediatric Epilepsy Patients 1/8/2019

    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.

  9. FDA Clears Grifols' Automated Benchtop Analyzer 1/8/2019

    Grifols, a leading producer of plasma- derived medicines and recognized leader in transfusion medicine, has received U.S. Food and Drug Administration approval of Erytra Eflexis, a fully automated, benchtop analyzer.

  10. Novel Intrasaccular Aneurysm Treatment Device Receives FDA PMA Approval 1/7/2019

    MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Premarket Approval (PMA) for the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms.