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.
CorMatrix® Cardiovascular, Inc. www.cormatrix.com, 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.
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).
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.
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.
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.
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.
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.
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.
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.
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