Posts by cstephenson@legacymedsearch.com
TriGUARD 3 Cerebral Embolic Protection Device Receives CE Mark for Use in Transcatheter Heart Procedures
Keystone Heart Ltd., a Venus Medtech Company, today announced European CE Mark for the TriGUARD 3™ Cerebral Embolic Protection (CEP) Device. The device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during Transcatheter Aortic Valve Implantation (TAVI) and other transcatheter heart procedures. “Even with increased operator experience…
Read MoreFDA Clears Fluidda’s Broncholab Platform for Use in Clinical Practice
The US Food and Drug Administration provided market clearance to Fluidda for its Broncholab platform. Broncholab provides a number of Functional Respiratory Imaging (FRI) parameters to physicians via an online platform to assist in diagnosing and monitoring of respiratory diseases. The severity of respiratory diseases is often underestimated by conventional lung function tests, such as…
Read MoreOSSIO Receives FDA 510(k) Clearance for OSSIOfiber Hammertoe Fixation System
OSSIO, Inc., an orthopedic fixation company, today announced that its OSSIOfiber® Hammertoe Fixation System has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts. These novel bio-integrative implants with disposable, sterile instrumentation now come in three sizes, with…
Read MoreCryoLife Receives CE Mark for E-vita OPEN NEO
CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has received CE Mark for the E-vita Open NEO, a hybrid stent graft system for the treatment of aortic arch disease. Aortic arch disease includes both aortic aneurysms and aortic dissections, which occur suddenly and usually without warning. Approximately…
Read MoreNeuroPace RNS System Receives FDA Approval for MRI Labeling, Allowing Thousands More Patients to Benefit from Personalized, Data-Driven Epilepsy Treatment
NeuroPace, Inc., a Silicon Valley-based medical technology company, today announced that its RNS® System has received U.S. Food and Drug Administration (FDA) approval of MRI labeling for the RNS System, expanding treatment options for the approximately one million patients in the United States living with seizures that do not respond to medication. Individuals with focal onset…
Read MoreHologic Receives CE Mark for Three-in-One Omni Hysteroscope in Europe
Hologic, Inc. (Nasdaq: HOLX) announced today that it has received a CE mark in Europe for its Omni™ hysteroscope, an innovative three-in-one modular scope with advanced visualization capabilities designed for both diagnostic and therapeutic hysteroscopic procedures. Obstetricians and gynecologists (ObGyns) can use the new Omni hysteroscope in out- and in-patient settings. “Experts agree that direct visualization…
Read MoreTriMed, Inc. Announces Release of the ASET™ Foot Plating Systems
TriMed, Inc. an orthopaedic medical device developer and manufacturer focused on extremities, announced it would begin marketing its new ASET™ Foot Plating System. The ASET Foot Plating System, designed to treat common forefoot and mid-foot indications, offers unique implants to treat MTP fusions, Lapidus fusions, and TMT fusions. In addition, the system’s variety of patented…
Read MoreAerin Medical Announces FDA Clearance and U.S. Launch of Innovative Nonsurgical Procedure for Chronic Rhinitis
Aerin Medical Inc., a company focused on minimally invasive solutions for chronic nasal conditions, today announced U.S. Food and Drug Administration (FDA) clearance and U.S. launch of the company’s second product, the RhinAer™ Stylus, an innovative device for nonsurgical treatment of chronic rhinitis. More than 30 million Americans suffer from nonallergic rhinitis.1 Patients with the condition…
Read MoreHIMSS Announces Cancellation of the 2020 Global Health Conference & Exhibition
Today, following recent reports from the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), HIMSS announced it is clearly necessary to cancel the 2020 HIMSS Global Health Conference & Exhibition. “We recognize all the hard work that so many have put into preparing for their presentations and panels that accompany every HIMSS conference,” said Hal Wolf,…
Read MoreCardiovalve Wins FDA Breakthrough Device Designation for Transcatheter Tricuspid Valve Replacement System
Cardiovalve announced that it has received U.S. Food and Drug Administration (FDA) approval for an Early Feasibility Study (EFS) of its Transcatheter Tricuspid Valve Replacement System for a tricuspid regurgitation (TR) indication. The Cardiovalve System also has been granted ‘Breakthrough Device Designation’ status by the FDA. Cardiovalve is the first privately held company to have…
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