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NeuroPace 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...

March 11, 2020

Diagnostics & Healthcare News

Hologic 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...

March 10, 2020

Orthopedics and Spine

TriMed, 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...

March 10, 2020

Surgery and Surgical Robotics

Aerin 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...

March 9, 2020

Diagnostics & Healthcare News

HIMSS 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...

March 5, 2020

Cardiovascular / Cardiology

Cardiovalve 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...

March 5, 2020

Diagnostics & Healthcare News

FDA Bans Certain Electrical Stimulation Devices, the Third Ban in History

FDA has officially banned electrical stimulation devices used to treat self-injury or aggressive behavior with publication of a final rule Wednesday. The action comes almost six years after convening an advisory committee to weigh the ban and four years after...

March 4, 2020

Diagnostics & Healthcare News

Altair Medical Awarded FDA Breakthrough Device Status to Address the Global Opioid Crisis

Altair Medical, a medical technology company developing a groundbreaking solution to the global opioid crisis, today announce that the US Food and Drug Administration (FDA) has awarded the Company Breakthrough Device designation for its RESPMETERTM wearable biosensor device. Altair Medical’s RESPMETERTM is...

March 4, 2020

Diagnostics & Healthcare News

XaTek’s ClotChip Earns FDA’s Breakthrough Device Designation

XaTek Inc. today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development ClotChip, marking a significant and distinguishing step in advancing the company’s life-changing portable blood-clotting sensor toward commercialization....

March 3, 2020