Posts by rw-admin
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 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…
Read MoreFDA 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 actually proposing it, as pressure mounted from lawmakers in recent months to follow through on…
Read MoreAltair 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 a chest-worn wireless sensor that accurately detects when someone is suffering Opioid Indused Respiratory Depression…
Read MoreXaTek’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. The FDA Breakthrough Devices Program was created in 2018 to expedite the development, assessment and…
Read MoreNanox Signs Agreement With The Gateway Group for the Deployment of 1,000 Nanox.ARC Units Across Australia, New Zealand, and Norway
NANO-X IMAGING LTD (www.nanox.vision) (“Nanox” or the “Company”), an innovative medical imaging technology company, announces it has secured an exclusive distribution deal with The Gateway Group (“Gateway”), one of Australia’s largest independent product distributors including health, wellness, medical supplies and devices. The agreement has an initial term of three years and is renewable for an additional term of…
Read MoreBaxter Launches Peri-Strips Dry With Secure Grip Technology for Reliable Staple Line Reinforcement in Surgical Procedures
Baxter International Inc., a global leader in advancing surgical innovation, announced 510(k) clearance from the U.S. Food and Drug Administration for a new generation of its Peri-Strips Dry with Veritas Collagen Matrix (PSDV) product, known as PSDV with Secure Grip. Now available with “peel and secure” technology, PSDV is a staple line reinforcement material that bariatric surgeons have…
Read MoreU.S. FDA Grants PAVmed Subsidiary, Lucid Diagnostics, Breakthrough Device Designation for its EsoGuard Esophageal DNA Test
PAVmed Inc., a highly differentiated, multiproduct medical device company, today announced that the Company’s majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its EsoGuard™ Esophageal DNA Test on esophageal samples collected using its EsoCheck™ Cell Collection Device in a prevalent well-defined group…
Read MoreArizona Startup Emagine Solutions Technology Receives FDA 510(k) Clearance of its VistaScan Mobile Ultrasound
Emagine Solutions Technology, an award-winning medical software device company located in Tucson, announced that it has received clearance from the U.S. Food & Drug Administration (“FDA”) to market its VistaScan mobile ultrasound platform. The VistaScan platform transforms a clinician’s cell phone or tablet into a portable ultrasound solution. The system consists of compatible FDA cleared ultrasound probes…
Read MoreEndotronix Announces Enrollment of the First Patients in the PROACTIVE-HF Pivotal Trial
Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Pressure Sensor…
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