Posts by cstephenson@legacymedsearch.com
Abbott Receives FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity i System
Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT® and Alinity i™ platforms and will have capacity for 60 million tests in…
Read MoreFDA Issues Emergency Use Authorization for Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure During COVID-19 Pandemic
Eko, a digital health company building AI-powered screening and telehealth solutions to fight cardiovascular disease, today announced that the U.S. Food and Drug Administration (FDA) has issued the company an Emergency Use Authorization (EUA) for its novel ECG-based algorithm that can provide an easily accessible, rapid screening test for low ejection fraction (low EF), a weak heart…
Read MoreAmbu Launches New Single-Use Cystoscope for Improved Workflow and Enhanced Productivity Benefits
Ambu Inc., a rapidly growing medical device maker and pioneer of sterile, single-use endoscopes, introduced today a new single-use cystoscope. The Ambu® aScope™ 4 Cysto will give urologists immediate access to a single-use cystoscope that can be used for procedures such as bladder cancer surveillance, stent removal and other common cystoscopy procedures. Built on more…
Read MoreCardioFocus Announces US FDA Approval of HeartLight X3 System for the Treatment of Atrial Fibrillation
CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the next-generation HeartLight® X3 Endoscopic Ablation System for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Approval of the HeartLight X3 System came as a result of a comprehensive submission, including outcomes from the study of 60 HeartLight X3 patients. In…
Read MoreCleanbox Technology to Help Combat COVID-19 PPE Shortage by Allowing Safe Reuse of N95 Masks
Smart tech hygiene company Cleanbox Technology, Inc. has announced a new product, the CleanDefense™, a point-of-use mask decontamination product in response to SARS CoV-2 (COVID-19). Cleanbox’s patented technology uses UVC light in an LED to decontaminate hard-to-clean products worn on the face or head. With a focus on high risk contagion transfer points, its core products were designed…
Read MoreFDA Approves Aspenstate’s AiRTouch Portable X-Ray System for Human Medical Use
Aspenstate has received clearance for their portable x-ray system, AiRTouch, from the U.S. Food and Drug Administration (FDA). Amongst many applications, this device is a simple and efficient front-line tool to acquire chest x-rays to diagnose COVID-19. The AiRTouch device offers a unique list of capabilities in the battle against COVID-19. It’s lightweight (5.5 lbs),…
Read More3M Awarded Department of Defense Contracts to Further Expand U.S. Production of N95 Respirators
3M has been awarded two contracts through the U.S. Department of Defense in recent weeks to further expand U.S. production of N95 respirators in response to the COVID-19 outbreak. Beginning in January, 3M ramped up production of respirators and doubled its global output to 1.1 billion per year – including 35 million N95 respirators per…
Read MoreZOLL TherOx Receives CE Mark Approval for Supersaturated Oxygen Therapy
ZOLL Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today it has received CE Mark approval to market and distribute its SuperSaturated Oxygen (SSO2) Therapy System in Europe. SSO2 Therapy provides interventional cardiologists with the first and only clinically proven treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage…
Read MorePulmonx Secures $66M in Financing to Support Commercial Acceleration of the Zephyr Valve System, a Minimally-Invasive Treatment for Severe Emphysema
Pulmonx Corporation, a commercial-stage medical technology company that provides a minimally-invasive treatment for patients with severe emphysema, announces a $66 million financing led by Ally Bridge Group, a leading global life science investor. The financing also attracted new investors Adage Capital Management, HealthQuest Capital, Partner Fund Management, and Rock Springs Capital, as well as existing…
Read MoreTruMed Systems, Inc. Announces Launch of the AccuShelf Total Practice Inventory Management System, to Complement the AccuVax Vaccine Storage and Handling Solution
AccuShelf makes inventory control simple, from tracking of receiving items, to patient administration. The system utilizes an all-in-one touch screen PC system with an integrated biometric reader and a wireless barcode scanner to capture and record every medication dose with lot, and expiration. It tracks each dose to a specific patient and can communicate with…
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