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Eitan Medical Receives FDA Clearance for Sapphire Infusion System
Upgraded infusion system provides advanced performance and customization capabilities within hospital, pre-hospital and ambulatory environments.Eitan Medical 01.20.21
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AtriCure Receives FDA Clearance to Expand its Labeling for Cryo Nerve Block Therapy
The expansion includes adolescent patients who can benefit from cryo nerve block therapy during surgical procedures involving the chest wall.Business Wire 01.20.21
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Neurological
BioSerenity Achieves FDA Clearance for Wearable Device System
Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.PRNewswire 01.07.21
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keepMED Raises Funding for Regulatory Clearance of its Sleep Apnea Device
Company's technology mobilizes the user’s respiratory system to deliver just the amount of PAP needed, intermittently and with minimal airflow.Business Wire 11.04.20
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Hyperfine Research Receives FDA Clearance for Swoop Portable MRI System
Technology defines new product category for accessible, cost-effective point-of-care magnetic resonance imaging.Business Wire 10.05.20
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Digital Health
HD Medical Awarded FDA Clearance for HD Steth
Intelligent stethoscope with integrated ECG delivers instant cardiac insights.Business Wire 09.11.20
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Rapid ASPECTS Receives CADx Clearance From the FDA
AI-powered stroke imaging solution is the first to receive FDA advanced CADx clearance to raise reading capabilities for non-expert readers.Business Wire 09.08.20
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Venus Concept Wins FDA 510(k) Clearance for Venus Viva MD
The new skin rejuvenation solution with differentiated features allows clinicians to treat a wider range of conditions.Globe Newswire 09.02.20
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Gynesonics Receives FDA Clearance to Market Next-Generation Sonata System 2.1
Early launch in Europe contributes to significant procedural growth.Business Wire 07.29.20
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Beckman Coulter Receives FDA Clearance for Automated Microplate System
Processes up to 300 samples per hour with a maximum of 12 tests per sample.PRNewswire 07.23.20
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Getinge's Servo-air Mechanical Ventilator Receives 510(k) Clearance
Includes both Invasive and Non-Invasive (NIV) ventilation modes.Getinge 07.07.20
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Magnolia Medical Secures FDA Clearance for Expanded Steripath Gen2 Products
Devices become the first and only products indicated to reduce blood culture contamination.PR Newswire 05.14.20
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Mauna Kea's Next-Generation Cellvizio Platform Receives FDA Clearance, CE Marking
The new platform includes significant improvements and will enable major innovations, such as integrating easily with robotic systems.Business Wire 05.13.20
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CHF Solutions Receives FDA Clearance for Aquadex SmartFlow System
The system provides a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload).Globe Newswire 04.30.20
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Kurin Receives FDA 510k Clearance for Its Push-Button Needle
Company's technology automatically and passively sidelines potential contaminants during blood culture collection.Business Wire 04.24.20
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Hologic Executive Joins Alydia Health as Chief Medical Officer
New hire also served as division chief of Obstetrics and Gynecology at Tufts Medical Center.Business Wire 04.23.20
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Diagnostics
FDA Clears Siemens Healthineers' Aidan AI
The latest technology enables new features and enhanced security.Siemens Healthineers 04.22.20
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FDA Clears Bimini Health Tech's Dermapose Refresh Fat Transfer
Dermapose Refresh is an all-in-one microfat transfer system.PR Newswire 04.22.20
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HeartVista Forms Medical and Scientific Advisory Board
Governing body comprised of leaders from Stanford University and the University of Wisconsin.Business Wire 04.16.20
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FDA Clears EndoClot Plus's GI Submucosal Lifting Product
Product targets the rapidly growing U.S. endoscopic submucosal dissection market.Business Wire 04.14.20
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Diagnostics
FDA OKs COVID-19 Saliva Test
Self-collected spit test eliminates risk to those handling the samples.PR Newswire 04.13.20
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Mike on Medtech: COVID-19, Part 2
Mike Drues and Sean Fenske discuss issues involved with misinformation around products to help treat COVID-19 and relaxed regulatory rules.Sean Fenske, Editor-in-Chief 04.08.20
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Surgical
FDA OKs Nitiloop's Microcatheter to Treat Chronic Total Occlusion
Designed solely for antegrade approach, NovaCross is positioned to tap into the $500M CTO market.PR Newswire 04.08.20
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Cardiovascular
BioVentrix Names Co-Principal Investigator for Transcatheter Device Trial
Newly-appointed leader has served as the national or international principal investigator for more than 100 national and international randomized trials.Business Wire 04.08.20
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CloudCath Announces $12 Million Series A Financing
Funds will be used to advance commercialization of technology enabling remote, real-time complication monitoring for at-home dialysis.Business Wire 04.07.20
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PhysIQ Expands Patent Portfolio for Artificial Intelligence Analytics in Wearables
Company receives patent for deep net approach to estimating functional capacity daily from continuous wearable sensor data.PhysIQ 04.07.20
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Surgical
FDA Clears CrossBay Medical's CrossGlide Endometrial Tissue Sampler
Endometrial biopsy procedures can be done gently, effortlessly, and without a tenaculum.Business Wire 04.02.20
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FDA OKs Outset's Table System for Home Dialysis
First new device cleared for home hemodialysis in 15 years.PR Newswire 04.02.20
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Diagnostics
Biomerica Working With N.Y. Medical School on COVID-19 Antibody Test
Once developed and scaled-up, the company’s existing production capacity could allow for more than 1 million tests per month.Globe Newswire 04.02.20
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Virgin Orbit Designs New Mass-Producible Ventilator
Aims to have a functioning, deployable bridge ventilator in production in early April.Virgin Orbit 04.01.20
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R&D & Design
Why Outsourcing Is in: Piecing Out Projects Makes Sense
Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.Dawn A. Lissy, President & Founder, Empirical 04.01.20
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Diagnostics
FDA OKs Sectra's Digital Pathology Module
Available for primary diagnostics and remote reading in the U.S.PR Newswire 04.01.20
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Diagnostics
Cue Health Awarded $13 Million for Rapid, Portable COVID-19 Test
Company's diagnostic can detect virus in less than 25 minutes using a nasal swab.Globe Newswire 03.31.20
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Diagnostics
Siemens Healthineers’ RAPIDPoint 500e Blood Gas Analyzer Cleared
The analyzer is used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room.Siemens Healthineers 03.31.20
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Patient Monitoring
FDA OKs Nuvo's INVU Remote Pregnancy Monitoring
Self-administered, non-invasive remote fetal, maternal heart rate monitoring.PR Newswire 03.31.20
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Neurological
FDA OKs electroCore's gammaCore to Prevent Migraines
Non-invasive vagus nerve stimulation therapy now available for migraine prevention and acute treatment.GlobeNewswire 03.30.20
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Atlantic Therapeutics Receives FDA Clearance for Over-the-Counter Use of INNOVO
Product is now available to order without a prescription for treating bladder weakness in women.Business Wire 03.20.20
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Alydia Health Completes Enrollment in Pivotal PEARLE IDE Study
The investigational Jada System is designed to treat abnormal postpartum uterine bleeding and hemorrhage following childbirth.Business Wire 03.19.20
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Diagnostics
Biomerica Begins Shipping Samples of 10-Minute Test for COVID-19 Exposure
The test for coronavirus exposure uses blood from a finger prick and can be performed anywhere by trained professionals.Globe Newswire 03.18.20
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Diagnostics
FDA OKs AI Image Reconstruction for Canon Medical's 3T MR System
Uses a deep learning algorithm to differentiate true MR signal from noise.Business Wire 03.18.20
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Diagnostics
Survey: Lack of Access to Diagnostic Tests Has Driven Spread of Coronavirus
CDC reports that more than 22,000 specimens or nose swabs have been taken in the U.S. since the outbreak began, far below other developed countries.GlobalData 03.17.20
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Carestream Health Earns 37 U.S. Patents in 2019
Total worldwide patents amounted to 75 last year.Business Wire 03.16.20
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Diagnostics
FDA OKs Meridian Bioscience's Curian Analyzer and HpSA Assay
Curian and Curian HpSA are designed to quickly detect Helicobacter pylori antigens.GlobeNewswire 03.16.20
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Surgical
FDA OKs TransEnterix's Robotic Surgery Machine Vision System
Intelligent surgical unit enables augmented intelligence on the Senhance Surgical System.Business Wire 03.13.20
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Diagnostics | Software & IT
FDA OKs behold.ai’s AI Algorithm for Radiology Triage
Alerts radiologists of a collapsed lung as soon as the X-ray image is captured.GlobeNewswire 03.12.20
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Diagnostics
Coronavirus Detectable With IDbyDNA Explify Respiratory Test
Explify Respiratory is a validated laboratory developed test for respiratory pathogens, including human coronaviruses.Business Wire 03.10.20
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Packaging & Sterilization
FDA Clears 15-Minute Hydrogen Peroxide Sterilization System
Advanced Sterilization Products claims process is 38 percent faster than competitors.Business Wire 03.09.20
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Neurological
Neuronetics' TMS Device for Bipolar Depression Wins Breakthrough Status
Could potentially provide more effective treatment with limited safety concerns.GlobeNewswire 03.06.20
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Cardiovascular | Surgical
FDA OKs Stereotaxis' Genesis Robotic Magnetic Navigation
Robotic navigation of magnetic ablation catheters treats heart rhythm disorders.GlobeNewswire 03.06.20
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Chronic Disease
FDA OKs Aerin's Nonsurgical Chronic Rhinitis Treatment
RhinAer disrupts signals that cause runny nose, post-nasal drip, congestion, and chronic cough.Business Wire 03.05.20
