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Cardiovascular
Acutus Medical Launches AcQCross Transseptal System in Europe
The product is designed to improve safety and efficiency in any procedure requiring left heart access.Globe Newswire 01.08.21
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Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe
Gold-tipped force sensing ablation catheter earns CE Mark.Globe Newswire 01.06.21
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Packaging & Sterilization
Ensuring Labeling Compliance Within European Markets
Upcoming EU Medical Device Regulations will mean a shift to digital processes.Online Exclusives Bob Tilling, VP Global Sales, Kallik 11.13.20
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Diagnostics
Hologic Launches 3DQuorum Imaging Tech, Powered by Genius AI, in Europe
Designed to help improve mammography efficiency and workflow.Business Wire 10.26.20
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Cardiovascular
Endologix Launches ALTO Abdominal Stent Graft System in Europe
First European commercial case completed at a hospital in England.Business Wire 10.15.20
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Neurological
Boston Scientific Launches Spinal Cord Stimulator Systems in Europe
Portfolio features full-body MRI conditional devices that combine therapy options for personalized pain relief.PRNewswire 10.01.20
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Diagnostics
BD's SARS-CoV-2 Antigen Test OKed in Europe
Portable, rapid PoC antigen test to detect SARS-CoV-2 in 15 minutes to be available in Europe by end of October.PR Newswire 09.30.20
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Cardiovascular
Boston Scientific Rolls Out ACCURATE neo2 in Europe
New Valve designed to reduce paravalvular leaking, improve procedural efficiency, and treat more patients with expanded indication over prior version.PRNewswire 09.28.20
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LivaNova Launches Perceval Plus Aortic Heart Valve in Europe
The next-generation sutureless surgical technology is based on a clinically proven platform and designed for valve durability.Business Wire 09.16.20
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Neurological
Boston Scientific Launches Vercise Genus DBS System In Europe
Features full-body MRI conditional and Bluetooth capabilities across the portfolio.PR Newswire 09.10.20
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Baxter Nabs European, Australian Approval for Evo IQ Syringe Infusion System
New addition to Baxter’s Evo IQ Infusion Platform complements on-market large volumetric pump.Business Wire 07.22.20
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Diagnostics
EKF, Tosoh Europe N.V. Distribution Agreement Expands HbA1c Testing
Three-year agreement will expand the reach of EKF's Quo-Test HbA1c point-of-care (POC) analyzer in the Middle East and Africa.EKF Diagnostics 07.15.20
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Molding
Technimark Buys European Injection Molder Tool & Plastic Industries
Acquiring injection molded product supplier expands global manufacturing platform and healthcare focus.PR Newswire 07.15.20
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Senseonics Eversense Sensor Receives MRI Conditional Approval in Europe
Eversense users who need to have an MRI do not need to remove the Eversense XL Sensor.Business Wire 06.25.20
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How Are MPO’s Top 30 Addressing COVID-19?
J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.Online Exclusives Sam Brusco, Associate Editor 06.09.20
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ERA-EDTA Launches European Database of Dialysis Data
New registry initiative collects data of dialysis patients and transplanted patients with COVID-19 in order to measure outcomes and define risk factors.Presswire 06.08.20
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Diagnostics
BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test
Adds automated extraction methods and additional PCR systems.PR Newswire 04.27.20
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MDR Delay Official; Industry Urges Push Back of IVDR
European Council voted 27-0 to adopt amendment delaying MDR application by one year due to COVID-19 pandemic.MedTech Europe 04.24.20
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Diagnostics
Vela Diagnostics' COVID-19 Detection Test Earns CE Mark
Vela Diagnostics has also developed an automated version of the test slated for CE-IVD registration this month.PR Newswire 04.24.20
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FDA OKs Baxter's Oxiris Blood Purification Filter for COVID-19 Treatment
Only filter set available in the U.S. to reduce pro-inflammatory cytokine levels in the blood.Baxter 04.24.20
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Medtronic Sees Revenue Losses Due to COVID-19 Pandemic
The company says it is well positioned for recovery.Globe Newswire 04.22.20
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Integrity Applications Closes $15 Million Private Placement
Shares were sold for 40 cents each.Globe Newswire 04.22.20
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Fist Assist Announces CE Mark and European Launch
Regulatory milestone allows company to expand its commercialization efforts beyond India and into Europe.Business Wire 04.21.20
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Terumo's Mirasol Shows Efficacy Against Virus Causing COVID-19 in Plasma, Platelets
The pathogen reduction system is designed to add an extra layer of safety to the blood supply.Terumo BCT 04.20.20
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Cardiovascular
Endospan's Aortic Arch Stent Graft Earns Breakthrough Status
Addresses significant unmet clinical need for difficult-to-treat aortic arch anatomy.Business Wire 04.20.20
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Baxter’s Q1 Earnings Forecasted to Increase, GlobalData Says
Job postings triple as demand increases.GlobalData 04.17.20
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Cardiovascular
Transcatheter Tricuspid Valve Replacement System Gains Breakthrough Status
Cardiovalve is first company to receive FDA early feasibility study approval for both tricuspid regurgitation and mitral regurgitation indications.Business Wire 04.17.20
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Non-Invasive Ventilators Offer Life-Saving Treatment for Less Severe COVID-19 Patients
Manufacturers could produce more than 60,000 per week, easing pressure on the system.AdvaMed 04.09.20
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Cardiovascular
Abbott's TriClip Transcatheter Tricuspid Valve Repair Gains CE Mark
The device is delivered to the "forgotten heart valve" through the femoral vein in the leg.Abbott 04.09.20
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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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Software & IT
Seeking Software Partners During a Crisis
The COVID-19 pandemic has caught many unprepared to handle increased challenges, leaving them to find assistance.Online Exclusives Svetlana Anishchenko, Director of Marketing, Auriga Inc. 04.07.20
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Cardiovascular
ExThera’s Blood Filter Treats COVID-19 Patients in Europe
Treatments are expected to begin in the U.S. soon.ExThera Medical 04.06.20
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3D/Additive Manufacturing
Materialise's 3D Printed Oxygen Mask Helps Ventilator Shortage
COVID-19 solution brought to hospitals quickly and in full compliance with safety regulations.Videos Materialise
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Joining the Global Effort to Tackle the Face Mask Shortage
The World Health Organization estimates 89 million medical masks will be required monthly amid the coronavirus outbreak.Emerson 04.06.20
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Diagnostics
FDA OKs Luminex's ARIES SARS-CoV-2 Assay
The system is capable of running up to 144 tests per day, requiring no specialty training.PR Newswire 04.06.20
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Diagnostics
Co-Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Test
Company's technology targets the virus's RdRp gene.PR Newswire 04.06.20
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Diagnostics
Siemens Healthineers Releases Test Kit for Coronavirus COVID-19
Test kit will help detect SARS-CoV-2, the cause of COVID-19; company is pursuing EUAs from WHO and FDA for clinical use.Siemens Healthineers 04.02.20
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Tubing & Extrusion
Pathways to Care: Tubing Technologies
Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially.Mark Crawford, Contributing Writer 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
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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FDA Grants Lucid Diagnostics Breakthrough Device Designation for Esophageal DNA Test
Test is designed to facilitate the diagnosis of Barrett’s Esophagus, with and without dysplasia.Globe Newswire 03.30.20
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Diagnostics
FDA OKs Luminex's NxTAG CoV Extended Panel to Detect SARS-CoV-2
BARDA award for $642K helped Luminex accelerate development and validation.PR Newswire 03.30.20
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Diagnostics
Thermo Fisher's COVID-19 Diagnostic Test Gains CE Mark
Test will now be available for qualified laboratories across the European Union.PR Newswire 03.26.20
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Hillrom More than Doubles Critical Care Product Production
Includes ventilators, hospital beds, and vitals monitoring devices to support COVID-19 response.PR Newswire 03.25.20
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Philips Accelerates Production of Critical Health Technology to Fight COVID-19
Company is increasing production of hospital ventilators and plans to double production within eight weeks as well as achieve a four-fold increase by Q3.Royal Philips 03.23.20
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3M Actions to Support Healthcare to Combat COVID-19
Company has doubled global N95 respirator output over last two months.3M 03.20.20
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Paragonix Reports First Successful Use of its SherpaPak Cardiac Transport System
Product is the only FDA-cleared and CE-marked device that safeguards hearts between donor and recipient patients.Business Wire 03.17.20
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Poll: Brexit is Strongly Negative for Medtech Industry
About 18 percent believe the move will benefit the industry.GlobalData 03.16.20
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Baxter, Spectral Medical Reach Agreement for Blood Filter Distribution
Deal enables Baxter to expand its Acute Therapies portfolio to address unmet needs, and gives Spectral Medical a strategic commercialization partner.Business Wire 03.13.20
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Alcon Launches Vivity Presbyopia-Correcting IOL in Europe
Non-diffractive lens offers a continuous extended range of vision.Business Wire 03.12.20
