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Study Results Confirm Safety Profile of Philips Stellarex .035” Low-Dose DCB
Stellarex consistently demonstrates no difference in mortality every year through five years when compared with percutaneous transluminal angioplasty.Royal Philips 06.17.21
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Study Shows High Safety, Efficacy for Adjustable Thrombectomy Device
Data demonstrate 84.6 percent revascularization success with Rapid Medical’s TIGERTRIEVER.Michael Barbella, Managing Editor 05.04.21
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U.S. Safety Needles Drugs Market to Top $ 3.4 Billion By 2027
Product launches for drug delivery is expected to drive market growth.Michael Barbella, Managing Editor 04.08.21
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U.S. Safety Needles Market to Top $3.4B by 2028
Favorable government reimbursement for pen needles is expected to help drive the market.Michael Barbella, Managing Editor 03.19.21
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Study Results Confirm Safety of Philips Stellarex .035-Inch Drug-Coated Balloon
No difference in mortality seen between patients treated with the Stellarex drug-coated balloon and those receiving percutaneous angioplasty.Michael Barbella, Managing Editor 02.03.21
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Study Data Demonstrates Safety of MONARCH Platform
The MONARCH Platform localized targeted nodules using a combination of direct visualization, navigational guidance, and radial endobronchial ultrasound.Michael Barbella, Managing Editor 02.02.21
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Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon
No difference in mortality between patients treated with Philips' Stellarex drug-coated balloon and those treated with percutaneous angioplasty.Royal Philips 12.03.20
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Cardiovascular
Study: Exceptional Safety, Procedural Success With Coronary Orbital Atherectomy
Data show OAS to be safe and successful in streamlining treatment for patients with the most significant coronary disease.Business Wire 11.24.20
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Dental Markets Need Safety Innovations to Accelerate Recovery
Dental devices don’t have the saving grace of being used in any part of the COVID-19 treatment pathway, making recovery from the pandemic a challenge.GlobalData 10.01.20
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AdvaMed Launches Responsible Advertising for Patient Safety Website
Aims to drive and enhance awareness of the dangers of misleading ads for medtech litigation.AdvaMed 09.23.20
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Patient Monitoring
Masimo Expands the Masimo SafetyNet Remote Patient Management Solution
The Radius Tº Wearable Temperature Sensor automates remote monitoring of patient temperature status.Business Wire 09.21.20
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Electronics
Designing for Safety with Specialist Resistors
How resistors for high voltage and surge medical applications reduce risk in the new ‘healthcare anywhere’ scenario.Online Exclusives Stephen Oxley, Business Development Engineer, TT Electronics 09.14.20
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Cardiovascular
Data Reconfirms Long-Term Safety of Philips Stellarex Low-Dose Drug-Coated Balloon
The mortality rate at four years shows no statistical difference between two patient groups.Royal Philips 08.27.20
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Study Confirms Safety, Durability of PROCEPT BioRobotics’ Aquablation Therapy
Two-year follow-up data confirmed that Aquablation is a safe procedure with durable efficacy.Business Wire 07.27.20
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Cardiovascular
Study Affirms Safety of Two-Lead Optimizer System
The two-lead device represents a significant advancement in the development of cardiac contractility modulation therapy for heart failure patients.Business Wire 06.10.20
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Patent for AI-powered Medical Device Safety Monitoring Granted in Indonesia
The patent ensures rights to a system that enables AI-powered supervision of the functionality of mobile medical equipment with injection apparatus.news.cision.com 05.28.20
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Advancing Infection Prevention Tools
The applications and benefits of porous polymer materials and components.Jack Chan, Global Marketing Director, Porex
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Surgical
FDA Update on Essure Postmarket Activities
All unused Essure devices of which Bayer is aware have been returned to the company.U.S. Food and Drug Administration 04.27.20
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Sporting Goods Brand Now Making Millions Of Face Masks
Company will donate face masks to those in need including hospice workers, nursing homes, assisted living facilities, and first responders.StringKing 04.27.20
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Diagnostics
Enzo Biochem Launches COVID-19 Diagnostic Test
Proprietary molecular diagnostic kits offer improved scale, throughput, and sensitivity.Business Wire 04.23.20
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Diversified Plastics Increases Capacity of Acceleration Station to Meet Manufacturing Demand
The Station’s engineering and production teams work closely with customers to save time and money by optimizing parts for digital manufacturing.Diversified Plastics Inc. 04.23.20
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The Medtech Supply Chain and COVID-19
How are service providers and component suppliers adjusting to life during a pandemic to ensure they maintain quality?Online Exclusives Sean Fenske, Editor-in-Chief 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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EarlySense Names New Senior Vice President of Strategic Partnerships
Former Cerner and Allscripts executive joins company to deepen existing relationships and broaden new global opportunities.EarlySense 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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Molding
Mack Molding, Health System Partner to Develop Face Mask Alternative
Within two weeks, the team fabricated an attachment to a snorkeling scuba mask.Mack Molding 04.22.20
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Diagnostics
FDA OKs LabCorp's At-Home COVID-19 Test Kit
Permits testing of a sample collected from the patient’s nose using a designated self-collection kit.U.S. Food and Drug Administration 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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Surgical | Testing
Medical Robots: Assessing Safety and Performance in a Growing Field
Be aware of potential hazards robots may present and testing options to address them.Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 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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AptarGroup Seeking Emergency Authorization for Easy Mask Disinfection Process
Process takes three hours and can be performed on-site at hospitals.AptarGroup Inc. 04.17.20
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Molding
Vaupell Midwest Earns MedAccred Accreditation for Plastic Injection Molding
MedAccred is an oversight program designed to provide manufacturing supply-chain oversight for OEMs looking to partner with Contract Manufacturers.Vaupell Midwest 04.16.20
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3M, Cummins Partner to Boost Powered Air Purifying Respirator Filter Production
The 3M designed filters will be made in Cummins’ Neillsville, Wis. plant.Business Wire 04.15.20
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Contract Manufacturing
Philips Partners with Flex, Jabil to Speed Hospital Ventilator Production
Philips hopes to manufacture 4,000 units per week by the third quarter.Philips 04.14.20
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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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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
Sharp Fluidics Acquires neoClose Laparoscopic, Robotic Port Closure Technology
neoClose utilizes bio-absorbable anchors with a pre-attached suture.PR Newswire 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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Pentax Medical to Pay $43 Million Over Misbranded Endoscopes
Company shipped medical devices without approved instructions for use and failed to file FDA-required adverse event reports of serious infections.U.S. Department of Justice 04.08.20
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Zimmer Biomet CEO Foregoing Salary During COVID-19 Crisis
Bryan Hanson's salary forfeit is among many steps the company is taking to contain costs amid the pandemic.Zimmer Biomet 04.07.20
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SynDaver Manufactures Respirators to Help with Shortage
The manufacturing process begins April 7.SynDaver 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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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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MIT Begins Mass Manufacture of Disposable Face Shields
A team from MIT has designed disposable face shields that can be mass-produced.Videos Mary Beth Gallagher, Department of Mechanical Engineering, Massachusetts Institute of Technology
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Diagnostics
COVID-19 Patients Being Triaged, Assessed Using Two-Minute Breath-Based Gas Test
The MediPines AGM100's breathing gas-based measurement can provide immediate respiratory data after the patient breathes into a breathing tube.PR Newswire 04.06.20
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Adopted Proposal Would Delay MDR One Year
The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.European Commission 04.03.20
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Diagnostics
COVID-19 At-Home Test Ready for Validation Study
Care Access Research will lead clinical trials of the coronavirus test.Care Access Research 04.03.20
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Cardiovascular
VADovations Secures Investment, Development Agreement for Percutaneous Endovascular Delivery System
Product is designed to avoid open surgical implantation while addressing the limitations of current blood pumps.Business Wire 04.03.20
