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Cardiovascular
FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump
Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.Michael Barbella, Managing Editor 02.25.21
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New Home Use Indication Granted for the Passio Pump Drainage System
Product is designed for the drainage of recurrent and symptomatic pleural effusion.PR Newswire 12.15.20
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Cardiovascular
Improved Outcomes Seen in More Complete Revascularization Using Impella Heart Pumps
Impella use led to a 29 percent reduction in MACCE at 90 days.Business Wire 11.30.20
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FDA Clears Bearpac Medical's New Passio Pump Drainage System
The Class II electronic handheld pump gives clinicians a more controlled delivery of therapy for patients experiencing pleural effusions.PR Newswire 10.09.20
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Cardiovascular
Large Japanese Study Finds High Survival Rates With Impella Heart Pump Use
Data show that Impella therapy is an effective treatment for fulminant myocarditis, with an 88 percent survival rate at 30 days.Business Wire 09.23.20
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BD Recalls Alaris Infusion Pumps Over Stuck, Unresponsive Keys
Could lead to an infusion delay or prevent clinicians from changing fluid or medication infusions.U.S. Food and Drug Administration 09.15.20
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Chronic Disease
FDA Approves Medtronic's MiniMed 770G Insulin Pump System
New smartphone-connected hybrid closed-loop system will be available to individuals as young as two.PR Newswire 09.02.20
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Expanded Pediatric Indication for Tandem Diabetes' t:slim X2 Insulin Pump
Product's Control-IQ technology requires no fingersticks for calibration or diabetes treatment decisions.Business Wire 08.11.20
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Cardiovascular
Abiomed's Impella Heart Pump Gains EUA for Unloading Therapy for COVID-19 Patients
COVID-19 causes widespread inflammation which can result in damage to the lungs and heart.Business Wire 08.04.20
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IRADIMED Issued Patent for Infusion Pump Remote Control
Latest patent expands previous claims around IRADIMED’s wireless communication.Globe Newswire 07.13.20
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Chronic Disease
Tandem Diabetes Earns Expanded Pediatric Indication for Insulin Pump
t:slim X2 insulin pump with Control-IQ technology now available to children age six and older.Business Wire 06.18.20
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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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Cardiovascular
FDA Approves First-in-Human Trial of Abiomed's Impella ECP Heart Pump
Company claims Impella ECP is the world’s smallest heart pump.Business Wire 06.05.20
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Solid Growth Expected for Asian Insulin Pumps and CGM Market
Sector forecast to be worth more than $1 billion by 2028.GlobalData 06.02.20
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Cardiovascular
Medtronic Recalls HeartWare HVAD Pump Outflow Graft, Strain Relief
Outflow graft of the HVAD Pump may tear and the strain relief screw may break during assembly.U.S. Food and Drug Administration 05.29.20
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Chronic Disease
Medtronic Donates $1 Million in Insulin Pump Parts to Insulin for Life
Supports continuity of pump therapy for diabetic patients experiencing financial hardships due to COVID-19.GlobeNewswire 05.01.20
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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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Dexcom and DreMed Diabetes Forge Data Partnership Agreement
Collaboration enables Dexcom CGM users in the U.S. to seamlessly use DreaMed’s Advisor Pro platform for optimal patient insulin therapy management.Business Wire 04.16.20
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FDA OKs B. Braun Infusion Pumps with Nebulizers to Treat COVID-19
Pumps to be used for tracheal delivery of continuous nebulized medications into a nebulizer.PR Newswire 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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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
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
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Former Boston Scientific Marketing Director Joins CorWave Board
New board member also worked for Medtronic and Avedro.Business Wire 04.01.20
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Cardiovascular
Ancora Heart Expands U.S. Early Feasibility Study
CorCinch HFrEF study is evaluating the safety of AccuCinch Ventricular Repair System in heart failure patients.Business Wire 03.12.20
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BD Recalls Alaris System Infusion Pumps
Multiple system errors, software errors, and use-related errors have occurred; one death reported.U.S. Food and Drug Administration 03.06.20
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Contract Manufacturing
The Seychelles—A Solution for Niche Production
Geographic location, free trade agreements, and an educated workforce make the location an excellent fit for the right manufacturer.Jude Shroff, Managing Director, Chelle Medical Ltd. 03.04.20
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Cardiovascular
BioVentrix Granted CE Mark Extension for Revivent TC System
Company received initial CE Mark for the product four years ago.Business Wire 03.03.20
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Chronic Disease
Tandem's Basal-IQ Gains FDA Clearance as iAGC
This is the second system to receive interoperable automated glycemic controller designation by the FDA.Tandem Diabetes Care 03.02.20
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Neurological
FDA OKs Flowonix's Prometra II Pump with Intrathecal Baclofen
Expands market for the device by enabling use in spasticity treatment.PR Newswire 02.20.20
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Former Cantel Medical CEO to Take Helm at Ivenix
New chief executive has more than 25 years of global healthcare experience.Business Wire 02.20.20
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Chronic Disease
Abbott, Insulet Partner on Automated Insulin Delivery System
Combining Abbott's glucose sensing technology with Insulet's next-generation tubeless system.Abbott Laboratories 02.19.20
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Cardiovascular
Abbott Wins EU Approval for Next-Gen Gallant ICDs, CRT-Ds
Smartphone app and Bluetooth connectivity helps doctors tailor therapy to a patient's clinical needs.Abbott Laboratories 02.18.20
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Former Qualcomm Executive to Direct Corporate Strategy at Tandem Diabetes
New hire spent 11 years at the telecommunications equipment firm.Business Wire 02.14.20
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Chronic Disease
Medtronic Recalls MiniMed Insulin Pumps
Incorrect insulin dosing has so far resulted in 2,175 injuries and 1 death.U.S. Food and Drug Administration 02.12.20
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Striving Toward a Cool, Healthy Future
University of Missouri engineers design on-skin electronic device that doubles as a personal air conditioner and health monitor.University of Missouri 02.11.20
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IRRAS Receives Renewed CE Mark for IRRAflow Catheter
Product combines controlled irrigation with ongoing fluid drainage to better manage patients with intracranial bleeding.PR Newswire 02.05.20
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Cardiovascular
Abbott's Implantable Heart Pump Earns FDA's Breakthrough Device Designation
Designation awarded for the company's Fully Implantable Left Ventricular Assist System (FILVAS).02.04.20
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Cardiovascular | Digital Health
ECG-Based Algorithm for Detecting Heart Failure Wins Breakthrough Status
Developed in collaboration with Mayo Clinic, Eko's algorithm would help detect an ailing heart during a standard physical exam.Globe Newswire 02.04.20
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Cardiovascular
Is a Cardiac Pump the Key to Curbing Heart Failure?
Large clinical trial to determine whether treatment change for heart attack patients can help prevent future deaths.Videos Business Wire
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FDA Clears t:slim X2 Insulin Pump With Advanced Hybrid Closed-Loop Technology
Automated insulin dosing software is the first to receive new classification by the agency.Business Wire 02.03.20
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Study Reveals Durability of Weldable TPE Tubing
Single-use TPE tubing lasts up to 2.5 times longer in extended production in peristaltic applications.Watson-Marlow Fluid Technology Group 01.30.20
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Impulse Dynamics Secures $80.25 Million Financing
Funding to accelerate the commercialization of the Optimizer Smart System for heart failure.Business Wire 01.24.20
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Software & IT
Medtronic Launches SynchroMed II Pump Data Management Software
Efficio software provides enhanced, secure patient data access and delivers actionable insights in a secure cloud.GlobeNewswire 01.23.20
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Patient Monitoring
Tandem Diabetes Launches New Version of Insulin Pump in U.S.
It is the first and only system cleared to deliver automatic correction boluses in addition to adjusting insulin.Business Wire 01.16.20
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Health Canada Approves Tandem Diabetes Care's t:slim X2 Insulin Pump
The t:slim X2 pump is up to 38 percent smaller than other pumps yet can hold up to 300 units of insulin.Business Wire 01.14.20
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CES 2020: First Electronic, Personalized Blood Flow Restriction Pump
SmartTools' blood flow restriction cuffs expand beyond the clinical space to reach fitness enthusiasts.GlobeNewswire 01.08.20
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Cardiovascular | Surgical
FDA OKs New Surgical Approach for Abbott's HeartMate 3
Can now be implanted through an incision in the chest wall versus open-heart surgery.PR Newswire 01.07.20
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Patient Monitoring
FDA OKs UVA-Developed 'Artificial Pancreas'
Device automatically regulates blood glucose for type 1 diabetes patients.University of Virginia Health System 01.02.20
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Patient Monitoring | Software & IT
FDA OKs First Interoperable, Automated Insulin Dosing Controller
The technology was designed to allow more choices for patients looking to customize their individual diabetes management device system.U.S. Food and Drug Administration 12.17.19
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Patient Monitoring | Software & IT
Medtronic Buys Klue to Boost Diabetes Management Business
Klue's behavior tracking software can provide real-time insights into when a person is consuming food via gesture sensing and analytics technology.GlobeNewswire 12.17.19
