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Mike on Medtech: CDRH 2021 Priorities
Mike Drues and Sean Fenske discuss several of the priorities the agency has been talking about recently and why they are important.Sean Fenske, Editor-in-Chief 01.08.21
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New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System
The results show the device effectively delivers dose volumes up to 5 mL subcutaneously.B3C newswire 01.08.21
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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
Pandemic May Hinder Growth in Peripheral Drug-Coated Balloon Market
Percutaneous transluminal angioplasty balloon procedures declined by almost 30 percent in 2020.GlobalData 12.15.20
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Growing Awareness of Diabetes Management Drives CGM Devices Market
The continuous glucose monitoring devices sector grew robustly in the third quarter.GlobalData 12.10.20
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Home Oxygen Therapy to Drive Oxygen Concentrators Market Growth in India
Last year, portable oxygen concentrators accounted for more than 60 percent of the country's oxygen concentrators market.GlobalData 12.09.20
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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
Draper Develops Noncontact ECG Sensor
Enables direct measurement of the heart’s three-dimensional (3D) bioelectric field.Draper 11.24.20
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Chronic Disease
Varian Invests $10M in COTA to Boost Data-Driven Cancer Care
Companies will work together to empower cancer clinics with data analytics and decision support tools.PR Newswire 11.10.20
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Cardiovascular
FDA Approves Boston Scientific's Ranger Drug-Coated Balloon
Drug-eluting stent and drug-coated balloon treats patients with peripheral artery disease.PR Newswire 11.03.20
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Electronics
Addressing the Non-Magnetic Inductor Need in Medical Electronics
A proprietary non-magnetic material developed by Gowanda Electronics provides inductance qualities.Online Exclusives Michael Barbella 11.03.20
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Global Implantable Drug Delivery Devices Market to Exceed $21.7 Billion by 2027
Growth is attributable to an increasing prevalence of non-communicable diseases, product launches, and acquisitions.Coherent Market Insights 10.30.20
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Cardiovascular
Medtronic, The Foundry to Develop Mitral Valve Repair Technology
Half Moon Medical’s technology now ready for evaluation in early feasibility study.Medtronic plc 10.15.20
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Considerations in Designing 'Fail-Safe' Motor Drive Circuits
Products must be constructed to fail in a safe manner to protect both patients and physicians.Online Exclusives Michael Barbella, Managing Editor 10.15.20
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Increasing Use in Home Care Settings to Drive Pulse Oximeters Growth in India
Last year, table top pulse oximeters accounted for more than 60 percent of the country's pulse oximeters market.GlobalData 10.13.20
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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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Electronics
Connected Health Driving Demand for Comprehensive Electronics Solutions
Medical electronics must be designed to handle the increased bandwidth, high-speed interconnects inclusive of fiber optics, and high signal integrity and speed.Online Exclusives Michael Barbella, Managing Editor 10.09.20
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St. Jude Children's Research Hospital Executive Joins Cardiovascular Systems Board
New member is the third independent director to join the board.Business Wire 10.07.20
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MedCrypt Acquires MedISAO, Addressing FDA Premarket and Postmarket Guidances
The deal establishes the implementation standard for medical device security.PR Newswire 10.06.20
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Contract Manufacturing
Innovation and Expertise Drive Evolution in Medical Device Manufacturing
MICRO’s president offers a look at the company his family founded 75 years ago as well as the industry it’s supported.Online Exclusives Brian Semcer, President, MICRO 09.29.20
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Carestream Introduces New DRX-Compass X-ray System
Versatile, future-proof digital imaging unit scales to meet growing technology needs of customers.Business Wire 09.25.20
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Software & IT
Adopting a Data-Driven Approach to Quality with an MDQMS
FlexLogical is making quality a competitive advantage through its software solution.Online Exclusives Jon Speer, Founder and VP of QA/RA, Greenlight Guru 09.24.20
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Cardiovascular
Medtronic's TYRX Driveline Wrap Device Earns Breakthrough Status
Securely holds a percutaneous driveline in patients receiving a ventricular assist device.Medtronic 09.23.20
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United Health Products Files HemoStyp Hydrocolloid Patents
The latest application relates to methods of forming and using a hemostatic material.Business Wire 09.17.20
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Facts to Ensure MDR Success
Even with the delay of the European Union’s MDR deadline until May 26, 2021, the race to reach compliance is still on for medical device manufacturers.Sherry Parker, Ph.D. and Bob Pryzgoda, Ph.D. 09.01.20
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Cardiovascular | Surgical
Medtronic Cryoablation Outperforms Drug Therapy for Symptomatic Paroxysmal AFib
New research highlights first-line use of cryoablation as highly effective, and with improved quality of life scores.GlobeNewswire 08.31.20
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Masimo Introduces Neurostimulation Device for Opioid Withdrawal Symptoms
Bridge device was found to reduce opioid withdrawal symptoms within 15-30 minutes and provide continuous relief for as long as it was applied.Business Wire 08.28.20
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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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Chronic Disease | Digital Health
Bayer Re-Invests in Digital Health Firm One Drop
Accelerate the development and commercialization of One Drop's digital health platform and data-driven predictive capabilities.PR Newswire 08.26.20
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ERT Continues to Drive Innovation in Virtualization for Respiratory Clinical Trials
Partnership with Inofab Health keeps respiratory trials on track and ensures patient safety during and after COVID-19.ERT 08.26.20
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Study: PROPEL Sinus Implant is More Effective Treatment Than Non Drug-Eluting Spacers
The device also saves money, as it helps reduce post-operative complications.Business Wire 08.14.20
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COVID-19 to Drive South Korean Ventilators Market to $50 Million by 2030
Seven major players account for more than 80 percent of the market, according to GlobalData.GlobalData 08.11.20
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MED-EL is First Hearing Implant Producer to Earn MDR Certification
Delayed by one year, the MDR will apply to all manufacturers selling medical devices within Europe.MED-EL 08.03.20
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Digital Health
Senseonics Launches New Remote Monitoring App for Android Users
Real-time glucose data and alerts of Eversense CGM users can now be remotely monitored on Android or iOS operating system.Business Wire 07.27.20
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Diagnostics
PerkinElmer Releases Dried Blood Spot Based COVID-19 Serology Test
Finger-prick sample collection device allows for decentralized sample collection and high-throughput testing.Business Wire 07.21.20
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Pandemic Expected to Drive Over-the-Counter Sales of Pulse Oximeters
Interest in pulse oximeters for COVID-19 management began to spike in early March.GlobalData 07.14.20
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India Must Address Challenges Faced by Private Labs Amid Pandemic Costs
Lack of sufficient protective gear, transport disruption, and the disrupted supply of test kits are some of the challenges private labs face.GlobalData 06.30.20
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PPE Shortage to Drive Use of Robots for COVID-19 Treatment
Robotic surgical systems and disposables market is expected to post double-digit growth in India for the next few years.GlobalData 06.23.20
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COVID-19 Drives a Need for Agility and Compassion
How one manufacturer adapted and responded to challenges created by the pandemic.Online Exclusives Rick McClain, President and COO of Milwaukee Electronics 06.16.20
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Chronic Disease
One Drop Unveils New AI Predictions for CGM Users
Announces long-term outcomes forecasts for diabetes-related biomarkers and overnight hypoglycemia predictions.PRNewswire 06.15.20
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Chronic Disease
Abbott's Freestyle Libre 2 iCGM Cleared in U.S. For Adults and Children with Diabetes
Automatically alerts users when their glucose is high or low without needing to scan the sensor.PRNewswire 06.15.20
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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
Surmodics Receives CE Mark for Drug Coated Balloon
Next gen device adds new technology to how physicians approach treatment of PAD.Business Wire 06.08.20
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Diagnostics
‘Pandemic Drone’ Spots COVID-19 Symptoms
About three months ago, drone-making company Draganfly began to strategize how drones might be able to help against COVID-19.Sam Brusco, Associate Editor 06.04.20
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Neurological
Noctrix Health's Wearable Restless Legs Syndrome Therapy Earns Breakthrough Status
NTX100 Neuromodulation therapy treats adults with primary moderate-severe RLS refractory to medications.PR Newswire 06.03.20
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Agilent Announces New Class 1 Triple Quadrupole LC/MS System
The system includes a preconfigured liquid chromatograph and mass spectrometer, as well as the clinical edition of Agilent MassHunter software.Business Wire 05.28.20
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Chronic Disease | Patient Monitoring
Medtronic Guardian Connect CGM Now Compatible with Android
Standalone CGM system alerts of potential high or low sensor glucose events up to 60 minutes in advance.GlobeNewswire 05.22.20
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Diagnostics
Value-Based Healthcare Driving POC Diagnostics Innovation
Point-of-care technologies can help minimize the cost of healthcare services.Online Exclusives Michael Barbella, Managing Editor 05.18.20
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Materials
Addressing the COVID-19 Crisis: Best Practices in PPE Development and FDA Review
How a supply partner can help a non-traditional medtech manufacturer navigate the regulatory process successfully.Online Exclusives Lise H. Moloney, Director of Business Development—Healthcare, Sciessent 05.18.20
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