FFRangio System

Medtronic To Acquire CathWorks

Medtronic announced that it has entered into a strategic partnership agreement with CathWorks, a privately held company headquartered in Kefar Sava, Israel, which developed the FFRangio System. Fractional flow reserve…

Medtronic announced that it has entered into a strategic partnership agreement with CathWorks, a privately held company headquartered in Kefar Sava, Israel, which developed the FFRangio System. Fractional flow reserve…

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Soapbox

AI-Driven Continuous Remote Patient Monitoring (cRPM) Empowers Telehealth

By Gary Manning

…the patient. Additionally, continuous remote patient monitoring (cRPM) may be deemed medically necessary for patients with certain acute and/or chronic conditions.[4] Stay up to date on the latest news, regulations…

…the patient. Additionally, continuous remote patient monitoring (cRPM) may be deemed medically necessary for patients with certain acute and/or chronic conditions.[4] Stay up to date on the latest news, regulations…

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Harvard SEAS/Michael Rosnach

Harvard Bioengineers Develop Biohybrid Heart Ventricles

By MedTech Intelligence Staff

Bioengineers from the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have developed the first biohybrid model of human ventricles with helically aligned beating cardiac cells. Using…

Bioengineers from the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have developed the first biohybrid model of human ventricles with helically aligned beating cardiac cells. Using…

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FDA

FDA To Host Committee Meeting on Identification of Skin Lesions Using Computer-Aided Devices 

By MedTech Intelligence Staff

The U.S. Food and Drug Administration (FDA) is holding a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss the topic of…

The U.S. Food and Drug Administration (FDA) is holding a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss the topic of…

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HHS Issues Guidance on Patient Privacy and Tracking Apps in Wake of Supreme Court Decision

By MedTech Intelligence Staff

On the heels of the Supreme Court ruling in Dobbs vs. Jackson Women’s Health Organization, where the right to safe and legal abortion was taken away, President Biden and U.S….

On the heels of the Supreme Court ruling in Dobbs vs. Jackson Women’s Health Organization, where the right to safe and legal abortion was taken away, President Biden and U.S….

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European Union Flag

European Commission Adopts Common Specifications for High-Risk Diagnostics

On July 4, The European Commission adopted common specifications for several types of high-risk diagnostics. The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal…

On July 4, The European Commission adopted common specifications for several types of high-risk diagnostics. The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal…

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Regulations

MHRA Responds to Trade Association Concerns with Transitional Guidance

By MedTech Intelligence Staff

Both the British Healthcare Trades Association (BHTA) and the British In Vitro Diagnostic Association (BIVDA) have published statements welcoming the U.K. Medicines and Healthcare products Regulatory Agency (MRHA) response, published…

Both the British Healthcare Trades Association (BHTA) and the British In Vitro Diagnostic Association (BIVDA) have published statements welcoming the U.K. Medicines and Healthcare products Regulatory Agency (MRHA) response, published…

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Khan and Maloney

Decentralized Clinical Trials: Considerations for Implementation

By Myla Maloney, MBA, BCMAS, Yosef Khan, MD, MPH, PhD

…more efficient product development, U.S. Food & Drug Admin., available at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-strategies-modernize-clinical-trials-advance (last updated Mar. 14, 2019). Van Norman G. A. (2021). Decentralized Clinical Trials: The Future of Medical Product…

…more efficient product development, U.S. Food & Drug Admin., available at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-strategies-modernize-clinical-trials-advance (last updated Mar. 14, 2019). Van Norman G. A. (2021). Decentralized Clinical Trials: The Future of Medical Product…

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Boston Scientific To Purchase Majority Stake of M.I.Tech

Boston Scientific Corporation has entered into a definitive agreement with Synergy Innovation Co., Ltd, to purchase its majority stake (approximately 64%) of M.I.Tech, a publicly traded Korean manufacturer and distributor…

Boston Scientific Corporation has entered into a definitive agreement with Synergy Innovation Co., Ltd, to purchase its majority stake (approximately 64%) of M.I.Tech, a publicly traded Korean manufacturer and distributor…

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Evidence Partners and Akra Team Join Forces To Help Medical Device Companies Accelerate Completion of EU MDR and IVDR Submissions

By MedTech Intelligence Staff

Evidence Partners, developer of AI-enabled literature review automation software and creator of DistillerSR, has announced a collaboration with Akra Team, a German-based strategic regulatory consultancy, to deliver end-to-end consulting services…

Evidence Partners, developer of AI-enabled literature review automation software and creator of DistillerSR, has announced a collaboration with Akra Team, a German-based strategic regulatory consultancy, to deliver end-to-end consulting services…

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