Khan and Maloney

Decentralized Clinical Trials: Considerations for Implementation

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

…available at https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt?elq=c35f8b9a94034655a63b0ff2a847c15c&elqCampaignId=2595&elqTrackId=33C31492255977A002E994D6B25854D7&elqaid=3421&elqat=1#:~:text=The%20FDA%27s%20Medical%20Device%20Development%20Tools%20%28MDDT%29%20program,in%20the%20development%20and%20evaluation%20of%20medical%20devices. RWE focus is shifting to R&D, early investments begin to pay off. Retrieved March 2021 available at https://www2.deloitte.com/us/en/insights/industry/health-care/real-world-evidence-study.html Overcoming Study-Patient Burdens in Medical Research, available at https://sanguinebio.com/overcoming-study-patient-burdens-in-medical-research/…

…available at https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt?elq=c35f8b9a94034655a63b0ff2a847c15c&elqCampaignId=2595&elqTrackId=33C31492255977A002E994D6B25854D7&elqaid=3421&elqat=1#:~:text=The%20FDA%27s%20Medical%20Device%20Development%20Tools%20%28MDDT%29%20program,in%20the%20development%20and%20evaluation%20of%20medical%20devices. RWE focus is shifting to R&D, early investments begin to pay off. Retrieved March 2021 available at https://www2.deloitte.com/us/en/insights/industry/health-care/real-world-evidence-study.html Overcoming Study-Patient Burdens in Medical Research, available at https://sanguinebio.com/overcoming-study-patient-burdens-in-medical-research/…

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Drive Healthcare Transformation with Enterprise-Level Infrastructure

Drive Healthcare Transformation with Enterprise-Level Infrastructure

By Arrow and Dell Technologies

Learn the key considerations and best-fit solutions for healthcare transformation that optimize operations for providers and ensure better outcomes for patients. Discover how the Arrow Electronics and Dell Technologies OEM…

Learn the key considerations and best-fit solutions for healthcare transformation that optimize operations for providers and ensure better outcomes for patients. Discover how the Arrow Electronics and Dell Technologies OEM…

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Boston Scientific Logo

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

…to work more closely with M.I.Tech to expand their international footprint.” The company expects to complete the transaction in the second half of 2022, subject to customary closing conditions.  …

…to work more closely with M.I.Tech to expand their international footprint.” The company expects to complete the transaction in the second half of 2022, subject to customary closing conditions.  …

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Mark Goldwasser
Soapbox

Three Key Considerations To Secure Funding

By Mark Goldwasser

…longer to complete. Devices should have FDA approval. Regulatory approval is critical for investors. If companies do not have FDA approval yet, they will need to document the steps and…

…longer to complete. Devices should have FDA approval. Regulatory approval is critical for investors. If companies do not have FDA approval yet, they will need to document the steps and…

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CuePath Blister Pack

Smart Solutions To Improve Patient Compliance

By Ken Piaggio, Vinay Gokhale

…only with a specific imaging system for a specified patient. Another example is tubeless automated insulin delivery (AID) systems with compatible smartphone control that are integrated with continuous glucose monitor…

…only with a specific imaging system for a specified patient. Another example is tubeless automated insulin delivery (AID) systems with compatible smartphone control that are integrated with continuous glucose monitor…

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Luke Otto headshot

Recruiting and Retaining Top Talent

By MedTech Intelligence Staff

…my next position?’” How To Find New Talent (or a New Employer) When it comes to finding top applicants, the best strategy is to talk to others in the field….

…my next position?’” How To Find New Talent (or a New Employer) When it comes to finding top applicants, the best strategy is to talk to others in the field….

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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

…that make it easier and faster for medical device companies to complete EU MDR and IVDR notified body submissions. The partnership brings together DistillerSR and the Akra Team’s strategic regulatory…

…that make it easier and faster for medical device companies to complete EU MDR and IVDR notified body submissions. The partnership brings together DistillerSR and the Akra Team’s strategic regulatory…

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Leo Petrossian Head Shot
Soapbox

The Need for Global Standards in Digital Health Platforms

By Leo Petrossian

…and facilitating positive patient outcomes. To fulfill these requirements, virtual health platforms must commit to delivering best-in-class data encryption, HIPAA and GDPR compliance, and certification by medical-grade quality management systems,…

…and facilitating positive patient outcomes. To fulfill these requirements, virtual health platforms must commit to delivering best-in-class data encryption, HIPAA and GDPR compliance, and certification by medical-grade quality management systems,…

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FDA Issues Final Guidance on Technical Performance Assessments of Quantitative Imaging in Premarket Submissions

By MedTech Intelligence Staff

…the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand and interpret the values provided by the quantitative imaging functions The FDA…

…the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand and interpret the values provided by the quantitative imaging functions The FDA…

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Garrett Schumacher

The Shifting Sands of Medical Device Cybersecurity Regulation

By Garrett Schumacher

…ventilator use during the current pandemic. The guidance also seems to associate various activities with the incorrect development phase or process. For example, it includes threat-modeling aspects from design time…

…ventilator use during the current pandemic. The guidance also seems to associate various activities with the incorrect development phase or process. For example, it includes threat-modeling aspects from design time…

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