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Volume 13 Issue No. 15 |
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By Jon Speer, Greenlight Guru With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements. |
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SPONSORED RESOURCE |
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Sponsored By S3 Connected Health Connectivity is now a must when designing or redesigning in-hospital medical equipment. Data insights collected on connected medical devices can bring many benefits for vendors, healthcare providers, and patients; from improving healthcare outcomes to reducing the cost of care and device maintenance. This whitepaper details the key steps to consider when creating a secure, scalable connectivity ecosystem based around medical equipment in the hospital environment. |
How to create scalable connectivity ecosystems for in-hospital medical equipment| Featured Articles |
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Medtronic Recalls Thoracic Stent Graft Due to Fractures and Endoleaks By MedTech Intelligence Staff Reported issues related to the device include two injuries and one death. |
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Emerging Trends in Cardiovascular Devices By Saloni Walimbe, Global Market Insights A global need for less invasive medical procedures and high efficacy treatments has outlined the developments of cardiovascular devices. |
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SPONSORED CONTENT |
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By Marc Dufresne, Evidence Partners Beyond simply allowing for broader yet more efficient searches, leveraging software to automate literature reviews can organize references, assign screeners, and review screening decisions. This saves time, reduces bottlenecks, and, most importantly, leads to a highly transparent, standardized, and repeatable process that supports continuous CER and PER submissions across a product portfolio and for the life of a device. |
How Literature Review Automation Improves CER and|
Device Using AI to Detect Colon Cancer Wins FDA Authorization By MedTech Intelligence Staff GI Genius is based on machine learning and helps clinicians detect lesions in real time during a colonoscopy. |
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Soapbox Five Market, Investment, and M&A Trends in MedTech By Louis Lehot, Foley Lardner Medtech businesses show tremendous potential for profitability and growth, triggering a sparked interest in investment. |
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Soapbox By Donna Morrow, Noteworh As restrictions lift and in-person visits become viable again, the use of virtual care technology — particularly telemedicine and remote patient monitoring (RPM)—is here to stay. |
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Featured Quote — Andrea Wainer, Abbott |
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COMPLIMENTARY |
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COMPLIMENTARY Virtual Events The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, data management, reporting, and a reassessment of legacy portfolios. Preparation will involve strategic thinking and buy-in at the highest levels. Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred. For those who have not already begun planning for the change, it is urgent to begin now or face exclusion from the European market. March 30, 2021: EU IVDR Introduction (On-Demand Recording) April 6, 2021: Quality Processes and Documentation April 13, 2021: Clinical Evidence & Surveillance (On-Demand Recording) April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling April 27, 2021: Strategy and Planning |
The Business Value of Cybersecurity in MedTech
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