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MedTech Intelligence

Volume 13 Issue No. 15


Jon Speer, Greenlight GuruWhat Are the Biggest Changes under EU MDR?

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.



How to create scalable connectivity ecosystems for in-hospital medical equipmentHow to create scalable connectivity ecosystems for in-hospital medical equipment

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.

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Featured Articles

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.

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.

Learn more about LOCTITE medical device adhesives at Ellsworth Adhesives


Marc Dufresne, Evidence PartnersHow Literature Review Automation Improves CER and
PER Program Management

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.

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.


Five Market, Investment, and M&A Trends in MedTech
Meet Five Legal and Policy Issues

By Louis Lehot, Foley Lardner

Medtech businesses show tremendous potential for profitability and growth, triggering a sparked interest in investment.

Siemens - Modern and integrated manufacturing execution systems in medical devices


Virtual Optimism:
Keep Remote Patient Monitoring and Telemedicine in Your Post-Pandemic Care Delivery Mix

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.


EU IVDR - Process, Data, Reporting & PlanningEU IVDR - Process, Data, Reporting & Planning

March 30 - April 27, 2021

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
(On-Demand Recording)

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

Details & Registration

MedTech Library

The Business Value of Cybersecurity in MedTechThe Business Value of Cybersecurity in MedTech

Sponsored By Irdeto

Build a secure line of defense for your devices against a growing range of cyberattacks. Irdeto's report in collaboration with Censuswide has identified clear ways for Health companies to improve customer and patient outcomes, make better data-driven decisions, increase trust, and generate more revenue.

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