Learn more about LOCTITE medical device adhesives at Ellsworth Adhesives

MedTech Intelligence

Volume 12 Issue No. 46



FDAFDA Issues EUA for First At-Home Rapid COVID-19 Diagnostic Test

By MedTech Intelligence Staff

Lucira Health's single-use molecular test kit will be available for prescription home use in people age 14 and older.



Unlocking Medtech’s Future Potential with Connected Devices and ServicesUnlocking Medtech’s Future Potential with Connected Devices and Services

Sponsored By S3 Connected Health

Demand for hospitals to operate at peak efficiency is driving demand for services based around connected devices. Adding connectivity to devices and becoming a service provider can be challenging.

This whitepaper includes examples of how companies like ResMed, Abbott, and Fresenius are successfully using connected devices and services.

  • Actionable steps for navigating the complex environment of connected devices and services
  • Common use cases and how to leverage them at your company
  • Key considerations when adding connectivity to your devices

Read More!

Featured Articles


Ransomware and Data Breaches Top Threats in Health ITRansomware and Data Breaches Top Threats
in Health IT

By Maria Fontanazza, Editor-In-Chief

And medtech companies need to keep interoperability and security top of mind.


Josh Turpen, Jama SoftwareThe Top Trend for Medical Devices in 2021?
Putting Quality First

By Josh Turpen, Jama Software

Moving too quickly in the product development process can lead to mistakes.


COVID-19 Requires New Approach to Clinical Trials and Human Factors StudiesCOVID-19 Requires New Approach to Clinical Trials
and Human Factors Studies

By MedTech Intelligence Staff

An upcoming webinar will discuss the new methods and protocols that have emerged as a result of conducting trials and HF studies during the pandemic.

Market Access

Boston ScientificBoston Scientific Discontinues Lotus Aortic Valve Platform, Issues Global Recall

By MedTech Intelligence Staff

All commercial, clinical, R&D and manufacturing activities surrounding the product will end.

Digital Medicine

Nishant Panchal, NoteworthHow IoT is Reshaping Healthcare

By Nishant Panchal, Noteworth

As one of the nation’s largest industries, and one that is experiencing serious issues with cost, staffing and customer experience, healthcare is a prime candidate for IoT solutions.

Product Development

Caroline Loew, Ph.D., Glympse BioAdvancing the Biopsy:
Biosensors as a More Accurate and Sensitive Disease State Diagnostic Tool

By Caroline Loew, Ph.D., Glympse Bio

Physicians need technology that helps them track disease progression and response to therapy.


MedTech IntelligenceClinical Trials & Human Factors Studies during a Pandemic

Dec. 7, 12:00 to 1:30 pm EST

What you will learn:

  • Study challenges during a pandemic
  • FDA guidance on clinical studies during COVID-19
  • Strategies and procedures for clinical trials during a pandemic
  • Strategies and procedures for human factors studies during a pandemic
  • Long-term opportunities for more efficient clinical and human factors research based on lessons from COVID-19

Register Now!


Connected DevicesConnected Medical Devices and the Cloud

Dec. 16, 1:00 to 2:30 pm EDT

Our panel and presenters are an AAMI working group of Medical Device industry leaders who will share insights from their experiences in developing and launching cloud-based medical device functionality. Additionally, the program provides a “sneak preview” of recommendations the group is submitting to AAMI for a Consensus Report providing written industry guidance for Connected Medical Devices and the Cloud

  • R&D, Product Development and Engineering Teams will hear software integration and product development case studies for cloud application
  • IT/IS, Software and Data Teams will see successful software development, security and data strategy implementations
  • QA, RA Teams will discover strategies navigate compliance, safety and security concerns
  • Executive Leadership, Market Access, Digital Health and Connected Device Product teams will learn from the success of others already succeeding with Cloud strategies.

Register Now!


Computer Modeling & Simulation in MedTech Product Development & SubmissionsComputer Modeling & Simulation in MedTech Product Development & Submissions

A virtual conference | January 27-28, 2021, 11:00 AM - 4:00 PM ET

What you will learn:

  • The uses and limitation of CM&S in med tech product development
  • Simulation to support, enhance, or replace clinical studies
  • The business case for CM&S
  • FDA’s perspective of CM&S
  • Standards and validation of modeling data
  • Case studies of successful med tech CM&S
  • The promise of digital twins, personalized modeling, and 3D printing

Register Now!


EU IVDR Implementation StrategiesEU IVDR Implementation Strategies Virtual Workshop

February 24 – 26, 2021, 11:00 AM - 4:00 PM ET

EU IVDR will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, reporting, data management, and a reassessment of legacy portfolios. Even the largest and best-prepared companies struggle with implementation, which involves strategic thinking and buy-in at the highest levels. This interactive workshop convenes experts from major diagnostics companies, notified bodies, and consulting firms to share strategies, procedures, experiences, and challenges.

Register Now!

LinkedIn Facebook Twitter YouTube