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MedTech Intelligence

Volume 13 Issue No. 03

Stephen Hahn, M.D.FDA Commissioner Hahn Departs, Encourages Staff to Follow ‘Science as Your North Star’

By Maria Fontanazza, Editor-in-Chief

Following a dramatic but brief tenure as commissioner, Stephen Hahn, M.D. used Twitter to leave his departing remarks on the morning of the inauguration.


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

A COMPLIMENTARY virtual event
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



Featured Articles

CDER Director Janet Woodcock to Serve as Interim FDA Commissioner

By MedTech Intelligence Staff

Woodcock was selected by outgoing Commissioner Stephen Hahn, M.D.

Remote Monitoring:
Shaping Heart Failure Treatment in 2021 and Beyond

By Philip B. Adamson, M.D., Abbott

Physicians are looking for better ways to treat patients with congestive heart failure. This includes the integration of remote monitoring and novel technologies.


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.

Read More!

Avoiding FDA Enforcement Actions:
Understanding Quality Systems

By Amy Scanlin, EAS Consulting Group, LLC

The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.

FDA: COVID-19 Put Spotlight on Digitization of Healthcare, and Importance of Data, Communication and Collaboration

By Maria Fontanazza

During last week’s Consumer Electronics Show, FDA Principal Deputy Commissioner Amy Abernathy talked about lessons learned from the pandemic and 2021 goals.

Abbott’s Virus Hunters Saw COVID Coming, Developed Three
Molecular Tests in 30 Days

By Maria Fontanazza

Andrea Wainer, EVP of Rapid Molecular Diagnostics at Abbott, shares how the company scaled up to supply the global market with more than 300 million COVID-19 tests in 2020 and the path forward.


How to optimize coatings and substrates for compatible medical devicesHow to optimize coatings and substrates for compatible medical devices

Sponsored By KRÜSS

Taking a close look at coatings, substrates, and surface preparation helps not only develop ground-breaking materials, but also enhances how well existing liquids and solids work together.

Read More!

Managing COVID-19:
How Medical Advancements Bring More Options for Patients and Doctors

By Bret Kevan Purcell, Ph.D., M.D., COL (Ret.), Medical Corps., U.S. Army; University of Florida

A review of new, successful treatment options for the novel coronavirus.

Cloud-Based Informatics Enable Smarter Antibiotic Use
and Infection Control

By Oliver Schacht, Ph.D., OpGen, Inc.

Incorporating bioinformatics platforms can ease the burden of tracking, analyzing and managing the use of antibiotics.


Telemedicine Cybersecurity Report: Android Patient-Facing Mobile AppsTelemedicine Cybersecurity Report:
Android Patient-Facing Mobile Apps

In this new whitepaper, Irdeto identified five B2C patient-facing Android telemedicine mobile apps that offer both synchronous and asynchronous virtual visit experiences to US consumers and are downloadable via Google Play and performed an extensive cybersecurity threat risk analysis of these apps.

Read More

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