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Market Access

Dollar, money
November 2, 2020
Dollar, money

COVID-19 Boosts PCR Diagnostics Market, to Exceed $6 Billion by 2030

By MedTech Intelligence Staff
No Comments

The PCR and real-time PCR molecular diagnostics was valued at $4 billion in 2019.

Continue reading →

Paul Banco, etherFAX
October 30, 2020
Paul Banco, etherFAX
MEDdesign

Securing Healthcare Technology During the Pandemic and Beyond

By Paul Banco
No Comments

Adopting new technology to ensure the health and safety of patients shouldn’t adversely affect security and privacy.

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Bill Enos, BSI Americas
October 28, 2020
Bill Enos, BSI Americas
MEDdesign

Remote, Telehealth-Driven World Poses New Concerns for Medical Device Security

By Bill Enos
No Comments

Medical device security needs to address the cyber-physical threats, not just patient health information risk.

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Catarina Carrão, Kolabtree
October 26, 2020
Catarina Carrão, Kolabtree
Soapbox

EU MDR Approval: Performing the Literature Search

By Catarina Carrão, Ph.D.
No Comments

Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous.

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Jennifer Fried, Explorer Surgical
October 23, 2020
Jennifer Fried, Explorer Surgical

Lack of Hospital Access Changes Med Device-Provider Interaction

By Maria Fontanazza
No Comments

Jennifer Fried, CEO of ExplORer Surgical, explains the stress that COVID-19 has placed on healthcare and the shift in how medical device reps are connecting with hospitals and healthcare providers.

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David Gwyn, Amplexor
October 22, 2020
David Gwyn, Amplexor
MEDdesign

Lessons from the Global Health Crisis: How to Get Product Information Management Right

By David Gwyn
No Comments

The pandemic has revealed some inadequacies in the way medical device suppliers manage regulated product information. The following is a look back on a challenging year and suggestions for practical improvements to cope with continued uncertainty in 2021.

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Caroline Loew, GlympseBio
October 21, 2020
Caroline Loew, GlympseBio
MEDdesign

Advancing the Biopsy: Biosensors as a More Accurate and Sensitive Disease State Diagnostic Tool

By Caroline Loew, Ph.D.
No Comments

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

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Nishant Panchal, Noteworth
October 19, 2020
Nishant Panchal, Noteworth
MEDdesign

How IoT is Reshaping Healthcare

By Nishant Panchal
No Comments

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.

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Phil Giarth, DataLink
October 13, 2020
Phil Giarth, DataLink
Soapbox

Population Health Solutions Can Improve Value-Based Quality Measures and Reporting During a Pandemic

By Phil Giarth
1 Comment

To achieve success in this market, device manufacturers should consider working with providers to help contain costs and enhance outcomes.

Continue reading →

FDA
October 7, 2020
FDA

FDA Hits Battelle With Warning Letter Related to Respirator Decontamination System Under EUA

By MedTech Intelligence Staff
No Comments

The agency stated that Battelle Memorial Institute is not in compliance with reporting requirements related to its CCDS.

Continue reading →

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