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FDA
March 16, 2017
FDA

FDA Releases Proposed List of 510(k) Exempt Class II Devices

By MedTech Intelligence Staff

The agency states this list of more than 1000 devices doesn’t have risks that warrant premarket notification.

Continue reading →

Pol Van Dorpe, imec
March 7, 2017
Pol Van Dorpe, imec
Soapbox

DNA Sequencing Becoming Routine

By Pol Van Dorpe, Ph.D., Yves Moreau

The 1000-dollar genome presents a big opportunity in medicine.

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Laura Johnson, Loftware
February 20, 2017
Laura Johnson, Loftware

5 Labeling Trends Affecting MedTech

By Laura Johnson

How the shifting supply chain landscape and regulatory requirements will impact your business.

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Allergan
February 13, 2017
Allergan

Allergan to Buy Zeltiq Aesthetics for Nearly $2.5 Billion

By MedTech Intelligence Staff

The acquisition adds to the company’s plastic surgery and regenerative medicine portfolio.

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Medtech, innovation
January 16, 2017
Medtech, innovation

Speedy and Efficient Implementation of Medical and Healthcare Software

By Richard Lu

How companies should be identifying user needs when developing software solutions.

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Medtech question
January 5, 2017
Medtech question

Trump’s Impact, Pricing, R&D Funding and Cybersecurity Among Top Trends of New Year

By MedTech Intelligence Staff

It’s too early to tell how the new administration will affect the device industry, but user fees, the ACA and the FDA regulatory process are top of mind.

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Top Health Trends 2017
December 20, 2016
Top Health Trends 2017

Report: President-Elect Trump’s Healthcare Approach Uncertain, Top 10 2017 Issues

By MedTech Intelligence Staff

‘Value’ is the common thread in PwC’s annual report on top health industry trends.

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Terrence Norchi
December 5, 2016
Terrence Norchi
MEDdesign

Building a Better Hemostatic Device: Why Collaboration Is Key

By Terrence W. Norchi, M.D.

The search for better ways to stop bleeding may benefit from international partnerships.

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November 30, 2016

Breathalyzer Helps Patients Non-Invasively Check Blood Glucose

By MedTech Intelligence Staff

The finger-prick alternative may help diabetic patients more effectively monitor their condition.

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MEDICAL, moble medical app
November 18, 2016
MEDICAL, moble medical app

MEDICA’s Medical Mobile App Competition Winners Announced

By MedTech Intelligence Staff

The world’s largest competition for mHealth apps focused on user experience, innovation and problem solving in healthcare.

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Columns

March 12, 2024

FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

By MedTech Intelligence Staff
FDA Logo

The new draft guidance proposes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and focuses on information FDA considers necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.”

February 28, 2024

Closed-Loop Technologies Reduce the Burden of Chronic Pain

By MedTech Intelligence Staff
Ashwini Sharan

Ashwini Sharan, M.D., Chief Medical Officer of the Neuromodulation Division at Medtronic, discusses the development of the company’s recently CE Marked Inceptiv closed-loop spinal cord stimulator system for chronic pain and how the company plans to further incorporate closed loop technologies in its neuromodulation pipeline.

February 27, 2024

NIST Releases Updated Cybersecurity Framework

By MedTech Intelligence Staff
NIST logo

The National Institute of Standards and Technology (NIST) has updated its Cybersecurity Framework (CSF) guidance document for reducing cybersecurity risk. The new 2.0 edition is designed for all audiences, industry sectors and organization types. This is the framework’s first major update since its creation in 2014.

February 21, 2024

Navigating Sterilization Options for Silicone Medical Implants

By James Darlucio
James Darlucio

How to choose the right sterilization method for silicone-based medical devices and a look at novel silicone technologies.

January 31, 2024

DiMe Convenes Industry Leaders to Streamline Commercialization of Digital Health Products

By MedTech Intelligence Staff
DiMe Logo

The Digital Medicine Society (DiMe) is partnering with PHTI, ZS, and other leading organizations to develop and launch core components of integrated evidence plans for digital health products to support faster regulatory approval and commercialization.

January 5, 2024

Flex To Provide Advanced Manufacturing Services for Asensus Surgical’s LUNA Robotic Surgical System

By MedTech Intelligence Staff
The LUNA Surgical System

“Flex’s proven track record of delivering complex electromechanical systems across diverse industries and deep understanding of the complex requirements for medical devices will enable us to accelerate time-to-market for our LUNA platform.”

December 13, 2023
MEDdesign

Navigating Global Regulations for SaMD

By Dhaval Shah
Dhaval Shah

Decoding the legal framework for faster time-to-market.

November 28, 2023
MEDdesign

Making the Most of Medical Wearables: Addressing Patient Adherence Challenges

By Jiang Li, Ph.D.
Jiang Li

Patient adherence is critical to maximizing the benefits of medical wearables. In this article, we look at the key challenges to patient adherence in clinical trials and healthcare settings, and how device developers, researchers and providers can collaborate to harness the full benefits of wearables.

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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