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Bring new technology from ideation to the marketplace Bring new technology from ideation to the marketplace Bring new technology from ideation to the marketplace Bring new technology from ideation to the marketplace
  • Capabilities
    • Commercialization
    • Mechanical & Electrical Design/Engineering
    • Software & Web Development
    • Design & Human Factors
    • Quality Management
    • Clinical Verification, Regulatory, & Reimbursement Strategy
    • Technology: Planning, Protecting, & Documenting
  • Expertise
    • Why Simbex?
    • Portfolio
    • Wearables
    • Commercialization Centers
    • Technology Transfer Offices
    • News & Blog
  • About
    • Leadership
    • Our Team
    • Our Story
    • Culture
    • Careers
  • Get Started

News

 How can the FDA better support the development of medical technologies, including digital health technologies and diagnostics, for use in non-clinical care settings, such as at home?

How can the FDA better support the development of medical technologies, including digital health technologies and diagnostics, for use in non-clinical care settings, such as at home?

September 12, 2023

From reimbursement challenges, regulatory clarity for low-risk devices, to the rise of AI in home health, here is our perspective on the recent FDA call for comments! simbex-blog-pdf

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 FDA Detailed Expanded Use of Remote Regulatory Assessments in New Guidance and CMS Proposed Updates to Remote Therapeutic Monitoring in 2023 Fee Schedule

FDA Detailed Expanded Use of Remote Regulatory Assessments in New Guidance and CMS Proposed Updates to Remote Therapeutic Monitoring in 2023 Fee Schedule

September 12, 2023

FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across [...]

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 FDA Detailed Expanded Use of Remote Regulatory Assessments in New Guidance and CMS Proposed Updates to Remote Therapeutic Monitoring in 2023 Fee Schedule

FDA Detailed Expanded Use of Remote Regulatory Assessments in New Guidance and CMS Proposed Updates to Remote Therapeutic Monitoring in 2023 Fee Schedule

August 7, 2023

FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across [...]

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 Q1 Medical Device Recalls Linked to Unprecedented Level of Faulty Manufacturing and CMS announces Transitional Coverage for Emerging Technologies

Q1 Medical Device Recalls Linked to Unprecedented Level of Faulty Manufacturing and CMS announces Transitional Coverage for Emerging Technologies

July 11, 2023

According to the most recent "U.S. Product Safety And Recall Index" report by Sedgwick, manufacturing defects are the leading cause for product recalls in 2023 through the month of March.

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 Embracing Elegance in Medical Device Design: A Path to Exceptional Solutions

Embracing Elegance in Medical Device Design: A Path to Exceptional Solutions

June 26, 2023

In medical device engineering, the pursuit of elegance in design goes far beyond surface aesthetics, embodying a philosophy that seamlessly blends form, function, and usability to create [...]

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 AAMI and BSI Partner to Publish Guidance on Artificial Intelligence and Reimbursement lags for Prescription Digital Therapeutics

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence and Reimbursement lags for Prescription Digital Therapeutics

June 2, 2023

Read about AAMI and BSI partner is to publish guidance on artificial intelligence and reimbursement lags for prescription digital therapeutics.

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 FDA Issues Predetermined Change Control Plan for AI/ML-Enabled Device Draft Guidance and EPA proposes rules on EtO medical device sterilization

FDA Issues Predetermined Change Control Plan for AI/ML-Enabled Device Draft Guidance and EPA proposes rules on EtO medical device sterilization

May 9, 2023

Read about the FDA-issued Marketing Submission Recommendations and the new rules the EPA has proposed for medical device sterilization.

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 Developing Multi-Sensor Solutions for Health & Wellbeing

Developing Multi-Sensor Solutions for Health & Wellbeing

May 4, 2023

Last Month, I traveled to the NIH headquarters in Bethesda, MD for the semi-annual meeting of the External Collaborative Panel (ECP) for the Limb Loss and Preservation Registry (LLPR). For the [...]

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 Examples of Diagnostic Tools in Action

Examples of Diagnostic Tools in Action

April 19, 2023

In our last article, we discussed how Simbex’s approach to diagnosing and resolving performance issues throughout the medical device development process, using design techniques such as building [...]

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 Diagnosing Problems During Medical Device Development

Diagnosing Problems During Medical Device Development

April 19, 2023

The word diagnosis is made of up of two Greek roots meaning “to know throughout” or to “understand completely”.  We usually think of diagnosis in the context of illness, but it applies to problem [...]

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Simbex

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