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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

Blog

 Omnibus Bill Sets New Cybersecurity Requirements in the US and Common remote monitoring misconceptions

Omnibus Bill Sets New Cybersecurity Requirements in the US and Common remote monitoring misconceptions

March 1, 2023
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 FDA Final Rule Reduces Radiological Devices Reporting Requirements and the End of the COVID PHE Will Bring Reimbursement Changes

FDA Final Rule Reduces Radiological Devices Reporting Requirements and the End of the COVID PHE Will Bring Reimbursement Changes

February 1, 2023
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 MDCG offers workaround for legacy devices with expiring certificates and FDA proposes framework for human factors information in device submissions

MDCG offers workaround for legacy devices with expiring certificates and FDA proposes framework for human factors information in device submissions

January 1, 2023
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 FDA clarifies definition of devices vs. counterfeit devices and 2023 CMS fee schedule includes updates to RTM codes

FDA clarifies definition of devices vs. counterfeit devices and 2023 CMS fee schedule includes updates to RTM codes

December 1, 2022
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 FDA launches TAP Pilot and Proposes Breakthrough Status for Devices Addressing Health Disparities

FDA launches TAP Pilot and Proposes Breakthrough Status for Devices Addressing Health Disparities

November 28, 2022

Regulatory FDA launches TAP Pilot to speed access to safe and innovative medical devices The FDA has launched the TAP Pilot Program (Total Product Life Cycle Advisory Program) for manufacturers [...]

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 FDA Releases Final Clinical Decision Support Software Guidance and Plans to Address Bias in Pulse Oximeters

FDA Releases Final Clinical Decision Support Software Guidance and Plans to Address Bias in Pulse Oximeters

October 21, 2022

Regulatory FDA finalizes guidance on how clinical decision support software is regulated FDA has published final guidance on determining whether clinical decision support software is considered a [...]

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 FDA creates new category for OTC hearing aids and CMS no longer requiring CMNs for some DMEPOS

FDA creates new category for OTC hearing aids and CMS no longer requiring CMNs for some DMEPOS

September 20, 2022

Regulatory FDA creates new category of OTC hearing aids, issues PSAP guidance FDA finalized a much-anticipated rule that allows certain air conduction hearing aids to be available [...]

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 Dartmouth MedTech Spinouts: Stories of Academic-Industry Collaboration and Innovation Panel Moderated By Simbex CTO Jeff Chu

Dartmouth MedTech Spinouts: Stories of Academic-Industry Collaboration and Innovation Panel Moderated By Simbex CTO Jeff Chu

June 20, 2022

The Upper Valley is home to a growing number of MedTech companies that are changing how we detect, monitor and treat a variety of diseases. Simbex was excited to join the Magnuson Center for [...]

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 Building on Success: Dartmouth Innovations Accelerator for Cancer

Building on Success: Dartmouth Innovations Accelerator for Cancer

June 12, 2022
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 FDA Releases New Cybersecurity Premarket Guidance and Study Shows 10 Year Delay Before a New CPT Code is Reimbursable

FDA Releases New Cybersecurity Premarket Guidance and Study Shows 10 Year Delay Before a New CPT Code is Reimbursable

May 19, 2022

Regulatory US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions On April 8, 2022, the US Food and Drug Administration published a new draft [...]

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