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Tag: medical devices

Top 5 AI Devices to Use in 2024

Artificial Intelligence has significantly transformed our daily lives over the past years. It has become an indispensable cornerstone of modern society. From personalized recommendations...

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Creating a Medical Device Bootscreen for QNX

Most if not all major devices (including medical devices) throughout the world have some form of a bootscreen. This often flashy but sometimes simple...

Overview of the New FDA Guidance on Cybersecurity

“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that provides...

5 top OT threats and security challenges | TechTarget

Operational technology (OT) is a broad term for all forms of computer technology that physically interact with the industrial world. From industrial control systems...

NMPA Roundup April 2024

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in April 2024. These updates are presented by...

Alafair Biosciences Receives Innovative Technology Contract from Vizient for VersaWrap® | BioSpace

Contract awarded for products that bring improvement to healthcare industry AUSTIN, Texas, April 3, 2024 /PRNewswire/ -- Alafair Biosciences, Inc, a leading innovator in the...

MDCG Guidance on Content of Clinical Investigation Plan: Specific Aspects | EU

The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent...

Health Canada Guidance on Management of Medical Device Applications: Overview | RegDesk

The article highlights the critical points of managing new submissions related to the products intended to be placed on the Canadian market. ...

CMS and Incyte Announce Collaboration and License Agreement for Povorcitinib in China and Southeast Asia

HONG KONG, China and WILMINGTON, Del., Apr 1, 2024 - (ACN Newswire) - China Medical System Holdings Limited (“CMS” or the “Group”) and Incyte (Nasdaq:INCY)...

NMPA Usability Engineering Guideline Issued for Medical Devices

NMPA published the “Medical Devices Usability Engineering Guideline” on March 19, 2024. NMPA believes that, in improving the usability and the design of devices...

Eight Mandatory and Ninety Recommended Standards to be Revised in 2024: Revisions Plan Asks Your Feedback

NMPA issued the draft version of “2024 Medical Device Industry Standards Revisions Plan” on March 22, 2024, with the deadline for feedback on March...

Vivos Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Operational Update | BioSpace

Positive Business Momentum and Sales Pipeline Growth Following FDA 510(k) Clearance of Vivos’ Proprietary Oral Medical Devices to Treat Severe Obstructive Sleep Apnea Annual Operating...

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