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Tag: medical device

CIRC Announces 2023 Annual Results

HONG KONG, Apr 17, 2024 - (ACN Newswire) - China Isotope & Radiation Corporation (“CIRC” or the “Company” , together with its subsidiaries, the “Group”;...

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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...

Vienna-based Syntropic secures seven-figure funding to develop new treatment for Major Depressive Disorder | EU-Startups

Syntropic Medical, a medical device company spun out of the Institute of Science and Technology Austria (ISTA) by Mark Caffrey, Jack O’Keeffe, Dr. Alessandro...

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...

Helius Medical Technologies, Inc. Announces Partnership with Lovell® Government Services to Expand Reach of PoNS Therapy™ | BioSpace

Lovell is an approved supplier to the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD) Over 28,000 cases of multiple sclerosis (MS)...

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. ...

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