FDA sets new record for novel device green lights in CDRH annual report
In what the FDA described as a “transformative year” for its Center for Devices and Radiological Health, the agency set a new record in issuing green lights to innovative medical devices and diagnostic tests, topping its history spanning more than four decades.
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Continue Reading »FDA OKs Neuralace’s nerve stimulation tech for diabetes pain
The original FDA nod for Neuralace’s Axon Therapy for nerve pain came after a decade of R&D. The road to its next regulatory nod was much shorter.
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Continue Reading »Mastering Design Controls: Ensuring Quality and Compliance in Medical Device Development
Click to Expand In medical device development, ensuring quality and compliance is vital to safeguarding patient well-being. Strict adherence to regulatory standards, such as those set by the FDA or […]
Continue Reading »The increasing demand for microfluidics devices
Ultra-precision mass production for microfluidics devices,
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Continue Reading »Artificial Intelligence, Part 2: Human Interaction, Liability, and Patient Safety
Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction.
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Continue Reading »Signati™ Medical, Inc. Receives FDA Approval for IDE Study
Signati™ Medical, Inc.Receives FDA Approval for IDE Study – read this article along with other careers information, tips and advice on BioSpace…
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Continue Reading »CDMOs Face Headwinds in 2023, Look to Slow Recovery
BioSpace spoke to analysts and players in the contract manufacturing and development organizations space to assess the challenges this year and what lies ahead in 2024.
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Continue Reading »ABK Biomedical announces that its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)
ABK Biomedical, Inc. announces its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
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Continue Reading »AdvaMed Joins National Campaign to Improve Supply-Chain Performance
The Biden Administration has launched a strategy to bring medical products and other necessities into the hands of more Americans more quickly.
Read the full article at: www.plasticstoday.com
Continue Reading »How Medtronic Designed Its Extravascular Defibrillator
A behind-the-design look at how Medtronic developed the Aurora EV-ICD (extravascular implantable cardiac defibrillator).
Read the full article at: www.mddionline.com
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