FDA clears vibrating belt to boost brittle bones in women facing osteoporosis
The FDA has granted a clearance to its first prescription medical device to help treat low bone density, with a wearable vibrating belt designed for postmenopausal women.
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Continue Reading »FDA clears AI-powered handheld that checks moles for skin cancer
Designed for use by primary care providers, the noninvasive system can help identify melanoma, basal cell carcinoma and squamous cell carcinoma.
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Continue Reading »FDA, CMS issue joint letter supporting increased oversight of lab-developed tests
“CMS does not have the expertise to assure that tests work; the FDA does,” wrote leaders from both federal agencies.
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Continue Reading »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
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 other authorities, is […]
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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