Scoop.it
FDA clears vibrating belt to boost brittle bones in women facing osteoporosis
Posted on Leave a Comment
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.
Read the full article at: www.fiercebiotech.com
Continue Reading »FDA clears AI-powered handheld that checks moles for skin cancer
Posted on Leave a Comment
Designed for use by primary care providers, the noninvasive system can help identify melanoma, basal cell carcinoma and squamous cell carcinoma.
Read the full article at: www.fiercebiotech.com
Continue Reading »FDA, CMS issue joint letter supporting increased oversight of lab-developed tests
Posted on Leave a Comment
“CMS does not have the expertise to assure that tests work; the FDA does,” wrote leaders from both federal agencies.
Read the full article at: www.fiercebiotech.com
Continue Reading »FDA sets new record for novel device green lights in CDRH annual report
Posted on Leave a Comment
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.
Read the full article at: www.fiercebiotech.com
Continue Reading »FDA OKs Neuralace’s nerve stimulation tech for diabetes pain
Posted on Leave a Comment
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.
Read the full article at: www.fiercebiotech.com
Continue Reading »The increasing demand for microfluidics devices
Posted on Leave a Comment
Ultra-precision mass production for microfluidics devices,
Read the full article at: www.todaysmedicaldevelopments.com
Continue Reading »Artificial Intelligence, Part 2: Human Interaction, Liability, and Patient Safety
Posted on Leave a Comment
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.
Read the full article at: www.biospace.com
Continue Reading »Signati™ Medical, Inc. Receives FDA Approval for IDE Study
Posted on Leave a Comment
Signati™ Medical, Inc.Receives FDA Approval for IDE Study – read this article along with other careers information, tips and advice on BioSpace…
Read the full article at: www.biospace.com
Continue Reading »CDMOs Face Headwinds in 2023, Look to Slow Recovery
Posted on Leave a Comment
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.
Read the full article at: www.biospace.com
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)
Posted on Leave a Comment
ABK Biomedical, Inc. announces its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
Read the full article at: www.biospace.com
Continue Reading »