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Two prominent senators called for an inquiry into the agency’s handling of device recalls through an open letter published last month.

Read the full article at: www.mddionline.com

As it races toward FDA review of its light- and sound-based neuromodulation device, Cognito Therapeutics is taking an even closer look at the tech.

Read the full article at: www.fiercebiotech.com

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

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

“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

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

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

Ultra-precision mass production for microfluidics devices,

Read the full article at: www.todaysmedicaldevelopments.com

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

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