Posts Tagged fda

What Makes A Device Class III? FDA Proposes New Language To Clarify

Monday, March 31st, 2014 | Permalink

FDA issued a proposed rule that introduces five newly defined categories that describe situations for devices when a class III designation, requiring a PMA and other heightened standards, will always be necessary.

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What Makes A Device Class III? FDA Proposes New Language To Clarify

Benvenue Medical Touts Next-Generation Treatment For Vertebral Compression Fractures

Wednesday, March 26th, 2014 | Permalink

At the recent CIRCE meeting, researchers presented positive clinical data comparing Benvenue Medical Inc.’s Kiva vertebral compression fracture system versus Medtronic’s market-leading Kyphon kyphoplasty system, providing a boost for Benvenue, which is awaiting FDA 510(k) clearance of its device.

Taken from:
Benvenue Medical Touts Next-Generation Treatment For Vertebral Compression Fractures

FDA’s Mobile Health Guidance Removes Risk For Investors

Wednesday, February 12th, 2014 | Permalink

Investors and their limited partners really don’t like risk, especially not the kind due to uncertainty. Now, for developers of mobile health applications and their investors, at least one risk has been taken off the table: regulatory uncertainty. On September 23, the FDA published the much-anticipated final guidance on mobile medical apps.

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FDA’s Mobile Health Guidance Removes Risk For Investors

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