Intuitive Surgical Could Help Usher in a New Era for Medtech

USA – Intuitive Surgical Could Help Usher in a New Era for Medtech

More than a decade ago Amazon recognized that it needed mass-cloud computing power, but didn't believe there was a third party service available to...
Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

USA – Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

Failing to submit trial data to ClinicalTrials.gov may start to cost drug and device makers, the US Food and Drug Administration (FDA) said Thursday...
Device Makers Call for Changes to FDA’s Biliary Stent Guidance

USA – Device Makers Call for Changes to FDA’s Biliary Stent Guidance

Medical device makers Boston Scientific and Cook are calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on 510(k) submissions...
MYnd Analytics stock rallies after FDA gives breakthrough status for company device

USA – MYnd Analytics stock rallies after FDA gives breakthrough status for company device

Shares of MYnd Analytics inc (NASDAQ:MYND) popped on Monday after the US Food and Drug Administration (FDA) granted breakthrough device designation for the company's...
FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert

USA – FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert

The US Food and Drug Administration (FDA) issued a safety communication on Friday to alert of a potential risk of eye damage in patients...
FDA rolls out plan to reduce third party 510(k) re-reviews

USA – FDA rolls out plan to reduce third party 510(k) re-reviews

Dive Brief: Responding to a mandate in the FDA Reauthorization Act of 2017 (FDARA), the agency Thursday released draft guidance delineating how the agency...
Appropriate Use of Consensus Standards: FDA Issues Draft and Final Guidance

USA – Appropriate Use of Consensus Standards: FDA Issues Draft and Final Guidance

To further promote international harmonization of device regulations, the US Food and Drug Administration (FDA) finalized guidance to aid manufacturers in appropriate use of...
Apple Sets the Stage for FDA Regulation on Two Types of AFib Mobile Medical Apps

USA – Apple Sets the Stage for FDA Regulation on Two Types of AFib...

The US Food and Drug Administration (FDA) granted two de novo classification requests on Tuesday on applications to be used with the Apple Watch...
Device Firms to Prep for Electronic Submission Shift Under FDA Proposed Rule

USA – Device Firms to Prep for Electronic Submission Shift Under FDA Proposed Rule

The US Food and Drug Administration (FDA) issued a proposed rule Wednesday that marks the official first step in shifting away from the current...
FDA Looks to Make FOIA Process Easier

USA – FDA Looks to Make FOIA Process Easier

The US Food and Drug Administration (FDA) on Wednesday proposed a new rulemaking that would ease the process by which the public can use...

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