Regulation Archives - Page 98 of 100

08 Aug 18

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Cianna Medical to expand the indication…

FDA extends indication of Cianna’s SAVI SCOUT reflector to include localization of soft tissue

Viveve Medical secures FDA approval to continue VIVEVE II clinical trial

08 Aug 18

Viveve Medical has secured the US Food and Drug Administration’s (FDA) approval to continue with Viveve Treatment of…

Particle Sciences secures patent for device to provide medication to tympanic membrane

06 Aug 18

Lubrizol’s Particle Sciences has received patent for a medication delivery device to the tympanic membrane.

Hologic wins $4.8m in patent infringement lawsuit against Minerva Surgical

30 Jul 18

The US District Court for the District of Delaware has found that Minerva Surgical infringed two Hologic patents…

INSIGHTEC gets FDA nod to start clinical study of MR-Guided focused ultrasound to treat AD

26 Jul 18

INSIGHTEC has secured approval from the US Food and Drug Administration (FDA) to begin clinical study using its…

Bayer to stop sales of Essure birth control devices in US

23 Jul 18

Bayer has informed the US Food and Drug Administration (FDA) that it will stop the sale and distribution…

AngioDynamics agrees to pay $11.5m in medical product claims case

20 Jul 18

Medical device distributor AngioDynamics has agreed to pay $11.5m to Federal governments and various states to settle the…

FDA grants pre-market approval for Stryker’s Surpass Streamline flow diverter

17 Jul 18

Medical technology Stryker has secured pre-market approval from the US Food and Drug Administration’s (FDA) for its Surpass…

SuperSonic gets FDA nod and CE mark for Aixplorer MACH 30 ultrasound system

Diagnostic ImagingApprovals

17 Jul 18

SuperSonic Imagine has secured 510(k) clearance from the US Food and Drug Administration (FDA) and CE mark approval…

FDA approves EchoNous Vein ultrasound-based tool