Novian Health gains FDA breakthrough designation for Novilase breast therapy

28 September 2021 - Novian Health has been granted breakthrough device designation from the U.S. FDA for its Novilase Interstitial Laser ...

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Procedural update on submission of Type I variations to EMA in March, April and May 2019

26 February 2019 - EMA is encouraging marketing authorisation holders intending to submit Brexit-related Type IA and Type IB variations ...

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Establishing the effectiveness of procedural interventions: the limited role of randomised trials

18 December 2018 - Procedural interventions comprise a large and growing component of medical care. Patients, physicians, health care organisations, and ...

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FDA approves VisuMax Femtosecond Laser to surgically treat nearsightedness

13 September 2016 - The U.S. FDA today approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure ...

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