Today, on Monday, March 20, 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional ...

As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains ...

The study will examine the safety and efficacy of Sooma Medical's device, Sooma 2GEN, in improving MDD as a home-based treatment. The device, worn as a cap, uses tDCS therapy, a non-invasive technique ...

Certification reinforces STORZ & BICKEL's leadership position in medical device design, ensures continued availability of devices worldwide TUTTLINGEN, Germany, July 20, 2023 /PRNewswire/ - STORZ & ...

Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in ...

The "3-Hour Virtual Seminar on US FDA and EU Medical Device Directive Requirements for DHF, DMR, DHR and TF/DDS" training has been added to ResearchAndMarkets.com's offering. This webinar will examine ...

Conformity with stringent new EU regulations for medical devices confirmed Allows for commercialization of Bentrio in EU member states; facilitates regulatory approval in various other countries Major ...

The US FDA has granted 510(k) clearance, expanding the label of BrainsWay’s Deep Transcranial Magnetic Stimulation (TMS) ...

Arthur Erdman, PhD, is the Richard C. Jordan Professor and a Morse Alumni Distinguished Teaching Professor of Mechanical Engineering at the University of Minnesota, specializing in mechanical design, ...

Please provide your email address to receive an email when new articles are posted on . The FDA has granted breakthrough device designation to Magnus Medical for its neuromodulation treatment of major ...