ArtVentive Medical Group (OTC:AVTD) announced plans to launch its EOS peripheral vascular endoluminal occlusion system in the European Union following CE Mark approval for the self-expanding catheter device.
CE Mark
Spinal: Medtronic touts Euro win for 1st-of-its kind ReDux Plier
J&J subsidiary Codman Neuro lands CE Mark for clot removal device
Reverse Medical touts CE Mark in Europe, distribution deal in Japan
Reverse Medical won European approval for its MVP Micro Vascular Plug system for peripheral artery embolization and the company signed a deal with Century Medical for distribution of its products in Japan.
Eucomed guidance clarifies RoHS compliance for medical device companies
By Stewart Eisenhart, Emergo Group
European medical technology trade association Eucomed has published guidance distinguishing medical device compliance requirements of RoHS 2 (the Recast Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment 2011/65/EU) from those of the Medical Devices Directive (MDD 93/42/EEC).
CryoLife lands another win for its HeRo line
Medical device maker CryoLife won European regulatory approval for its HeRo graft system, the win coming on the heels of a FDA clearance for HeRo’s next generation adapter. Atlanta, Ga.-based CryoLife said a staged product roll-out in Europe will begin next month.
EBS lands CE mark, $3.9M for deep-brain vision loss treatment
Women’s health: Swedish regulators recommend preventative removal of PIP breast implants
It’s more bad news for women who received breast enlargement or reconstruction with implants manufactured by French medical device maker Poly Implant Prothèse, as healthcare regulators in Sweden recommended this week that all patients undergo preventative removal of the devices, even those with no indications of problems with the implants.
Diabetes: Echo aims for CE Mark with clinical trial of Symphony needle-free CGM
Philadelphia-based Echo Therapeutics (NSDQ:ECTE) is aiming for CE Mark approval in the European Union for its non-invasive, wireless Symphony continuous glucose monitoring system.