The clearance expands Galvanize’s pulsed electric field portfolio for soft tissue ablation, supporting broader lesion treatment and limited US commercial release. ...
The submission moves PorTal Access closer to a planned mid-summer launch, positioning Flexi-Port as a differentiated vascular access solution for oncology and long-term infusion therapy. ...
RAMP UP programme with Hitachi High-Tech America supports electronic genome mapping studies in AML and MDS ...
Designed to optimise the MRI fusion procedure workflow, ProMap Smart represents the next generation of automated prostate contouring technology...
IVDR-compliant PCR test supports the detection of 11 clinically relevant gastrointestinal pathogens from 1 sample...
Dave brings more than 25 years of executive leadership experience in medical devices, with particular depth in interventional and catheter-based therapies, regulatory strategy...
The recognition places Caracal’s nitrile examination glove within a vetted category of medical products meeting sustainability and safer chemical criteria for healthcare procurement. ...
The FDA marketing authorisation establishes a new Class II device category for Aurie’s automated reusable no-touch intermittent urinary catheter system, with launch planned in Veterans Health Administration spinal cord injury hospitals later this year. ...
The FDA 510(k) clearance advances Biozen’s BP1000, a handheld fingertip device designed to deliver clinically validated spot blood pressure measurements without an arm cuff or per-user calibration. ...
Mason has more than 25 years of experience in the medical device industry and more than a decade of executive-level healthcare leadership expertise...
