by admin | Nov 30, 2017 | All Devices, Heart Rate (Photoplethysmograpgy), Medically Validated Devices (FDA&CE), MobileApp, Screening Devices
FibriCheck: Overview FibriCheck is a medically certified screening and monitoring application on prescription for the detection of irregular heart rhythms, including atrial fibrillation. FibriCheck is a software-only solution that only requires the user to place...
by admin | Nov 29, 2017 | Latest News
Product design and development firm Cambridge Consultants has developed the new MagLense system to enable wireless power transfer to medical devices inside the body. The flexible, efficient and safe procedure does not require precise alignment with the implant and can...
by admin | Nov 29, 2017 | Latest News
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or...
by admin | Nov 29, 2017 | Latest News
The FDA’s Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. Qualification means that the FDA has evaluated the tool and concurs with...
by admin | Nov 29, 2017 | Latest News
If you are an engineer in the medical device industry, you probably have a love/hate relationship with the FDA-mandated design controls process. While implementing design controls can feel like a major damper on your creativity and productivity in the design process,...
