FDA Hosts Workshop for Neurostimulation Devices July 27, 2016 Session intended to explore patient experiences. Read More
CAPA, Validation Failings Prompt 483 at Canada’s RS Medical July 27, 2016 Storage conditions for rechargeable batteries triggered complaint. Read More
Medicare Look to UDI Acceptance for Billing July 27, 2016 CMS and FDA seem to have found a consensus on UDIs. Read More
Ava Launches Fertility Tracking Sensor Bracelet July 26, 2016 Bracelet is able to detect a woman’s entire fertile window. Read More
Tandem Announces Expanded Indication for Insulin Pump July 26, 2016 Insulin pump is cleared for children as young as 6 years old. Read More
Oscor Gets Warning Letter Over Quality System Issues July 26, 2016 Oscor is slacking in its production processes. Read More
India Places Coronary Stents on Drug List July 26, 2016 Change likely means price controls for stents. Read More
FDA Clears Syneron’s Ultra-short Wavelength PicoWay Laser July 25, 2016 Fat reduction device allows for specific targeting. Read More
Medtronic’s VariLoc Launches in China, 9 Other Countries July 25, 2016 Bone fracture device eliminates unnecessary penetration to nearby joints. Read More
Public Workshop on Third-Party Refurbishing of Devices Slated for October July 25, 2016 Sessions to address concerns about unqualified personnel refurbishing devices. Read More
Medtronic’s DBS Pocket Adaptors Receive Hazard Alerts July 25, 2016 Pocket adapters suffer from low current conductions. Read More