On Call
FDA cuts back oversight of medical device data systems | MassDevice.com On Call
MASSDEVICE ON CALL — Makers of medical device data systems caught a major break this month as FDA regulators ruled that devices that collect and store information generated by other devices can skip the 510(k) process for premarket clearance.
The proposed change in regulation affects a wide range of devices, including wireless scales and glucose meters. The FDA defined "medical device data systems" as:
Patient group wants J&J probe over pelvic mesh | MassDevice.com On Call
MASSDEVICE ON CALL — The controversy over transvaginal mesh implants is heating up in Florida, with patient advocates calling on authorities to investigate Johnson & Johnson (NYSE:JNJ) and its leadership.
WebMD takes on Apple with its own health data tracking | MassDevice.com On Call
MASSDEVICE ON CALL — The race for an all-in-one health data tracking system just got another contender as WebMD announced its new Healthy Target system for collecting and storing information from sleep monitors, blood glucose meters and other health and fitness technologies.
Medtronic puts $17M into community chronic disease program | MassDevice.com On Call
Medtronic’s OUS move becomes a political football | MassDevice.com On Call
Google’s getting in on health-tracking, insiders say | MassDevice.com On Call
Where does the app store meet the FDA? | MassDevice.com On Call
MASSDEVICE ON CALL — A debate is growing between healthcare providers and Silicon Valley app-makers over the proper role and rate of regulation for mobile apps that may impact patient health.
From beer to bone implants: New uses for spent brewery grain | MassDevice.com On Call
MASSDEVICE ON CALL — A team of researchers is working out a new way to turn the brewery waste into orthopedic devices, leveraging substances naturally found in spent grain for bone grafts and implants, Medgadget reports.
French docs implant world’s 1st 3D printed spinal cage | MassDevice.com On Call
MASSDEVICE ON CALL — A team of French doctors were the 1st to implant a patient with a customized spinal cage, thanks to 3D printed technology and development by device maker Medicrea.
Medicrea’s UNiD system 1st creates 3D digital images of a patient’s spinal anatomy, using them as a blueprint to produce an inter-body device aligned perfectly to the patients’ spine. The cages separate the vertebrae to restore proper alignment, with a spinal screw for added stability.
Abiomed teams with Bay State schools to get veterans medtech jobs | MassDevice.com On Call
MASSDEVICE ON CALL — Device makers are joining forces with Massachusetts’ higher education to help military veterans get their foot in the door with a career in medtech.