medical device guru

Software Companies Jump Through Hoops for FDA Classification
Broadly defined, software as a medical device is any application used by providers to make clinical decisions. An increasing number of applications are now officially designated as FDA-regulated devices. Is it worth it to pursue this classification for your own...
November 2, 2015
Biologics, Wound Care, Infection Prevention
Tiny, Tattoo-Like Wearables Could Monitor Your Health
Patients in hospitals, elderly folks and people with heart problems might soon be wearing temporary tattoos instead of heart rate monitors or pulse oximeters. Professor Nanshu Lu and a team at the University of Texas at Austin’s Cockrell School of Engineering have...
November 2, 2015
Orthopedics and Spine
Back Pain Eased with Early Physical Therapy After Injury
(Reuters Health) – Starting physical therapy right after lower back pain begins may provide relief sooner compared to doing nothing, but makes little difference over the long term, a U.S. study suggests. Researchers followed more than 200 patients with recent...
October 28, 2015
Biologics, Wound Care, Infection Prevention
Avita Medical sends devices and personnel to help treat mass burn victims in Taiwan
Avita Medical Ltd., a regenerative medicine company specializing in the treatment of wounds and skin defects, today announced that doctors in Taiwan have reported positive results from using ReCell® to treat burn victims of June’s waterpark disaster, with medics saying...
October 28, 2015
Biologics, Wound Care, Infection Prevention
FDA: Theranos peddling “uncleared medical devices”MedCity News
One of Theranos’ top defenses against the Wall Street Journal‘s incisive exposé has been its good standing with the Food and Drug Administration. Well, looks like that’s crumbling. The FDA has said that Theranos’ “nanotainers” are actually “uncleared medical devices” that are being wrongfully...
October 28, 2015
Diagnostics & Healthcare News
Is Medtech Holding the Future of Wireless Power?
Eight years after it was founded with MIT-based technology, WiTricity appears ready for the bigtime with its wireless resonant energy transfer system, which is based on finely tuned oscillating magnetic fields between coils at a distance. WiTricity (Watertown, MA) has...
October 28, 2015
Cardiovascular / Cardiology
Quitting Cigarettes Before Surgery Risky
MONTREAL — Quitting smoking before lung surgery is a good thing, but doing it too soon before the procedure might not be, a researcher said here. In a single-institution cohort, patients who quit smoking within a month of their thoracoscopic...
October 28, 2015
Surgery and Surgical Robotics
Robotic Surgeries Positioned to Surge Over Next Five Years
U.S. surgeons predict a big increase in robot-assisted surgeries over the next five years, especially for colorectal and hernia procedures, according to a survey by RBC Capital Markets. About 15% of surgeries today involve the use of robots, and the...
October 27, 2015
Orthopedics and Spine
EU drugs agency recommends suspension of Medtronic implant
Europe’s medicines regulator has recommended the suspension of Medtronic Plc’s InductOs, an implant to help bone development, pending the resolution of issues at a U.S. plant where a sponge used in the implant is made. The European Medicines Agency (EMA)...
October 27, 2015
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