Posts by rw-admin
Risk Management: A Total Product Life-cycle Process [Infographic]
Risk Management is a total product life-cycle process. It’s not something you only do at the beginning or the end. As long as you produce a medical device, you must remember to plan for Risk Management. Unfortunately, risk management efforts have a tendency to trail off and be forgotten once a product is launched. Don’t…
Read MoreOsiris Therapeutics Adds TruSkin™ to it’s Wound Care Portfolio
COLUMBIA, Md.–(BUSINESS WIRE)–Osiris Therapeutics, Inc. (NASDAQ:OSIR), the leading cellular regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, announced today the launch of TruSkin™, a cryopreserved, living skin allograft. TruSkin has been developed to provide healthcare professionals a new option for treating large, chronic wounds…
Read MoreSoftware 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 software? If your objective is to make it an indispensable tool in the healthcare and…
Read MoreTiny, 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 come up with a way to quickly print cheap, wearable biosensors. When the researchers were…
Read MoreBack 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 onset of lower back pain for a year, randomly assigning them to receive either physical…
Read MoreAvita 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 they have seen superior wound closure and better outcomes. A total of 12 people have…
Read MoreFDA: 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 shipped across state lines. These nanotainers, to be clear, are the tiny vials pictured above…
Read MoreIs 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 an agreement with Intel to power computing devices over a distance without a cord. And…
Read MoreQuitting 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 lobectomy to treat lung cancer had more complications than those with a longer time off…
Read MoreRobotic 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 figure could hit 35% in five years and 41% in 10 years, the survey indicates.…
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