The US Food and Drug Administration (FDA) approved new medical device products at a pace nearly twice that of the year prior, according to a new report just published by analysts at EP Vantage, the market intelligence branch of Evaluate.
A biopsy is the only sure way to diagnose skin cancer; however, having good confidence that a lesion is cancerous before a biopsy can reduce the number of unnecessary biopsies performed. A new tool developed by researchers at University of Texas at Austin uses three different mechanisms to image a lesion, potentially providing a new way to identify suspected tumors. It is currently undergoing pilot clinical trials.
Several companies are developing wearable biosensors in the form of wristbands; however, the co-founder of biosensing technology company Valencell says the ear is the best to place collect vital signs, and giants Intel and Apple have earbud ambitions as well.
One of the authors of a controversial and now-retracted paper purporting a stem cell breakthrough has been found dead in what appears to be a suicide, according to numerous reports, following an investigation that has alarmed researchers and rattled one of Japan’s most respected institutions.
List is for products that are ‘understood’ and do not present ‘risks’; The FDA released a list of 107 medical devices it will exempt from its 510(k) Premarket Notification Regulations as part of the agency’s efforts to streamline its approval process for products similar to those that have already undergone testing and trials.
Regulatory functions at the U.S. Food and Drug Administration (FDA) were set to undergo a major overhaul in the later months of 2014 after a year-long effort by the Agency recommended making scores of improvements to the way the agency is structured and regulates products.Regulatory functions at the U.S. Food and Drug Administration (FDA) were set to undergo a major overhaul in the later months of 2014 after a year-long effort by the Agency recommended making scores of improvements to the way the agency is structured and regulates products.
The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devices.
The Japanese government has set an enforcement date of November 25, 2014 for revised laws that regulate the country’s pharmaceutical and medical device markets.
The Food and Drug Administration issued a new guidance in August 2014 that exempts still more medical devices, some of them consumer devices, from its regulatory scope. This means the manufacturers of these devices, some of which are connected to apps, no longer have to go through the FDA’s 510(k) review process before they bring their product to market.
Cheyenne, WY (KGWN) – Cheyenne Regional Medical Center (CRMC) is one of the first hospitals in the world to use new cutting-edge equipment in its ICU.