je.st
news
Tag: fda
Siemens Receives FDA Clearance for Multitom Rax Robotic X-ray System
2015-11-30 08:23:07| Industrial Machines - Topix.net
Siemens Healthcare has announced that the U.S. Food and Drug Administration has cleared the Multitom Rax , a universal diagnostic imaging system that enables a wide range of examinations in multiple clinical areas - from emergency medicine and interventional to pain management and orthopedics, and from conventional 2D radiography to fluoroscopy examinations and angiography applications - all in one room using one X-ray system.
Tags: system
siemens
clearance
receives
FDA declines expanded approval for Bristol-Myers' Opdivo drug
2015-11-28 01:31:21| Biotech - Topix.net
REUTERS: Bristol-Myers Squibb Co said the U.S. Food and Drug Administration declined to approve its immuno-oncology drug, Opdivo, for its expanded use to treat an additional type of advanced skin cancer. Bristol-Myers said it received a so-called complete response letter from the health regulator, which indicated the need for additional data in the BRAF mutated patient population.
Tags: drug
expanded
approval
fda
BIO Applauds FDA Approval of genetically engineered salmon.
2015-11-25 14:31:07| Industrial Newsroom - All News for Today
After regulatory review, U.S. Food and Drug Administration (FDA) approved genetically engineered (GE) AquAdvantage® Salmon for commercial marketing. In response, BIO President and CEO Jim Greenwood commended the FDA "for taking this very important step in the right direction for the advancement of animal biotechnology innovation." AquAdvantage Salmon, developed by BIO member AquaBounty Technologies, is genetically engineered to reach market weight earlier while using 25% less food.
Tags: approval
bio
salmon
engineered
FDA requests feedback on food labeling terminology.
2015-11-25 14:31:07| Industrial Newsroom - All News for Today
FDA is requesting feedback on use of the term "natural" in food labeling. Action is a response to consumers who have requested that the administration explore the use of the term "natural" on food labels, considering the changing landscape of food ingredients and production. FDA asks for public comment on whether it is appropriate to define the term natural; if so, how the agency should define natural; and how the agency should determine appropriate use of the term on food labels.
Tags: feedback
food
requests
labeling
PCI Medical Announces FDA 510(k) Clearance for ASTRA VR and ASTRA TEE Automated Reprocessors for Endovaginal/Endorectal Probes and TEE Ultrasound Probes
2015-11-25 11:31:10| Industrial Newsroom - All News for Today
Deep River, Connecticut PCI Medical is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration for the ASTRA VR and ASTRA TEE automated reprocessors used to facilitate the high-level disinfection of endocavity ultrasound probes. "The ASTRA VR and ASTRA TEE automated...
Tags: medical
clearance
tee
automated
Sites : [64] [65] [66] [67] [68] [69] [70] [71] [72] [73] [74] [75] [76] [77] [78] [79] [80] [81] [82] [83] next »