ArcherDX Personalized Cancer Monitoring (PCM) tech designated by FDA as Breakthrough Device
BOULDER -- ArcherDX, Inc. announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Personalized Cancer Monitoring (PCM) technology, a... Read More
Wednesday January 15, 2020 0 comments
Oxalert EPO wearable device granted FDA Breakthrough Status
COLORADO SPRINGS -- The FDA has granted Breakthrough Device status to Med-botics, LLC for its Oxalert EPO TM (Enhanced Pulse Oximeter) device. The wrist-worn arousal device is designed to... Read More
Wednesday October 30, 2019 0 comments
Cochlear: FDA approves new Nucleus Profile Plus implant series with Android smartphone connectivity
CENTENNIAL -- Cochlear Limited ( ASX: COH), a global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's approval of the new Cochlear Nucleus ... Read More
Monday June 17, 2019 0 comments
Clovis Oncology receives Breakthrough Therapy designation for Rubraca
BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced theU.S. Food and Drug Administration(FDA) has granted Breakthrough Therapy designation for Rubraca (rucaparib) as a monotherapy... Read More
Tuesday October 2, 2018 0 comments
Array BioPharma colorectal cancer drugs receive Breakthrough Therapy Designation from FDA
BOULDER -- Array BioPharma Inc. (NASDAQ: ARRY) today announced it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for encorafenib (BRAFTOVI),... Read More
Tuesday August 7, 2018 0 comments
Array BioPharma: National Comprehensive Cancer Network, FDA OKs drug combo for melanoma
BOULDER -- Array BioPharma Inc. (Nasdaq: ARRY) announced that the National Comprehensive Cancer Network (NCCN) has updated the Clinical Practice Guidelines in Oncology for Melanoma to include... Read More
Monday July 16, 2018 0 comments
Fischer Medical receives FDA clearance to market Bloom2 cardiac stimulator
WHEAT RIDGE -- Fischer Medical announced its Bloom2 cardiac electrophysiology stimulator device has received U.S. Food and Drug Administration 510(k) clearance. The Bloom2 stimulator is a... Read More
Tuesday April 10, 2018 0 comments
Clovis Oncology submits NDA for rucaparib to treat recurrent ovarian cancer
BOULDER -- Clovis Oncology (NASDAQ: CLVS) today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for rucaparib as maintenance... Read More
Tuesday October 10, 2017 0 comments
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