ArcherDX Personalized Cancer Monitoring (PCM) tech designated by FDA as Breakthrough Device

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 Tags: Boulder, ArcherDx, Jason Myers, FDA

Oxalert EPO wearable device granted FDA Breakthrough Status

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 Tags: Colorado Springs, Med-botics, FDA, Oxalert EPO, Richard Dutton

Cochlear: FDA approves new Nucleus Profile Plus implant series with Android smartphone connectivity

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 Tags: Centennial, Cochlear Limited, Nucleus Profile Plus Implant, Tony Manna, Patricia Troutwein, FDA

Clovis Oncology receives Breakthrough Therapy designation for Rubraca

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 Tags: Boulder, Clovis Oncology, Rubraca, Patrick J. Mahaffy, FDA

Array BioPharma colorectal cancer drugs receive Breakthrough Therapy Designation from FDA

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 Tags: Boulder, Array BioPharma, Victor Sandor, FDA

Array BioPharma: National Comprehensive Cancer Network, FDA OKs drug combo for melanoma

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 Tags: Boulder, Array BioPharma, melanoma, Ron Squarer, FDA

Fischer Medical receives FDA clearance to market Bloom2 cardiac stimulator

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 Tags: Wheat Ridge, Fischer Medical, Bloom2, FDA, Wes Rogers

Clovis Oncology submits NDA for rucaparib to treat recurrent ovarian cancer

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 Tags: Boulder, Clovis Oncology, Rucaparib, Patrick J. Mahaffey, FDA