Clovis Oncology granted FDA Breakthrough Therapy designation for lung cancer treatment agent

Clovis Oncology granted FDA Breakthrough Therapy designation for lung cancer treatment agent

BOULDER - Clovis Oncology Inc. (NASDAQ: CLVS) announced the U.S. Food and Drug Administration has granted Breakthrough Therapy designation for its investigational agent CO-1686 for lung cancer... Read More

By: InnovatioNews Tuesday May 20, 2014 0 comments Tags: Boulder, Clovis Oncology, FDA, Patrick J.Mahaffy

Venaxis selling 8,335,000 common stock shares to raise $18.4M to advance APPY1 Test in U.S.

Venaxis selling 8,335,000 common stock shares to raise $18.4M to advance APPY1 Test in U.S.

CASTLE ROCK - Venaxis Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE-Marked Appy1 Test, announced a $2.40-per-share pricing... Read More

By: InnovatioNews Friday April 4, 2014 0 comments Tags: APPY1, Castle Rock, FDA, Venaxis

Cochlear Limited announces FDA approval and launch of its Nucleus Hybrid Implant System

Cochlear Limited announces FDA approval and launch of its Nucleus Hybrid Implant System

CENTENNIAL - Cochlear Limited (ASX: COH), a global leader in implantable hearing solutions, announced U.S. FDA approval and launch of the company's Cochlear Nucleus Hybrid Implant System. The... Read More

By: InnovatioNews Friday March 21, 2014 0 comments Tags: Centennial, Chris Smith, Cochlear Limited, FDA, J. Thomas Roland

St. Renatus gets $5M in new funding from Blue Ocean to commercialize nasal mist anesthetic

St. Renatus gets $5M in new funding from Blue Ocean to commercialize nasal mist anesthetic

FORT COLLINS - St. Renatus LLC has received an additional $5 million from Blue Ocean STR LLC to assist with its New Drug Application submission to the U.S. FDA, the company announced. The... Read More

By: InnovatioNews Wednesday March 19, 2014 0 comments Tags: Blue Ocean Holdings, Curt Richardson, FDA, Fort Collins, St. Renatus, Steve Merrick

Sophono receives FDA clearance to offer pre-sterilized hearing products to U.S. health care centers

Sophono receives FDA clearance to offer pre-sterilized hearing products to U.S. health care centers

BOULDER - Sophono Inc. , a manufacturer of abutment-free, implantable, bone-conduction hearing devices, announced it has received clearance from the U.S. Food and Drug Administration to offer the... Read More

By: InnovatioNews Monday December 2, 2013 0 comments Tags: Boulder, FDA, Peter Ruppersberg, Sophono

Sorin Group announces FDA approval for SMARTVIEW cardiac home monitoring system

Sorin Group announces FDA approval for SMARTVIEW cardiac home monitoring system

DENVER - Sorin Group (MIL: SRN), a global medical company and a leader in the treatment of cardiovascular diseases, has received FDA approval for and is beginning the U.S. launch of its SMARTVIEW... Read More

By: Steve Wednesday May 15, 2013 0 comments Tags: cardiac monitor, Denver, FDA, SMARTVIEW, Sorin Group, Stefano Di Lullo

Life science companies to get information boost at May 22 BioBooster event

Life science companies to get information boost at May 22 BioBooster event

BOULDER - Mid-stage life science companies are invited to attend BioBooster Series II on May 22 and learn the latest information about new U.S. Food and Drug Administration regulations. The free... Read More

By: Steve Thursday May 2, 2013 0 comments Tags: BioBooster II, Boulder, Faegre Baker Daniels, FDA

BiO2 Medical's IDE application for Angel Catheter gets FDA approval

BiO2 Medical's IDE application for Angel Catheter gets FDA approval

GOLDEN - BiO2 Medical , a Texas-based medical device manufacturer with RD and production operations in Golden, today announced it is among the first to receive FDA approval of an Investigational... Read More

By: Steve Wednesday May 1, 2013 0 comments Tags: Angel Catheter, BiO2 Medical, Christopher Banas, FDA, Golden