Category Archives: BioUtah News
BioUtah Recognizes Rare Disease Day 2023
BioUtah President and CEO, Kelvyn Cullimore, commented on Rare Disease Day held on February 28, 2023. “Today is Rare Disease Day 2023, a day being recognized in countries around the world. Here in Utah, Gov. Spencer J. Cox has declared February 28, 2023 Rare Disease Day in the state. We are marking this occasion with […]
SDNA Saliva Collection FDA 510(k) Class II Medical Device Clearance
SALT LAKE CITY, UTAH—Spectrum Solutions, LLC today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) Class II clearance to the SDNA Saliva Collection Device as a microbial nucleic acid storage and stabilization device. The SDNA device is driving a new era of healthcare that turns to salivary collection and preservation as a […]
Merit Medical Receives FDA Breakthrough Device Designation for the New SCOUT® MD™ Surgical Guidance System
Next-generation system helps improve surgical precision to enhance patient care in breast and other soft tissue cancer treatment SOUTH JORDAN, Utah, Feb. 16, 2023 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today the FDA has granted Breakthrough Device Designation for the SCOUT MD […]
Still on the Hill…
BioUtah continues to monitor issues of importance to our industry and engage with legislators on Utah’s Capitol Hill.
R-Zero Raises $105 Million Series C to Improve the Indoor Air We Breathe
R-Zero’s UV-C Technology Improves Indoor Air Quality for Millions of People; Reduces Reliance on HVAC Systems and Chemicals that Harm Environment
SINTX Technologies Announces Its New Utah Armor Facility Is Fully Operational
Facility will produce high-performance ceramic armor products for personnel, aircraft, and vehicles
SINTX Technologies Announces Closing of $12.0 Million Public Offering
SINTX Technologies Announces Closing of $12.0 Million Public Offering
BioUtah on Capitol Hill
The Utah State Legislature has hit its halfway point in the 2023 session. Since day one, BioUtah President and CEO, Kelvyn Cullimore, and industry lobbyist, Chris Bleak, have been on the Hill engaging with lawmakers on a number of issues that impact our industry. Yesterday, Cullimore testified before the House Health and Human Services Committee […]
US FDA 510(k) Clearance and CLIA-waiver for the fast and innovative BIOFIRE® SPOTFIRE® System and its BIOFIRE® SPOTFIRE® Respiratory (R) Panel
US FDA 510(k) Clearance and CLIA-waiver for the fast and innovative BIOFIRE® SPOTFIRE® System
Renalytix announces a c.$20.3 million private placement
Renalytix announces a c.$20.3 million private placement
Sumitomo Pharma Oncology Presented Preliminary Data From Phase 1/2 Clinical Study Evaluating Investigational Agent TP-3654 in Patients With Myelofibrosis at American Society of Hematology 2022 Annual Meeting & Exposition
Sumitomo Pharma Oncology presented new data from the ongoing Phase 1/2 study evaluating TP-3654.
Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in Multiple Sclerosis by Sanofi
SOUTH SAN FRANCISCO, Calif., Jan. 25, 2023 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced that its partner Sanofi has commenced dosing in a Phase 2 study […]
