Last August.under the Trump Administration, HHS announced that FDA would not have premarket review authority and oversight over laboratory developed tests (LDTs), including for COVID-19 tests and EUAs. Recently, House Energy and Commerce Committee Democrats sent a letter to HHS Secretary Becearra uring that he reverse the decision of the previous administration and reinstate FDA […]
Turner Imaging Systems has received its CE Mark for its Smart-C ® Mini C-Arm portable fluoroscopy x-ray imaging device. This will allow the Smart-C, the world’s first highly portable mini c-arm, to be distributed throughout the EU countries as well as the UK. “Securing the CE Mark is a critical regulatory milestone and major step […]
Foldax has announced that it has successfully performed the first-in-man Tria Mitral Valve implant. This is another milestone for the Tria LifePolymer valve platform. Strategically, the mitral valve addresses an unmet global need for a more durable mitral valve that doesn’t require lifetime anticoagulants. This is especially important in the many areas where rheumatic fever […]
On the heels of last week’s announcement of the closing of its $12M Series A offering, Xenter, Inc. has announced the appointment of Scott Heuler as Senior Vice President of Global Sales & Marketing and Gary Baldwin as Chief Technology Officer in its Hospital Technologies business unit. Xenter is innovating new wireless technologies and techniques for […]
Transit Scientific”s XO Score Scoring Sheath Platform has been named a winner in the 2021 Medical Design Excellence Awards (MDEA). The MDEA is a premier design competition in the medtech industry, recognizing significant achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. Recently, the company received European CE Mark […]
Today, BioUtah, in conjunction with Centro Civico Mexicano, First Step House, International Cancer Advocacy Network, Mental Healthy FIT, Northern Utah Coalition, and Patel Family Investments, sent a letter to Utah’s congressional delegation expressing concern with the reintroduction of H.R. 3, The Lower Drug Costs Now Act. In the letter, the coalition states its concern about […]
Transit Scientific has announced that its XO Score® Scoring Sheath Platform has received CE Mark clearance in the European Union for treatment of peripheral artery disease and end stage renal disease. Last year, the company announced FDA clearance for the device. We’ve been thrilled to see the effective low-pressure dilatation and luminal gain achieved using our […]
Clene Inc. announced on Monday that the company received a Healthy Longevity Catalyst Award from the U.S. National Academy of Medicine (NAM) to accelerate the preclinical development of CNM-Au8, a bioenergetic nanocatalyst, for treatment of neuronal aging-related deficits and Alzheimer’s disease. The international award will fund preclinical study of CNM-Au8 nanocatalysis for the improvement of human health […]
The Centers for Medicare & Medicaid Services (CMS) has once again delayed the January 14, 2021 final rule to establish the Medicare Coverage of Innovative Technology (MCIT) program. In a rule published in the federal register May 18, CMS further delays the effective date of the program to December 15, 2021. In issuing the rule, […]
ARUP Laboratories on May 10 announced it has signed a strategic agreement with Massachusetts-based TellBio Inc. to use the company’s TellDx circulating tumor cells (CTCs) technology in several research applications. ARUP has also invested in TellBio as part of the startup’s series A financing round. Other funding partners include Crocker Ventures, Genetron Holdings Ltd (NASDAQ: […]
Xenter has announced the appointment of four additional industry leaders to its Board of Directors and the closing of a $12M Series A offering of preferred stock. “Xenter is transforming healthcare as an innovative Device-Data-Drug healthcare technologies startup,” said Kelvyn Cullimore, president and CEO of BioUtah. “The new additions to the board, including Utah life […]
Discussion around drug pricing often raises the issue of just how much NIH funding drives the development of new therapies. The general perception is that NIH funding is largely responsible for the creation and approval of new therapies. However, a new study by VitalTransformation (sponsored by BIO and PhRMA) finds that perception to be misguided. […]