Unveiling short-of-the-mark top-line results from the phase IIb trial with MS-1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI), Azurrx Biopharma Inc. CEO James Sapirstein told investors during a conference call that “even if we had shown great success” in the study, more work had to be done for the enzyme to be commercialized. “We need to fix our formulation,” he said. “I’ve been saying this for a long time. It’s not a surprise to us.”
Teleradiology company Nines Inc. won 510(k) clearance from the FDA for Ninesmeasure, an artificial intelligence (AI)-powered tool for measuring lung nodules. The Palo Alto, Calif.-based company says the new tool can help speed the diagnosis of certain respiratory diseases, resulting in better patient outcomes.
PERTH, Australia – With a fresh injection of A$28.9 million (US$22.4 million) in grant funding from the Australian government and a capital raise of A$40 million, 4dmedical Ltd. is well on its way to commercializing its first lung imaging product in the U.S. and Australia. 4dmedical’s X-ray velocimetry (XV) technology is the first FDA-cleared respiratory imaging solution that uses mathematical models and algorithms to convert sequences of X-ray images into four-dimensional quantitative data.
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