The management team at Respinova Ltd. is breathing easier with the FDA's 510(k) clearance of the company's Pulsehaler. Using pulsed air pressure, the device opens airways and clears secretions in patients with respiratory diseases. The clearance represents the device’s first endorsement by a regulatory agency, though the company hopes it will soon be joined by others.
A new FDA approval for United Therapeutics Corp.'s prostacyclin analogue, Tyvaso (treprostinil), has expanded its label to include the treatment of pulmonary hypertension associated with interstitial lung disease to improve exercise ability. The regulatory win could double the number of patients taking the medicine by the end of 2022, barring any COVID-19-related delay, said company President and CEO Michael Benkowitz.
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.
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