Vicore Pharma Holding AB was granted a U.S. FDA breakthrough device designation for Almee, a cognitive behavioral therapy (CBT) software, to be used as an adjunct treatment by patients with anxiety symptoms due to pulmonary fibrosis. Vicore developed the nine-week CBT digital therapy in partnership with Alex Therapeutics AB.
Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met.
In what represents the first patenting from Immersive Reality Group LLC, the company’s co-founders describe their Intellighealth system for detecting the early onset of respiratory diseases using artificial intelligence and wearable remote health monitoring technologies.
Lumitex Inc. seeks patent protection for a phototherapeutic apparatus for treating inflammatory conditions, with a particular focus on treating acute respiratory distress syndrome.
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee has a lot to discuss Nov. 17, but only one voting question: Does the evidence demonstrate that Merck & Co. Inc.’s gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained chronic cough?
Zig Therapeutics Inc. reported on new patented systems and methods for the remote diagnosis and treatment of a bacterial infection in individuals with chronic respiratory diseases experiencing acute respiratory exacerbations using automated color vision sputum analysis.
One of the key advances in regenerative medicine has been the engraftment of external epithelial stem cells to supplement or replace damaged native cells. However, the difficulty in engrafting internal tissues has hindered the long-term rescue of diseased internal epithelia, such as those in the respiratory airways.
Premature babies face challenges in the neonatal intensive care unit (NICU) as their heart, lungs and neurological system continue to develop outside the womb. Roughly half of neonates born at 26 weeks to 28 weeks gestation experience respiratory distress. These infants often need extra oxygen and help breathing, as well as constant monitoring to ensure oxygen is absorbed and carbon dioxide (CO2) is dispelled. To that end, Etiometry Inc. received FDA clearance for its IVCO2 Index, a software tool for use in monitoring risk of hypercapnia in NICU patients weighing less than 2 kg.
Deep learning algorithms are used to remotely monitor and track just about everything these days and now that includes ordinary and chronic cough. Hyfe Inc. has launched an AI-driven remote patient monitoring (RPM) program designed to monitor cough for a whole range of serious ailments at virtual hospitals, remote care and telehealth programs across the U.S.
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