In what represents its first patenting, Halifax, Nova Scotia-based Hollo Medical Inc. seeks protection for its product that is designed for inhaler users who are frustrated with cumbersome valved holding chambers and desire something more compact and portable.

Paragonix Technologies Inc. expanded access to its U.S. FDA-cleared Baroguard donor lung preservation system following a successful limited release with a handful of top transplant centers. In addition to critical temperature control, the new system provides active airway management to keep donor lungs in the best condition possible.

South Korean medical software firm Coreline Soft Co. Ltd. said it gained U.S. FDA 510(k) clearance for its artificial intelligence-based coronary artery calcification assessing solution, Aview CAC, while raising ₩18 billion (US$13.33 million) in a private placement.

Avicenna.AI SAS received clearance from the U.S. FDA for two of its artificial intelligence (AI)-based solutions, Cina-Ipe and Cina-Aspects, which provide for the detection of pulmonary embolism (PE) and the assessment of stroke severity in CT scans, respectively.

The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement. The FDA noted that it has received 129 reports of serious injury and 49 reports of fatalities associated with these devices, but did not indicate whether device malfunction was the source of these adverse events. Abiomed advises customers that the device should be implanted “with special care” in patients during active cardiopulmonary resuscitation, and to review some updated warnings in the product’s instruction for use statement.

Surgeon, CEO and founder of Hutom Corp., Woo Jin Hyung, is working to level the playing field in the operating room with artificial intelligence (AI) and big data, leveraging digital technology to optimize surgical outcomes.

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.