Researchers from the University of Chicago and Northwestern University have filed for protection of an mobile application to track individualized patient needs, engagement in continuous positive airway pressure machine use, and the correlation of risk behaviors to determine sleep apnea treatment progress.

Medical device manufacturers based in China may feel the FDA has a bullseye on their backs, but two firms located in Canada were the subjects of recently posted FDA warning letters.

In what undoubtedly came as a response to Medtronic plc’s recently reported Small Annuli Randomized to Evolut or SAPIEN Trial trial results that showed a decisive advantage for its Evolut transcatheter aortic valve replacement system in patients with a small aortic annulus, Edwards Lifesciences Corp. reported the results from an analysis of data from its Placement of Aortic Transcatheter Valve trials of the Sapien 3 valves showing “excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or sex.”

Isotope Technologies Munich SE (ITM) raised €188 million ($204 million) in a funding round that will largely be used to advance and expand the company’s radiopharmaceutical pipeline. The funds, which come a year after ITM raised €255 million, are a sign of growing investor interest in the company’s products and the radiopharma market, Steffen Schuster, CEO of ITM, told BioWorld.