Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).

With an FDA 510(k) clearance now in hand, Cloudcath Inc. is planning a phased launch of its remote monitoring platform for peritoneal dialysis (PD) patients. The company will make the system available on a limited basis in second half of 2022 “with broad U.S. availability increasing throughout 2023 and 2024,” Cloudcath CEO Aly ElBadry told BioWorld. The Cloudcath system continuously analyzes the dialysate fluid used in PD to detect early signs that a patient needs evaluation or intervention and then alerts both patients and clinicians.

The U.S. CMS has expanded the population of Medicare beneficiaries who are eligible for lung cancer screening via low-dose CT (LDCT) imaging. The news drew raves from stakeholders who also lauded the expansion of the facilities that can conduct the procedure, constituting a set of changes that advocates say will save thousands of additional lives.