Bellaseno GmbH began recruiting patients in Australia for two clinical trials of its resorbable breast scaffold products on Aug. 4. The company expects to enroll 10 patients with pectus excavatum, a structural deformity of the chest in which the breastbone presses inwards. Read More
Medtronic plc inked an agreement to combine its patient care technologies with a wearable, remote monitoring platform developed by Pasadena, Calif.-based Rockley Photonics Inc. The Bioptx contains compact, photonics-based sensors inside a wristband to monitor a range of biomarkers beyond standard blood pressure, heart rate, pulse oximetry and glucose levels, making Rockley and Medtronic’s development partnership, said Rockley Chair and CEO Andrew Rickman, “a terrific match.” Read More
Grand Pharmaceutical Group Ltd. acquired about 11% of the equity of Xeltis AG and will introduce Xeltis’ Axess to the greater China markets. Axess is a restorative hemodialysis access graft used for arteriovenous graft (AVG) patients with end-stage renal disease (ESRD). Read More
The U.S. Senate and House of Representatives have not yet come to terms on FDA user fee legislation, a quinquennial source of melodrama that leaves the agency in an awkward position with current employees. However, FDA principal deputy commissioner Janet Woodcock said recently that prospective employees are also watching how Congress handles its business, adding that some of these pending hires may take jobs elsewhere rather than wait on Congress to send a user fee bill to the White House. Read More
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD). Read More
The European Commission launched a new research initiative with $10 million from Horizon Europe, the E.U.’s research and innovation program, to create a cutting-edge decision-making tool to help clinicians and patients select the best lung cancer treatment based on each patient’s specific needs and circumstances. The I3Lung initiative brings together 16 international partners from Germany, Belgium, Denmark, Italy Sweden, Switzerland, the U.S. and Israel. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genbody, Vieworks, Wision. Read More
