PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
Masimo Corp. managed to obtain and uphold an injunction against True Wearables Inc. regarding a pending patent application, which Masimo said would have disclosed a trade secret for pulse oximeters. However, the injunction is only a preliminary injunction, and thus the road ahead may ultimately yield a disclosure of a trade secret that Masimo has dedicated considerable resources to protect.
Patients who received Intersect ENT Inc.’s Propel sinus implant had fewer doctor visits, emergency department and urgent care visits and subsequent endoscopies following surgery for chronic rhinosinusitis, a real-world evidence study found.
The U.S. Preventive Services Task Force (USPSTF) has once again broached the question of whether screening for atrial fibrillation (AF) in asymptomatic patients is a worthwhile exercise in public health, and once again the answer is “we don’t know.”
Nextkidney BV has signed a deal to buy Dialyss Pte. Ltd. as it gears up to commercialize its home hemodialysis device Neokidney. The Singapore-based startup specializes in sorbent technologies for the regeneration of dialysate and has been a collaborator of Nextkidney’s for six years. The combined team will prepare for a clinical trial in Singapore, followed by a European multicenter trial and CE mark submission in 2023. Financial terms of the deal were not disclosed.
Akili Interactive Inc. is the latest in a growing field of med-tech startups that are merging with special purpose acquisition companies as a backdoor path to an initial public offering. On Wednesday, the digital medicine company reported plans to combine with Social Capital Suvretta Holdings Corp. I in a deal valued at approximately $1 billion.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Maxim Biomedical.