The U.S. FDA expanded the approval for use of Boston Scientific Corp.’s Watchman Flx and Watchman Flx Pro left atrial appendage closure (LAAC) devices to include post-ablation patients, bringing good news to the company as it preps for its second quarter earnings report on July 23.

Australia’s Therapeutic Goods Administration proposed to adopt a 2021 EU guideline on quality documentation for drugs used with medical devices including co-packaged products, a demonstration of the impact of EU regulations on Australia’s own regulatory approach.

Palmetto GBA of Columbia, S.C., issued a draft local coverage determination that provides coverage for biomarker testing to stratify a patient’s risk associated with ductal carcinoma in situ.

The U.S. False Claims Act (FCA) is not the only statute governing the submission of false claims to federal agencies thanks to the more than 30 states with their own versions of the FCA. However, the federal government is providing states with more incentives to amplify their FCA-related activities, a development that raises the stakes for companies in the life sciences.

The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech incubators to support emerging Australian biopharma and med-tech startups.

Uromems SAS received investigational device exemption (IDE) approval from the U.S. FDA, and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM), to begin a pivotal trial of its Uroactive smart implant.

The U.S. Centers for Medicare & Medicaid Services (CMS) has issued a draft coverage memo for cardiac contractility modulation (CCM), which offers coverage with evidence development for the company’s Optimizer line of devices. CMS said it will issue the final coverage memo by Oct. 8, 2025, which will mark the achievement of an objective the company set for itself more than two decades ago.

The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.

Caranx Medical SAS secured clearance from the U.S. FDA for Tavipilot Soft, its AI-powered software which provides real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software, which tracks anatomical and instrumental landmarks in real-time to enable precise and accurate heart valve positioning and delivery, will allow a broader number of cardiologists to perform this complex procedure.

For the second time in five years, the Centers for Medicare & Medicaid Services (CMS) has proposed to erase the inpatient-onlylist over a span of three years, stating that physicians are capable of deciding which site of service is best for their patients.