The U.S. organ donation system is once again under pressure from both the executive and legislative branches thanks to media reports detailing an instance in which a surgeon refused to harvest organs from a potential donor who had not expired.

Plexāā Ltd. recently raised $4.5 million to support the upcoming U.S. launch of Bloom43, its wearable device that helps patients prepare for breast cancer surgery and reconstruction by using a technique called supraphysiological preconditioning.

Globus Medical Inc. reported the departure of its president and CEO, but sought to quell any concerns about what his leaving augurs for the future of the company.

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.

Heartflow Inc. continued the steady rhythm of med-tech companies filing to go public, with an S-1 submitted to the U.S. SEC on July 17. The company joins 15 others that have completed IPOs in 2025 and one other in process – Carlsmed Inc., which a company spokesperson told BioWorld is expected to begin trading on the Nasdaq on July 22.

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.

Abbott Laboratories’ second quarter results echoed Johnson & Johnson’s, with med tech performing the hero’s work with strong growth. Overall, Abbott slightly beat expectations with sales up 6.9% overall compared to 2Q 2024, largely boosted by the med-tech unit’s organic revenue increase of 12.2%, and worldwide sales for the quarter of $11.1 billion. Diabetes provided a particularly bright spot with 19.5% year-over-year growth for continuous glucose monitoring devices.

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.