Australian respiratory imaging technology company 4dmedical Ltd. raised AU$150 million (US$105 million) in an institutional placement to accelerate U.S. adoption of its CT:VQ lung imaging software to bolster the company’s lead in software-based lung imaging. CT:VQ is 4dmedical's U.S. FDA-cleared, Software-as-a-Service technology that provides ventilation and perfusion insights from computed tomography imaging. A VQ scan is a specialized nuclear medicine procedure that evaluates both airflow (ventilation) and blood flow (perfusion) in the lungs. The test creates images showing how well airflow and blood flow are distributed through the lungs to identify areas of imbalance.

Fractyl's Revita reduces post-GLP-1 weight regain 70%

Six-month results from the REMAIN-1 trial demonstrated that Fractyl Health Inc.'s Revita reduced weight regain in patients who lost weight using GLP-1 medications by 70% compared to those who underwent a sham procedure. Designed to remodel the duodenal lining and restore normal communication between the brain and gut, Revita has received CE mark in the EU and U.K. and U.S. FDA breakthrough device designation for weight maintenance in people with obesity who discontinue GLP-1 therapies.

En Carta Lyme disease test wins FDA breakthrough designation 

En Carta Diagnostics SA received U.S. FDA breakthrough device designation for EC Pocket Lyme, its rapid, molecular diagnostic test for the early detection of Borrelia bacteria, which causes Lyme disease. The designation marks a pivotal step for the French startup as it will enable closer interaction with the agency, accelerating its route to market, and getting it to patients sooner.

Part B Medicare genetic testing spiked in 2024

A Jan. 28 report on Medicare spending on lab tests indicated that spending on many types of tests flattened between 2022 and 2024, but spending on genetic tests rose 20% between 2023 and 2024 to $3.6 billion. While the report does not specifically call out fraud as a driver of spending, the Department of Justice posted a Jan. 26 press release identifying a case of Medicare gene testing fraud that amounted to $52 million, just one of several examples of this kind of fraud.

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