Twelve-month results from Fractyl Health Inc.’s real-world registry show sustained, significant weight loss following treatment with its Revita procedure, which uses ablation to resurface the mucosal lining of the duodenum.

Croívalve Ltd. raised $16 million in a series B financing round that will be used to fund a clinical trial in the U.S. looking at the safety and performance of its Duo system to treat patients with severe or greater symptomatic tricuspid regurgitation.

The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.

The U.S. FDA’s program to foster at-home health care is in its early stages and seeks to promote the development of technologies that will enable home health care services.

Medtronic plc looks to establish a moat around its diabetes pump position with an exclusive global partnership with Abbott Laboratories to develop a Freestyle Libre-based CGM that works with Medtronic’s smart dosing devices and insulin pump.

In what represents just the second PCT filing to have emerged from Valar Labs Inc., the company’s co-founders – Joshi Anirudh, Viswesh Krishna, and Damir Vrabac – describe their development of an AI-derived histologic signature for predicting patient outcomes to treatments for pancreatic cancer.

Lest there’s any confusion, Lucid Diagnostics Inc. published promising results from a third study showing the benefit of its non-invasive Esoguard test for detecting esophageal cancer and precancer conditions.

U.S. federal enforcement authorities rang up some significant settlements under the False Claims Act in the first half of 2024, amounting to a record $1 billion in total settlements, according to a report by the law firm of Gibson, Dunn & Crutcher LLP.

The U.S. Medicare program’s final rule for fiscal year 2025 inpatient care retains several controversial proposals, but some device makers fared well in their new technology add-on payment (NTAP) applications, including Dublin-based Medtronic plc, which won NTAP payments for two devices.

The U.S. FDA’s device center is working to refine its regulation of artificial intelligence algorithms, but the agency is recommending that industry be more forward-thinking in a blog that urges device makers to fully adopt a life cycle management mindset for these systems.