ResMed has completed its $340 million acquisition of Noctrix Health, expanding its portfolio with a device for restless legs syndrome. The device noninvasively stimulates nerves to treat the condition.

Smith+Nephew has introduced its next-generation Leaf patient monitoring system in the US. The system is designed to prevent hospital-acquired pressure injuries with a wearable sensor that monitors patient mobility and provides real-time updates on turning status.

Australian medical imaging company 4DMedical has agreed to acquire Austria-based contextflow, an AI lung imaging firm, to enter the European market.

Picard Medical has completed an animal study of its Emperor Total Artificial Heart, a fully implantable, driverless system that provides pulsatile flow. The study, conducted at the University of Arizona, found that the device provides stable hemodynamic support without intraoperative failures.

The FDA is increasingly emphasizing transparency and explainability in the review of AI and machine learning-based software as a medical device, moving beyond performance metrics. Transparency can be demonstrated by tracing model outputs to data and design decisions, defining human oversight and making outputs clinically interpretable.

The FDA has approved Foundation Medicine's FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Pfizer's Talzenna in combination with Xtandi to treat patients with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer. Foundation Medicine now has nine FDA-approved companion diagnostic indications for prostate cancer.

Philips has received FDA 510(k) clearance for Elevate Plus, an artificial intelligence-powered software suite for the Epiq Elite and Affiniti ultrasound systems. The suite includes tools such as Auto Measure Abdomen to automate routine measurements and reduce variability, and Koios AI decision support for classifying breast lesions and thyroid nodules.

SKIA has received FDA 510(k) clearance for its SKIA HEAD augmented reality surgical guidance system, which projects 3D anatomical models onto a patient's body using a portable tablet and high-precision sensors. SKIA plans to enter the US market through a partnership with Structure, a developer of 3D sensing technology.