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.

Mediwound Ltd. reported that the Nexobrid expanded treatment access protocol achieved complete debridement in 94.9% of adults and all children treated and removed all eschar within 24 hours. The results put more power behind a partnership with Vericel Corp. that introduced Nexobrid, an enzymatic debridement agent for severe thermal burns, into the U.S. in the fourth quarter of 2023 and increases the likelihood of an indication expansion into pediatrics.

Neurotech startup Synchron Inc. connected its brain implant to Apple’s Vision Pro headset, enabling patients with limited physical mobility to control the device using only their thoughts. Synchron is building an endovascular brain-computer interface designed to help patients with paralysis operate technology like smartphones and computers with their minds.

In Pumpkinseed Technologies Inc.’s first public patenting, the company’s co-founders describe their development of new proteomics platform that merges nanotechnology, biochemistry, silicon photonics and machine learning for high-resolution phenotyping to deliver new biological insights.

Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920.

Esperto Medical Inc. could soon offer a non-invasive method for blood pressure measurement for critically ill patients based on results seen in a study published in PNAS Nexus. Esperto’s Resonance Sonomanometry technology uses acoustic stimulation with ultrasound imaging to provide continuous, non-invasive readings.