Nanobiotix SA ’s achieved promising early results in several clinical trials for its first-in-class radioenhancer. Despite the pandemic, trials in head and neck squamous cell cancer, hepatocellular carcinoma, pancreatic cancer, and rectal cancer remain on track, the Cambridge, Mass., and Paris-based company reported at ASTRO 2020.
Castle Biosciences Inc.'s Decisiondx Diffdx-Melanoma test is now commercially available to help dermatopathologists better characterize melanocytic lesions. About 15% of suspicious pigmented skin lesions cannot be definitively determined to be benign or malignant using common methods. The new gene expression profile test reduces the number of indeterminate results by more than 70%.
The U.S. FDA moved the goal posts for other companies with its expansion of the emergency use authorization for Helix Opco LLC’s COVID-19 test to include both unsupervised self-collection of samples and testing of asymptomatic individuals. The new indications promise to make the Helix test the preferred tool for schools, universities, and work settings by reducing costs and increasing flexibility.
Premarket approval by the U.S. FDA of a new venous stent system made by Medtronic plc could blast through impediments for patients who suffer from complex deep vein obstruction. Less than 1% of patients with iliofemoral venous outflow obstruction currently receive treatment, despite the risk of serious complications and sharply reduced quality of life. Approval of the Abre stent was based on a 200-patient clinical study.
A new tool for mobile devices can diagnose stroke as accurately as an emergency medicine specialist in just minutes, enabling patients to get brain-saving therapies in time for maximum benefit. According to researchers from Pennsylvania State University and Houston Methodist Hospital, the artificial intelligence (AI)-based tool could counterbalance physician biases, reducing both overuse of CT scans and underdiagnosis of mild and moderate stroke.
Bluestar Genomics Inc. identified DNA-based epigenomic changes that could be used as new biomarkers that can detect pancreatic cancer before the malignancy, one of the deadliest of all cancers, becomes untreatable. The study was published in Nature Communications.
The U.S. FDA cleared Ezra AI Inc.'s artificial intelligence (AI) system for prostate cancer and its cloud-based picture archiving and communication system (PACS) that enables radiologists to use the Prostate AI from their browser. The New York-based company’s Prostate AI is the first prostate-focused artificial intelligence system to gain clearance. The Prostate AI accurately quantifies prostate volume, lesion size, and renders 3D volumes of the prostate gland and lesions.
Butterfly Medical Ltd. could be on the verge of metamorphosis into a major player in the benign prostatic hyperplasia treatment field. The Yokneam, Israel-based company just raised $7 million in a series B financing led by New Rhein Healthcare Investors LLC, of Philadelphia.
Inari Medical Inc.'s Flowtriever device appears to offer a safer and more effective option for pulmonary embolisms than current treatment with thrombolytics or open embolectomy, according to prospective study presented at the TCT Connect 2020 conference.
Thermo Fisher Scientific Inc. launched a new cell therapy processing system that overcomes many of the hurdles that have kept promising cell therapies from reaching commercialization. The modular, closed system increases cell processing efficiency and reduces associated costs.
