The U.S. FDA has engaged in an overhaul of its software policies in the wake of the mandates spelled out by the 21st Century Cures Act. However, those policies are still a work in progress, as a recent FDA webinar made clear. The FDA won’t have long to put those policies into place as the U.S. House of Representatives is considering a follow-on to the Cures Act, dubbed Cures 2.0, which will impose yet more changes on the agency’s approach to software regulation.

Radiologist burnout is a common problem. To combat this issue, Berkeley, Calif.-based Rad AI has launched with a $4 million seed round led by Gradient Ventures, Google's AI-focused venture fund. Other participants in the round were UP2398, Precursor Ventures, GMO Venture Partners, Array Ventures, Hike Ventures, Fifty Years VC and various angels.

LONDON – Mologic Ltd. has started recruitment in a 263-patient trial to validate its urine-based home test for anticipating exacerbations of chronic pulmonary obstructive disease (COPD). The lateral flow immunoassay self-test detects five biomarkers of the lung disease in urine that are indicative of inflammation and infection.

Germantown, Md.-based Senseonics Inc. said results from a recent study confirm that the sensor in its Eversense continuous glucose monitoring (CGM) system performs well over multiple, sequential 90-day and 180-day cycles. The real-world trial assessed the accuracy of the Eversense data management system by comparing sensor blood sugar values with self-monitored glucose values in 945 adults.

Stanford University School of Medicine and Apple Inc.have published results from the largest digital-only study. The trial has been conducted in more than 400,000 people in the U.S. over more than eight months. It was set up to screen participants via their Apple Watch for heart irregularities and then to further monitor any of those with identified issues with a wearable ECG patch.

LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new rules. The vast majority of software products that are treated as class I under the current rules – and therefore self-certified – will be upgraded to class IIa and higher under the Medical Devices Regulation (MDR) coming into effect in May 2020, and the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022.

Oxford University startup Ultromics Ltd. has won the U.S. FDA's nod for its artificial intelligence (AI) image analysis system for diagnosing coronary artery disease. Called Echogo Core, the system is intended to serve as an aid to cardiologists in evaluating echocardiograms of patients referred with symptoms such as shortness of breath and chest pain. Ross Upton, co-founder and CEO of Ultromics, called the clearance a "watershed moment" for the company, which began developing its algorithm-based system in 2011 and was spun out of Oxford University in 2017. The next stage for the company is commercializing the product and bringing it to clinicians in the U.S. Ross said the company expects to launch the product in the beginning of next year.