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.

Urinary tract infections (UTIs) are a common reason for women to visit their doctor. While virtual doctor visits have been possible to detect UTIs, patient-reported symptoms typically have drove diagnoses. Now, Los Angeles-based Scanwell Health is bringing its at-home smartphone-enabled test and treatment service for UTIs to all 50 states. Scanwell said its offering its the first U.S. FDA-cleared urine testing app available over-the-counter without a prescription.

A neuropsychologist consult is typically the first step for a neurologist in aiding in the diagnosis and monitoring of neurological conditions. But timely appointments for an assessment by these specialists can be difficult to obtain, even under the best of circumstances. To better enable neurologists to assess which patients are most in need of a consultation with a neuropsychologist, Royal Philips NV has launched an artificial intelligence (AI)-based cognitive assessment tool in the U.S. Known as Philips Intellispace Cognition, the digital, cloud-based assessment tool takes established neuropsychological tests and enables their administration by a medical assistant via a tablet in an office setting.

Marlborough, Mass.-based Hologic Inc. got good news from the U.S. FDA, which has given the green light for the 3Dquorum imaging technology, which employs Genius AI. The technology works along with Hologic's Clarity HD high-resolution imaging technology to reduce tomosynthesis image volume for radiologists by 66%, the company said.

SAN JOSE, Costa Rica – Cross reality (XR) technology is gaining traction in the med-tech sector thanks to advancements in the virtual reality (VR), augmented reality (AR) and mixed reality (MR) fields that comprise it, triggered by a surge of investments that have driven cash flow to med-tech startups. The new technology is already impacting the health care sector.

Virta Health Corp. reported 90-day data from a pilot study of its Virta Treatment for type 2 diabetes (T2D) in military veterans. Conducted jointly by Virta and the U.S. Department of Veterans Affairs (VA), the pilot shows 84% of participants who used the low carbohydrate and diabetes coaching model reduced their glycemic levels to below the diabetes threshold or experienced at least a one-point drop in HbA1c, a measure of blood sugar.