Although many companies have experienced struggles during the COVID-19 pandemic, Brisbane, Australia, and Carlsbad, Calif.-based Impedimed Ltd. has seen success with Sozo, the company’s digital health platform. Indeed, the company has as one of its priorities helping patients with lymphedema with the platform, which is a noninvasive bioimpedance spectroscopy device.
Proscia Inc., a Philadelphia-based company that focuses on artificial intelligence (AI)-enabled digital pathology solutions, recently made the Concentriq Dx digital pathology software available for use in reviewing and reporting of digital pathology slides in the U.S. during the COVID-19 pandemic.
LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.
PARIS – Braintale SAS, of Paris, has gained CE mark approval for Brainquant. This software platform, which uses DICOM radiology imaging, enables diffusion MRI scans to be processed as part of managing patients in a coma following brain injury.
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.
As the cases of COVID-19 continue to mount around the world, hospitals and other providers are looking to virtual tools, apps and other products to help people check their symptoms and get advice on whether medical intervention is needed. To that end, Dublin-based Medtronic plc has launched two new tools to help clinicians assess, monitor and triage patients with respiratory symptoms and concerns about the coronavirus.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD).
Brisbane, Calif.-based Caption Health Inc. received good news from the U.S. FDA, which has given a thumbs up to Caption Guidance. This software aims to assist medical professionals in the acquisition of cardiac ultrasound images and uses artificial intelligence (AI) to provide real-time guidance.
IDbyDNA Inc., a San Francisco-based metagenomics technology company, scooped up $20 million in series B financing in a round led by Artis Ventures. Genesys Capital and others participated in the round. The company plans to use the money to accelerate uptake of its Explify software platform.
LONDON – Cognetivity Neurosciences Ltd. has received CE software as a medical device approval for its cognitive assessment tool, a five-minute test intended as a diagnostic aid to identifying the earliest stages of dementia.