The U.S. FDA granted 510(k) clearance for Clew Medical Ltd.’s artificial intelligence (AI)-based solution that can predict hemodynamic instability in ICU patients eight hours in advance of deterioration. The system continuously monitors and stratifies patients by risk level to enable optimization of ICU resources.
Novasignal Corp. has a launched a cloud-based app to provide alerts to clinicians directly from its cerebral ultrasound device. The new app allows physicians to get instant notifications from the company’s Novaguide device, a transcranial doppler ultrasound technology that allows for real-time assessment of blood flow in the brain by combining robotics and artificial intelligence (AI).
HONG KONG – Earlysense Ltd. has sold a contact-free continuous monitoring technology to global med-tech provider Hillrom Holdings Inc. Ramat Gan, Israel-based Earlysense will receive licensing for all intellectual property and technology sold to Chicago-based Hillrom for use outside the hospital along with $30 million in cash, commercial milestone payments and a portion of Hillrom's equity investment
PERTH, Australia – Wellington, New Zealand-headquartered Volpara Health Technologies Ltd. has acquired Boston-based CRA Health LLC for $18 million up front and an additional $4 million to be paid over the next 18 months in earnouts. Volpara’s digital health solutions use imaging and artificial intelligence (AI) for early detection of breast cancer. The company’s clinical functions for screening clinics provide feedback on breast density, compression, dose, and quality, while its enterprise-wide practice software management helps with productivity, compliance, reimbursement and patient tracking.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: B-Secur, Claronav Kolahi, RapidAI, Precision Biomonitoring, Precision Spine.
Biosig Technologies Inc. and the Mayo Foundation for Medical Education and Research are jointly developing next-generation artificial intelligence (AI)-powered software for Biosig’s Pure EP electrocardiograph system. The Pure EP system acquires, measures, calculates and stores electrocardiographic and intracardiac signals for patients during electrophysiology procedures. The collaboration aims to expand the captured signals and combine them with other data sources to provide more actionable information.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clew, Pulse Biosciences.
BERLIN – The German government has just made $3.6 billion available to the Future of Hospitals Act (Krankenhauszukunftsgesetz, KHZG), through the liquidity reserve of the health fund in order to support public hospitals with digital transformation. Besides this government cash injection, an additional $1.6 billion will be made available through co-funding by the German federal states, the 16 Länder. In total, German hospitals will get a $5.2 billion funding to boost digitization.
The expansions of coverage of telehealth associated with the COVID-19 pandemic will persist after the pandemic is over, even if the post-pandemic utilization does not match the current rates and types of utilization. However, speakers on a recent webinar hosted by Moses & Singer LLP of New York said that state medical licensure practices after the pandemic could be a help or a hindrance to more widespread use of telehealth, an issue stakeholders will want to track as 2021 unwinds.
LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation.