Edwards Lifesciences (NYSE:EW) has announced that its Acumen hypotension prediction index (HPI) software has received FDA 510(k) clearance. Using data obtained from the Acumen IQ finger cuff, the software uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only […]
Health Technology
iRhythm CEO Mike Coyle steps down for personal reasons, stock slides
iRhythm Technologies (NSDQ:IRTC) announced that president & CEO Mike Coyle has resigned due to personal matters. San Francisco-based iRhythm said in a news release yesterday evening that CFO Douglas Devine will take over as interim CEO while the search for a permanent replacement for Coyle is conducted. The company’s board of directors formed a CEO […]
Lucida Medical gains CE mark for cancer-detection software
Lucida Medical announced today that it received CE mark approval for its machine learning-based prostate cancer detection software. Cambridge, UK-based Lucida’s Prostate Intelligence (Pi) software offers a way for radiologists to assess and report MRI imaging studies and support the decision of whether or not to perform a biopsy, while also accurately targeting biopsies where […]
DarioHealth touts research on digital therapeutics for diabetes patients
DarioHealth (NSDQ:DRIO) announced today that recently published research supports its digital therapeutic platform for type 2 diabetes. New York-based DarioHealth published a new study through a letter to the editor in the Journal of Diabetes Science and Technology, according to a news release. The study observed participants using DarioHealth’s digital therapeutics for diabetes management, monitoring for both […]
Ibex AI-enabled breast cancer diagnostic lands CE mark
Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform. Tel Aviv, Israel–based Ibex’s Galen platform uses AI and machine learning technology based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology, according to a news release. Galen previously won CE […]
iRhythm wins FDA clearances for next-gen Zio monitor, AI capabilities
iRhythm Technologies (NSDQ:IRTC) announced that it received FDA 510(k) clearances for updates to its heart rhythm monitoring tech. San Francisco-based iRhythm’s first clearance came for a new and improved design of its flagship wearable Zio monitor and the second covered updated artificial intelligence (AI) capabilities, according to a news release. The Zio ambulatory cardiac monitoring […]
Qardio inks EHR deal with Redox
Qardio said today that its remote patient monitoring tech, QardioMD, will work with any provider that uses Redox to exchange healthcare data. The partnership will enable remote care delivery and translate electronic health record (EHR) data into information for clinical decision-making, according to the companies. Get the full story on our sister site, Medical Design & Outsourcing.
ITC takes up AliveCore patent complaint against Apple
The U.S. International Trade Commission (ITC) has agreed to investigate if Apple has imported devices that infringe three patents held by AliveCor. AliveCor filed the ITC complaint in April, alleging that Apple violated U.S. tariff law by importing certain Apple watches that infringe patents for its ECG technology. Mountain View, Calif.-based AliveCor wants the trade commission […]
7 digital health startups you need to watch in 2021
Digital health has skyrocketed in recent years. The pandemic has only propelled its growth by keeping patients away from doctors’ offices in droves. Thanks to the continued adoption of smartphones, the growth of connected medical devices and changes in patients’ and providers’ preferences, digital health will only continue to expand through the 2020s and beyond, […]
Apple debuts software for people with disabilities
Apple yesterday unveiled next-generation software features designed for people with mobility, vision, hearing and cognitive disabilities. Cupertino, Calif.-based Apple’s operating systems are set to undergo software updates later this year that would allow people with limb differences to navigate the Apple Watch using AssistiveTouch, while the iPad will support third-party eye-tracking hardware for easier control and […]
Emergo by UL, MedCrypt pair on cybersecurity
Emergo by UL and MedCrypt will jointly offer cybersecurity risk management and mitigation for connected medical devices and systems. Medtech and healthcare technology consulting group Emergo and healthcare cybersecurity developer MedCrypt said this week that they will refer prospective clients to one another and co-market their cybersecurity software solutions, consulting and risk management services to ensure clients understand […]