Greenlight Guru announced that it has received a roughly $120 million investment from JMI Equity to support further development and sales growth for its medical device quality management software. The news comes half a year after Indianapolis-based Greenlight Guru launched its AI-powered Halo for Change Management, which provides recommendations of items impacted by a change […]
Software / IT
FDA rejects Verily’s smartwatch-based Parkinson’s exam
The FDA issued a letter to Google’s (NSDQ:GOOGL) Verily declaring that it will not accept a letter of intent for the company’s Parkinson’s exam. Verily submitted the LOI for drug development tool (DDT) for the virtual motor exam for Parkinson’s disease. The device measures a change in digitally assessed parameters of a subset of Parkinson’s disease […]
Getinge adds AI to its OR management software
Getinge announced today that it launched the Torin AI-based operation room management system in the U.S. Sweden-based Getinge’s Torin software uses AI to quickly and seamlessly improve the speed and efficiency of scheduling surgical procedures. The platform launched in 2020. The company today introduced a new suite of advanced functions for the platform, expanding its […]
Smart clothes powered by AI could monitor health
Purdue University engineers are touting a method for turning cloth items into battery-free, wearable and wireless “smart clothes.” The engineers at the West Lafayette, Ind.–based university developed a new spray/sewing method designed to transform any conventional cloth item into these smart clothes that can also be cleaned in the washing machine like normal clothing. Get […]
BD is upping its game on cybersecurity
BD (NYSE: BDX) is touting that it is the first medical technology company authorized as a Common Vulnerability and Exposures (CVE) Numbering Authority by the CVE Program. BD officials say the authorization further boosts the company’s healthcare cybersecurity leadership. Get the full story on our sister site Medical Design & Outsourcing.
Avicenna.AI’s triage system get regulatory nods
Avicenna.AI announced today that it received FDA 510(k) clearance and CE mark for its Cina Chest vascular condition triage system. Marseille, France-based Avicenna.AI designed Cina Chest to leverage deep learning algorithms to offer automatic detection and triage capabilities for both pulmonary embolism (PE) and aortic dissection (AD) from CT-scan imaging, according to a news release. […]
FDA authorizes Cognoa autism spectrum disorder diagnostic aid
U.S. FDA today authorized Cognoa’s machine learning-based software to help diagnose autism spectrum disorder. The de novo authorization from FDA covers the use of the Cognoa ASD Diagnosis Aid with children 18 months through 5 years of age with potential ASD symptoms. Palo Alto, Calif.–based Cognoa has touted the software as a way to do away […]
Edwards’ low-BP prediction software gains FDA clearance
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 […]
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 […]
