Anumana announced that it received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device. Cambridge, Massachusetts–based Anumana, an Nference portfolio company, worked in collaboration with Mayo Clinic. They designed the breakthrough medical device to detect low ejection fraction (LEF) in patients at risk of heart failure. The company’s pulmonary hypertension (PH) early detection algorithm […]
Big Data
Asensus, Nvidia to collab on AI for surgical robotics
Asensus Surgical (NYSE:ASXC) announced today that it entered into a collaboration with Nvidia to accelerate the development of its ISU. The partnership aims to enhance the ISU (Intelligent Surgical Unit), part of Asensus’ performance-guided surgery offerings. Asensus designed its flagship Senhance surgical robot platform around the ISU. The real-time intraoperative surgical image analytics platform leverages […]
Eko Health partners with FIGS to expand its digital stethoscope’s reach
Healthcare apparel company FIGS and digital health tech outfit Eko Health today announced the U.S. launch of the FIGS | Eko Core 500 digital stethoscope. As with the initial edition of the Core 500 launched in June after FDA clearance a month before, the product combines Eko’s TrueSound sound filtering and noise reduction technology with […]
Lawsuit alleges ‘potentially problematic’ patient data sharing from Medtronic Diabetes devices
A class-action lawsuit filed against Medtronic alleges that the company’s insulin delivery devices shared patient data with third parties. The lawsuit — filed by the plaintiff “A.H.” in U.S. District Court in Central California — levels allegations against Medtronic and its MiniMed and InPen devices. It addresses MiniMed’s transmission and disclosure of personally identifiable information […]
FDA clears new infusion pump and software from ICU Medical
ICU Medical announced today that the FDA granted 510(k) clearance to its Plum Duo infusion pump with LifeShield infusion safety software. The San Clemente, California-based company plans to make the pump and software available to U.S. customers in early 2024. Plum Duo, the latest addition to the ICU Medical infusion device portfolio, builds on the […]
GE HealthCare launches digital support tool for AFib
GE HealthCare announced today that it launched its CardioVisio digital tool for helping to treat AFib. CardioVisio assists clinicians in visualizing longitudinal data relevant for disease progression from multiple data sources. It drives evidence-based clinical decision support directed by up-to-date AFib guidelines. GE HealthCare plans to showcase the technology at the European Society of Cardiology […]
FDA grants de novo nod to hypertrophic cardiomyopathy AI algorithm from Viz.ai
Viz.ai announced today that the FDA granted de novo approval to its Viz HCM module for detecting hypertrophic cardiomyopathy. San Francisco-based Viz.ai says this creates a new regulatory category for cardiovascular machine learning-based notification software. The company supports its algorithm’s deployment through a multi-year agreement with Bristol Myers Squibb. They struck that partnership deal in […]
Philips inks in-house virtual care collaboration with CoxHealth
Philips announced today that it entered into a virtual care collaboration with CoxHealth. CoxHealth, a U.S. not-for-profit healthcare provider, sought out Philips to implement virtual care through its hospital network. The company wanted a solution staffed entirely by its own employees that expanded beyond the intensive care unit. It also hoped for something that allowed […]
Eitan Medical launches cloud-based infusion management platform
Drug delivery technology developer Eitan Medical announced today that it launched the Eitan Insights cloud-based infusion management system. Netanya, Israel-based Eitan Medical designed Eitan Insights to meet the unique needs of at-home and specialty infusions. The company’s infusion systems, Sapphire, and Avoset, connect and transmit infusion data to the platform. Sapphire now features a plug-and-play […]
The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions
As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space. At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for […]
CISA warns on cybersecurity vulnerability for Medtronic cardiac device data workflow system
The U.S. Cybersecurity and Infrastructure Security Agency (CISA) issued a warning on the Medtronic cardiac device data workflow system. This vulnerability affects Paceart Optima systems, versions 1.11 and prior. CISA lists the vulnerability as the deserialization of untrusted data, “exploitable remotely” with “low attack complexity.” The agency says successful exploitation could result in a remote […]