William Blair analyst Margaret Kaczor reported surprise at the increase in users of CGM within the non-insulin and basal insulin populations. Kaczor expects Dexcom and Abbott to benefit from the trend with their next-generation CGM offerings after meetings with both companies’ management. Both companies launched next-gen CGMs in recent years (Dexcom G7 and Abbott FreeStyle […]
Patient Monitoring
FDA clears Epitel remote monitoring tech, AI detection platform
Epitel announced today that it received FDA 510(k) clearance for two new patient-focused brain health offerings. The FDA cleared the Remi remote EEG monitoring system for ambulatory use and the Remi Vigilenz AI for event detection. Remi for ambulatory use allows for EEG recording in outpatient and home environments for an extended duration. Vigilenz AI […]
Allurion closes $48 million financing
Allurion (NYSE:ALUR) announced today that it closed a financing of convertible senior secured notes worth $48 million. The company entered into the financing with certain entities managed by RTW Investments. It intends to use proceeds to repay obligations under its existing term loan with Fortress Credit Corp. This reduces the company’s interest expense and increases […]
Raydiant Oximetry wins FDA IDE nod for fetal pulse oximeter
Raydiant Oximetry announced that the FDA granted investigational device exemption (IDE) to its Lumerah technology. IDE enables an early feasibility study evaluating the technology for pregnant women during labor and delivery. The company designed Lumerah to improve the detection of fetal distress during labor and delivery. A non-invasive, transabdominal fetal pulse oximeter, it measures the […]
Dexcom, MD Revolution partner to integrate CGM into remote care platform
MD Revolution today announced a partnership with Dexcom to integrate CGM into its remote care management platform. Dexcom develops continuous glucose monitoring technology (CGM), including its latest-generation G7. The system pairs with smartphones — and now Apple Watches — to monitor the glucose levels of people with diabetes. MD Revolution’s remote care management platform integrates […]
Biotronik unveils new AI-powered insertable cardiac monitor
Biotronik announced that it received CE mark approval and completed the first European implant of its latest insertable cardiac monitor (ICM). The BioMonitor IV features AI capabilities for false positive reduction. The AI cuts false positives for AFib, bradycardia, tachycardia and pause. According to Biotronik, its SmartECG reduces 86% of false detections across all major […]
Biolinq raises $58M to support intradermal glucose sensor
Biolinq announced today that it completed a $58 million financing to support the progression of its proprietary intradermal glucose sensor. Alpha Wave Ventures led the funding round. Niterra’s corporate venture capital fund jointly operated with Pegasus Tech Ventures also participated. Other contributors included existing investors RiverVest Venture Partners, AXA IM Alts, Global Health Investment Corporation, […]
Politan picks a new Masimo board fight, targeting CEO’s seat after recent wins
Masimo is fighting with Politan Capital Management again after the activist investor won a heated battle for two seats last year. Politan Managing Partner and Chief Investment Officer Quentin Koffey said his firm is nominating two more candidates for election to the board at this year’s annual meeting in a bid to take control of […]
FDA clears sleep monitoring software from Beacon Biosignals
Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring. SleepStageML automatically stages sleep from electroencephalogram (EEG) signals of clinical polysomnography (PSG) recordings. It aids in the diagnosis and evaluation of sleep and sleep-related disorders. Boston-based Beacon Biosignals said in a news release that the software could enable […]
Tandem Diabetes Care taps miniaturization and automation for its latest systems
Tandem Diabetes Care (Nasdaq:TNDM) EVP and Chief Strategy Officer Elizabeth Gasser didn’t exactly plan for the whirlwind past year or so. In the space of about two months, Tandem announced continuous glucose monitor (CGM) integration with the latest-generation technology from Dexcom and Abbott, launched its Tandem Source diabetes management platform and began the rollout of […]
Ypsomed sells pen needle, blood glucose monitor business to focus on insulin pump
Ypsomed announced today that it agreed to sell its pen needle and blood glucose monitoring (BGM) businesses to Medical Technology and Devices (MTD). With the transfer of these businesses, Ypsomed plans to focus its diabetes care business on insulin pumps. Specifically, it looks to the further development and marketing of the mylife Loop automated insulin […]