Siemens Healthineers announced today that it received FDA 510(k) clearance for its MammoMat B.brilliant mammography platform. Clearance includes elements involving full-field digital mammography, or two-dimensional breast imaging, breast biopsy and titanium contrast-enhanced mammography. New features of the system enhance user ergonomics and workflow while reducing patient discomfort. Siemens Healthineers also submitted an FDA premarket approval […]
Software / IT
Smiths Medical warns on some infusion pumps
An urgent field safety notice issued in Europe warns of software issues with some CADD-Solis ambulatory infusion pumps made by Smiths Medical. The ICU Medical unit corrected some issues in previous software updates but some problems persist. For starters, according to the communication, the infusion pump may not alarm for an upstream occlusion. This issue […]
GE HealthCare adds Caption AI to handheld ultrasound
GE HealthCare announced today that it launched its Caption AI software for point-of-care assessments on its Vscan Air SL. Clinicians can now use the handheld ultrasound system with access to real-time, step-by-step guidance from Caption AI. It helps capture diagnostic-quality images and automated ejection fraction estimation to help inform clinical decisions across cardiac settings. GE […]
Karl Storz enters talks to acquire Asensus Surgical through letter of intent
Asensus Surgical (NYSE:ASXC) announced today that it entered into a non-binding letter of intent for Karl Storz to acquire it. The agreement enables Karl Storz to engage in diligence and negotiations over a potential acquisition of the surgical robot maker. Asensus and Karl Storz began a collaboration over surgical robotics just over a year ago […]
FDA clears Eko Health’s AI for heart failure detection
Eko Health announced today that the FDA cleared its Low EF (ejection fraction) detection AI platform for its digital stethoscope. Using an Eko stethoscope, providers can now detect Low EF — a heart failure indicator — in 15 seconds during a routine physical exam. Low EF AI embeds rapid, accessible low EF detection into a […]
Tandem Mobi automated insulin pump wins FDA nod for expanded pediatric use
Tandem Diabetes Care (Nasdaq:TNDM) announced that the FDA cleared its Mobi insulin pump for an expanded pediatric indication. The FDA approved Tandem’s 510(k) application for the use of Mobi in individuals two years of age and older. In an SEC filing dated April 1, the company said the decision came through on March 21. Previously, […]
FDA clears Baxter Novum IQ large-volume infusion pump, Dose IQ safety software
Baxter (NYSE:BAX) announced today that the FDA granted 510(k) clearance for its Novum IQ large-volume infusion pump (LVP) with Dose IQ safety software. Clearance adds the LVP to the Novum IQ platform, which already includes the Baxter syringe infusion pump (SYR). It enables clinicians to utilize a single, integrated system across a variety of patient […]
RefleXion inks AI partnership for cancer treatment planning
RefleXion Medical announced today that it signed a licensing agreement with Limbus AI to incorporate software into radiation treatment planning. The agreement enables the integration of the Limbus Contour automated contour software into the RefleXion X1 system. X1 uses biology-guided radiotherapy (BgRT) technology. It enables a PET radiotracer to create a unified motion management solution […]
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 […]
GE HealthCare unveils AI-enabled urology software
GE HealthCare announced today that it launched its Prostate Volume Assist (PVA) urology-based AI software feature. The company designed the software feature to support clinicians in prostate imaging, biopsies and guiding treatment. It assists urologists by improving workflows and quickly capturing prostate volume. The added functionality with PVA helps determine calculations and measurements of the […]