Dexcom (Nasdaq:DXCM) today announced a significant investment and health monitoring partnership involving its CGM technology. Our sister site, Drug Delivery Business News, reports today that the San Diego-based continuous glucose monitor maker invested $75 million in Oura, maker of the Oura Ring, a smart ring that delivers vital sign, sleep, stress, heart health and activity […]
Software / IT
Augmedics picks up FDA nod for new CT-Fluoro registration
Augmedics announced today that the FDA cleared the CT-to-fluoroscopy (CT-Fluoro) registration method for its Xvision Spine System. The Xvision Spine System uses augmented reality to give surgeons “X-ray vision” during surgery. It launched new, FDA-cleared features and indications for the system in March. This latest addition enables surgeons to navigate off a preoperative CT scan and […]
BrightHeart earns FDA clearance for AI-powered prenatal heart ultrasound tech
BrightHeart announced today that it received FDA 510(k) clearance for its first AI software for prenatal ultrasound evaluations of the fetal heart. Paris-based BrightHeart designed its AI to address the challenges of detecting congenital heart defects (CHDs) in newborns. The company says misdetection or delayed diagnosis often leads to severe consequences, including missed opportunities for […]
Stryker rolls out next-gen SurgiCount+ hospital workflow tech
Stryker (NYSE:SYK) today announced the launch of the next generation of SurgiCount+ within its sponge management portfolio. The new SurgiCount+ offering integrates with Stryker’s Triton technology to address retained surgical sponges and blood loss assessment. According to a news release, integrating these previously separate digital solutions deliver a more efficient, streamlined hospital workflow. Portage, Michigan-based […]
Eko picks up reimbursement win for AI heart disease detection platform
Eko Health announced today that the American Medical Association issued a Category III CPT code for its Sensora platform. The newly issued CPT code goes into effect on July 1, 2025. San Francisco-based Eko said it marks the first step to coverage and reimbursement for Sensora, an AI-powered heart disease detection platform. Eko utilizes its […]
FDA clears outpatient cardiac telemetry for SmartCardia ECG patch
SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG platform. The clearance comes for the company’s seven-lead live ECG montoring patch and cloud platform. SmartCardia designed its easy-to-wear, cable-free, waterproof patch for up to 14 days of continuous monitoring. The Lausanne, Switzerland-based company already has FDA clearance […]
GE HealthCare wins FDA nod for new head-only MRI system
GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Signa Magnus MRI scanner. The 3.0T high-performance, head-only scanner offers new capabilities for both clinical imaging and neuroscience. It has the potential to aid in the detection of neurological, oncological and psychiatric conditions, according to a news release. Signa Magnus features what […]
FDA clears AI-powered breast cancer detection tech from iCad
iCad (Nasdaq:ICAD) announced today that the FDA cleared its ProFound Detection version 4.0 for digital breast tomosynthesis (DBT). Nashua, New Hampshire-based iCad trained its next-generation AI solution using deep learning convolutional neural networks (CNN). It offers advancements in cancer detection and specificity, improving the identification of hard-to-find and aggressive cancers. The technology also reduces false […]
Magstim earns FDA clearance for transcranial magnetic stimulation that treats depression, OCD
Magstim announced today that the FDA cleared its next-generation Horizon Inspire system for delivering transcranial magnetic stimulation (TMS). Clearance paves the way for the use of the TMS technology to treat patients with major depressive disorder (MDD), obsessive-compulsive disorder (OCD) and anxious depression. Minneapolis-based Magstim designed Horizon Inspire to address physician needs with high-power air […]
Nevro wins CE mark for HFX iQ spinal cord stim for pain relief
Nevro (NYSE:NVRO) announced today that it received CE mark in Europe for its HFX iQ spinal cord stimulation (SCS) system. HFX iQ utilizes AI, high-frequency (10 kHz) therapy and ongoing cloud insights to deliver personalized pain relief. It features an implantable pulse generator (IPG), trial stimulator and application. It includes a new, Bluetooth-enabled IPG, that […]
Johnson & Johnson wins FDA IDE for Ottava surgical robot
Johnson & Johnson MedTech announced today that the FDA granted its Ottava surgical robot investigational device exemption (IDE). The regulatory nod comes just under a month after the company announced that it submitted Ottava for IDE. It allows Johnson & Johnson MedTech to begin a clinical trial for the much-anticipated robotic platform at U.S. sites. […]
