Skin cancer detection device maker DermaSensor filed a Form D with the SEC to confirm the sale of nearly $9 million in equity. According to the filing, dated Dec. 4, the first sale in the offering took place on Nov. 15. To date, the company reports just over $8.9 million raised in the offering seeking […]
Diagnostics
Withings picks up $22.5M investment for AI, medical device innovation
Withings announced today that it received approximately $22.5 million in investment and support for a new initiative from the French government. Through the France 2030 initiative, Withings is launching “Project Deep” (DEvice as a hEalth Prevention platform). The initiative aims to utilize cutting-edge AI and medical device innovation. It wants to advance the early detection and […]
FDA clears Movano smart ring’s pulse oximetry feature
Movano Health (Nasdaq:MOVE) announced today that it received FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring. Clearance enables Movano to pursue new opportunities for health monitoring solutions needed for applications like clinical trials, post-clinical trial management and remote patient monitoring for both healthcare providers and payors, the company said in a news […]
Philips, AWS expand strategic AI collaboration
Philips (NYSE:PHG) today announced the expansion of its strategic collaboration with Amazon Web Services (AWS). The collaboration offers Philips’ integrated diagnostics portfolio in the cloud. That includes radiology, digital pathology, cardiology and AI advanced visualization solutions. Philips and AWS aim to unify diagnostic workflows, improving access to critical insights and driving better outcomes across clinical […]
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 […]
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 […]
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 […]
Thermo Fisher to close Massachusetts plant, affecting 160 jobs
Thermo Fisher Scientific (NYSE:TMO) is closing a facility as part of a shift in operations across Massachusetts. The Boston Business Journal first reported the news last week. According to the state of Massachusetts’ Worker Adjustment and Retraining Notification program, the large medtech firm is enacting layoffs that affect 160 employees across three different locations in […]
Boston Scientific to acquire Cortex and its cardiac mapping tech
Boston Scientific (NYSE: BSX) announced today that it will purchase Ajax Health’s Cortex and its FDA-cleared OptiMap system to guide physicians performing ablation procedures to treat AFib Financial terms of the deal were not disclosed. Boston Scientific expects to complete the transaction in the first half of 2025, subject to customary closing conditions. “We believe […]
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
iRhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and labeling updates. San Francisco-based iRhythm submitted two updates to the mobile cardiac telemetry device following an FDA warning letter last year. The letter, made public shortly after the company’s announcement, accused iRhythm of violations related to rules for labeling, quality […]
