What You Should Know:
- GE HealthCare announced today that its MIM Software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a groundbreaking tool in the fight against Alzheimer's disease.
- The advancement allows MIMneuro, a vendor-neutral software solution, to perform "Centiloid scaling" for analyzing and quantifying amyloid plaque density in the brain using positron emission tomography (PET) imaging.
Impact of Alzheimer's
Read More
FDA Clearance
Withings Sleep Rx Receives FDA Clearance for Home Sleep Apnea Testing
What You Should Know:
- Withings, a global leader in connected health, has announced that its Sleep Rx sleep apnea device has received clearance from the U.S. Food and Drug Administration (FDA).
- Sleep Rx represents a significant advancement in the diagnosis of sleep apnea, offering a more convenient and accurate alternative to traditional in-lab testing.
Addressing the Underdiagnosis of Sleep Apnea
Sleep apnea is a serious condition that affects millions of people
Read More
Qure.ai Receives FDA Clearance for AI-Powered Lung Nodule Analysis Tool
What You Should Know:
- Qure.ai, a global innovator in medical imaging AI, has today announced a pivotal 510(k) FDA clearance for its AI-powered chest CT solution – qCT LN Quant.
- The new AI solution is now available to support radiologists and pulmonologists in analyzing lung nodules on non-contrast chest CT scans and tracking volumetric growth as part of progression monitoring.
Qure.ai Enhances Lung Cancer Care with AI-Powered qCT LN Quant
Qure.ai has integrated qCT LN Quant into
Read More
AISAP’s AI-Powered Cardiac Ultrasound Receives FDA Clearance
What You Should Know:
- AISAP, a medical technology company specializing in AI-powered point-of-care assisted diagnosis (POCAD) solutions, announced today that it has received FDA 510(k) clearance for its groundbreaking CARDIO software platform.
- AISAP CARDIO is a cloud-based software package that combines four computer-assisted diagnosis (CADx) modules for valvular pathologies and eight key measurements into a single, user-friendly platform.
Point-of-Care
Read More
Diality Receives FDA Clearance for Innovative Hemodialysis System
What You Should Know:
- Diality, a medical device company focused on advancing kidney care, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Moda-flx Hemodialysis System™.
- The Moda-flx Hemodialysis System is designed to enhance the dialysis experience for both patients and healthcare providers. With its variable flow rate ranges, integrated reverse osmosis water filtration, and user-friendly interface, clinicians
Read More
TytoCare Awarded FDA Clearance for AI Lung Sound Analysis
What You Should Know:
- TytoCare, a virtual care company enabling accessible, high-quality primary care from home, announced today that it has received an additional FDA clearance for a new AI-powered diagnostic capability, Tyto Insights for Crackle Detection.
- This capability, which is built on TytoCare’s database of lung sound recordings and driven by an innovative, AI-based algorithm, joins TytoCare’s existing suite of diagnostic tools, including
Read More
Philips IntelliSite Pathology Solution Receives 510(k) Clearance
What You Should Know:
- Philips IntelliSite Pathology 5.1 has received 510(k) clearance from the FDA, solidifying its position as the most widely deployed digital pathology solution for primary diagnosis globally.
- With over 300 pathology labs already implementing Philips' solution, and over 20 labs achieving complete digital workflows, the success of this technology is evident.
Investing in the Future of Cancer Care
By empowering collaboration, boosting efficiency, and
Read More
FDA Clears AliveCor’s Heart Attack-Detecting AI Kardia 12L ECG System
What You Should Know:
- AliveCor, a leader in AI-powered cardiology, has received FDA clearance and launched a groundbreaking innovation – the Kardia™ 12L ECG System with KAI™ 12L AI technology.
- AliveCor's Kardia 12L ECG System signifies a major advancement in cardiac diagnostics. By combining cutting-edge AI technology with a portable and user-friendly design, the system empowers healthcare professionals to deliver faster, more accurate, and more accessible cardiac
Read More
Implicity Launches FDA-approved Heart Failure Prediction Algorithm, SignalHF
What You Should Know:
- Implicity, a leader in remote patient monitoring and cardiac data management, has received FDA 510(k) clearance for SignalHF1, a groundbreaking new algorithm within their remote monitoring solution.
- SignalHF1 algorithm empowers early detection and intervention, paving the way for improved patient outcomes and a brighter future for cardiac care.
Leveraging Big Data for Better Heart Care
Implicity holds a unique distinction as the first private
Read More
CLEW Medical Scores FDA Clearance for Next-Gen AI-Powered Patient Deterioration Prediction
What You Should Know:
- CLEW Medical, a provider of AI-driven clinical surveillance and predictive analytics, has achieved a breakthrough with FDA 510(k) clearance for its second-generation AI models for predicting patient deterioration.
- The FDA clearance builds upon their pioneering achievement of being the first FDA-cleared Class II medical device for this purpose in 2021.
Rigorous Testing for FDA Approval
Obtaining FDA clearance signifies that CLEW's AI models have
Read More
