FDA Issues Draft Guidance for AI-Enabled Medical Devices: Key Recommendations and Updates
The U.S. Food and Drug Administration (FDA) released a draft guidance titled "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Man…
Tag: Artificial Intelligence
Allurion Launches in the US with its First AI-Native Compounded GLP-1 Program
AllurionMeds is designed to address a critical demand from patients: The Weight Must Stay Off Features Coach Iris, a first-of-its-kind conversational AI behavioral agent for weight loss and maintenance, trained using real-world experience in over 150,...
Revisto Raises $4 Million in Seed Funding to Revolutionize Pharmaceutical Marketing Compliance with AI
The Austin-based startup founded by industry leaders accelerates time to market, enhances efficiency, and reduces costs for pharmaceutical companies through AI-driven automation of medical, legal, and regulatory reviewsAUSTIN, Texas--(BUSINESS WIRE)--...
Axonal.AI Launches Industry-First Platform to Accelerate Life Sciences Speed to Market
Axonal's Agentic AI Collaborative Workspace leverages multi-agent technology to shorten the time from insights to actions and streamline commercialization.BOCA RATON, Fla.--(BUSINESS WIRE)--Axonal.AI today unveiled its groundbreaking platform, designe...
A Quantum Leap from Research to Diagnostic
At the close of Frontiers Health 2024, we had the pleasure of speaking with Luca Quagliata, VP and Global Head of Medical and Scientific Affairs from …
Onc.AI Serial Imaging Response Score Outperforms Traditional Methods for Early Assessment of NSCLC Immunotherapy Outcomes
Multi-institutional study presented at the SITC annual meeting highlights the ability of Onc.AI’s imaging-based biomarker to improve identification of long-term survivors at first follow up (HR 0.33). SAN CARLOS, Calif. & WATERLOO, Ontario--(BUSINESS ...
Advancing early diagnosis of Type 1 Diabetes in children with Machine Learning
In 2021, over 355,900 children worldwide were diagnosed with type 1 diabetes, a number expected to rise significantly by 2050. Early diagnosis is cruc…
EVERSANA Unveils TEDAVI, the Breakthrough Content Creation Hub to Transform Agency Marketing Models and Maximize Brand Impact
CHICAGO – Aug. 1, 2024 – EVERSANA, a leading provider of global commercial services to the life sciences industry, today introduced TEDAVI, the pharma…
Landmark Study Proves AI-Driven Mental Health Program is as Effective as Human Care
In Collaboration with the U.K. NHS, ieso Demonstrates Anxiety Symptom Reduction in 82 percent of Participants, with up to Eight Times Fewer Therapist Hours, to Catalyze U.S. Market EntryCAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--A new study by ieso...
Innovative AI solution enhances hair transplant surgery planning
LifeSemantics, a Korean player in digital health, is advancing medical AI research across various domains, including skin cancer diagnosis, blood pres…