FDA Archives - Page 45 of 78

GE HealthCare scores 510(k) clearance for maternal and fetal monitoring platform

February 5, 2024February 6, 2024MobiHealthNews

GE HealthCare received FDA 510(k) clearance for its Novii+ maternal and fetal monitoring solution, which will become available to U.S. customers later in the year.The device, consisting of a wearable and wireless sensor, enables…

Elephas raises $55m, Zeta Surgical received 510(k), Forta scores $55M, Vita Health receives $22.5M

February 2, 2024February 3, 2024BeKey

Welcome to the January edition of Digital Health Digest on our YouTube channel! Dive into the latest and most exciting advancements in digital healthcare, from cutting-edge diagnostic tools to innovative telehealth services. In this…

Demand for FDA Regulation in Healthcare Summarization

February 2, 2024February 2, 2024DistilINFO Hospital IT

Researchers from the University of Maryland School of Medicine warn that current FDA device-exemption criteria may allow large language models (LLMs) to produce unchecked clinical summaries, potentially influencing medical decisions and causing patient harm….

Radiology AI Marketplace CARPL Secures $6M to Bridge Radiologist Gap with Seamless Integration Tools

February 1, 2024February 2, 2024HIT Consultant

Dr. Vidur Mahajan, Founder/CEO at CARPL

What You Should Know:

– As healthcare demands rise with an aging population and growing emphasis on early disease detection, the burden on radiologists is reaching a critical point. To…

FDA medical device loophole could cause patient harm, study warns

February 1, 2024February 2, 2024Healthcare IT news

Doctors and researchers from the University of Maryland School of Medicine, the UMD Institute for Health Computing and the VA Maryland Healthcare System are concerned that large language models summarizing clinical data could meet…

23andMe Scores FDA Clearance for Novel Cancer Immunotherapy Targeting NK Cells

February 1, 2024February 1, 2024HIT Consultant

What You Should Know:

– 23andMe Holding Co. (Nasdaq: ME), a genetics and biopharmaceutical company, announced The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for 23ME-01473 (referred to…

Safeguards Needed for Generative AI EHR Data Summarization

January 31, 2024January 31, 2024EHR Intelligence

By Hannah Nelson

January 31, 2024 – While generative AI shows promise for EHR data summarization, using large language models (LLMs) to summarize clinical data brings risks that are not clearly covered by existing Food and…

Deliberate AI Joins FDA Pilot to Develop Mental Health Treatments

January 26, 2024January 27, 2024HIT Consultant

What You Should Know:

– Deliberate AI, a digital health company harnessing AI to revolutionize mental health assessment, has secured a major milestone in its mission. The U.S. Food and Drug Administration (FDA) has selected…

Siemens Healthineers Breaks Barriers with FDA-Cleared Virtual Cockpit

January 26, 2024January 26, 2024DistilINFO Hospital IT

Siemens Healthineers’ syngo Virtual Cockpit, the first FDA-cleared multi-vendor remote scanning software, redefines healthcare collaboration. With live audio, video, and chat functionalities, it supports up to three scanners simultaneously, addressing technologist shortages and standardizing…

Siemens Healthineers Overcomes Boundaries with Approved Virtual Cockpit

January 26, 2024January 30, 2024DistilINFO Hospital IT

Diverging trajectories of trust in healthcare and on-line information seeking: what’s next with LLMs

Weekly Roundup – January 31, 2026

Embedding clinical intelligence to help close care gaps

Impact of Mobilization Facilitated by Wearable Device Enhanced Patient Monitoring/Electrophysiology Pod–Based Feedback on Postoperative Complications Following Colorectal Cancer Surgery: Randomized Controlled Trial

Tag: FDA

GE HealthCare scores 510(k) clearance for maternal and fetal monitoring platform

Elephas raises $55m, Zeta Surgical received 510(k), Forta scores $55M, Vita Health receives $22.5M

Demand for FDA Regulation in Healthcare Summarization

Radiology AI Marketplace CARPL Secures $6M to Bridge Radiologist Gap with Seamless Integration Tools

FDA medical device loophole could cause patient harm, study warns

23andMe Scores FDA Clearance for Novel Cancer Immunotherapy Targeting NK Cells

Safeguards Needed for Generative AI EHR Data Summarization

Deliberate AI Joins FDA Pilot to Develop Mental Health Treatments

Siemens Healthineers Breaks Barriers with FDA-Cleared Virtual Cockpit

Siemens Healthineers Overcomes Boundaries with Approved Virtual Cockpit

Diverging trajectories of trust in healthcare and on-line information seeking: what’s next with LLMs

What impact has healow had on your organization and the patients’ experience?

Weekly Roundup – January 31, 2026

Embedding clinical intelligence to help close care gaps

Impact of Mobilization Facilitated by Wearable Device Enhanced Patient Monitoring/Electrophysiology Pod–Based Feedback on Postoperative Complications Following Colorectal Cancer Surgery: Randomized Controlled Trial

Meditech founder Neil Pappalardo dies at 83

The Landscape of Mobile Apps for Healthy Eating: Case Study for a Systematic Review and Quality Assessment

Decagon raises $250M for AI agents, triples valuation to $4.5B

Successful AI adoption requires meaningful change management

The Safe AI in Medicaid Alliance can help providers hone their tactics

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