JD Supra4h
JPM2025: Regulation of artificial intelligence: Navigating a new frontier in health care
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...
Nanoleaf is jumping into beauty tech with a $150 face mask
The Nanoleaf LED Light Therapy Face Mask is made of medical-grade materials and has received FDA Class II device ...
RTE Online6h
Med-tech firm Fire1 secures $120m in new financing
Dublin-based medical technology company Fire1 has raised $120m in new financing. The company, led by Conor Hanley, aims to ...
aha.org32m
FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
FDA recommends fixing racial disparities in pulse oximeter readings
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...
MedPage Today6h
FDA Unveils Draft Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones
The FDA recommendations apply to only professional oximeters used in hospitals, doctor's offices, and other medical settings.
MassDevice9h
Alleviant Medical wins FDA IDE, breakthrough nods for no-implant heart failure treatment
Alleviant Medical announced that it received FDA investigational device exemption and breakthrough device designation for its ...
Scripps News on MSN4h
FDA calling on pulse oximeter makers to make life-saving changes to devices
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
JD Supra6h
AI-Enabled Device Software Functions: FDA’s Final Guidance for Predetermined Change Control Plans
On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) ...
medtechdive4h
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
The Business Journals17h
The Business Journals News
© 2025 American City Business Journals. All rights reserved. Use of and/or registration on any portion of this site constitutes acceptance of our User Agreement ...