HHS, FDA Want to Slash Health Care Rules in 10-to-1 Deregulation Plan
The agencies are asking stakeholders to weigh in on a sweeping deregulatory initiative that will eliminate 10 regulations for every one introduced.
Tag: FDA
All
Latest
All
Latest
AdvaMed Unveils AI Policy Roadmap to Guide Medtech Regulation and Innovation
New framework calls for clear regulatory pathways, data access reform, and reimbursement strategies to advance AI-enabled medical devices.
All
Latest
FDA Adds Hemodialysis Bloodlines to Medical Device Shortages List
The shortage is expected to impact patient care, prompting the FDA to recommend conservation strategies for health care providers.
All
Latest
HHS, FDA Want to Slash Health Care Rules in 10-to-1 Deregulation Plan
The agencies are asking stakeholders to weigh in on a sweeping deregulatory initiative that will eliminate 10 regulations for every one introduced.
FDA Adds AAMI Sterilization Guidance to Standards Database
FDA has recognized four AAMI sterilization documents in its Consensus Standards Database, including updated guidance on ethylene oxide usage.
Read More
Philips Alerts Customers to Missed Cardiac Telemetry Notifications
Philips’ cardiac telemetry Monitoring Service Application did not route some ECG events from July 2022 to July 2024 for cardiology review.
Read More
FDA Publishes Draft Guidance to Improve Pulse Oximeters
The FDA published new draft guidance targeting pulse oximeter accuracy disparities across diverse skin tones.
Read More
FDA Issues Draft Guidance for AI-Enabled Devices
The FDA released draft guidance outlining a comprehensive framework for AI-enabled devices throughout their life cycle.
Read More
Baxter Issues Alert to Solution Sets Users for Assembly Issue
Baxter is recalling certain Solution Sets with Duo-Vent Spikes due to an assembly issue that led to inverted slide clamps.
Read More
FDA OKs Inogen Simeox 200 Airway Clearance Device
The Inogen Simeox 200 Airway Clearance Device aids bronchial drainage in patients with chronic respiratory conditions using high-frequency oscillatory vibrations and intermittent negative pressure.
Read More
All
Latest
Interlynk Partners with MDM for FDA Cybersecurity Compliance
Interlynk’s SBOM Automation Platform helps healthcare organizations manage software risks, maintain transparency, and meet FDA guidelines.
