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FDA

FDA Announces Clearance for AI-Based Imaging Platform

The FDA granted 510(k) clearance for the Accuro 3S diagnostic ultrasound system and SpineNav-AI image processing ...

AUGUST 25, 2025

FDA Awards Expanded Parameters for Masimo’s O3 Oximetry Device

The product is now able to be used in cerebral and somatic applications for all patient populations. 

AUGUST 19, 2025

FDA Approves Ketamine for Surgical Pain Management

THe FDA has approved a new ketamine product for surgical pain management.

AUGUST 18, 2025

Smiths Medical Issues Urgent Recall for Intubation Endotracheal Tubes Due to Sizing Problem

Smiths Medical has notified the FDA of a sizing issue with its Intubation Oral/Nasal Endotracheal Tubes.

MARCH 18, 2025

Expanded FDA Approval of Fibryga Covers Acquired Fibrinogen Deficiency

The approval of fibrinogen (human) lyophilized powder for reconstitution (Fibryga, Octapharma) has been extended by ...

AUGUST 8, 2024

FDA Addresses Skin Tone Disparities With Pulse Oximeters

The FDA recently convened a public meeting in an effort to address ongoing efficiency concerns with pulse oximeters ...

APRIL 2, 2024

FDA Issues a Critical Safety Communication on Syringes Manufactured in China

A series of events could lead up to a supply chain disruption of one of our most critical medical devices.

JANUARY 4, 2024

Severe Euglycemic Diabetic Ketoacidosis Associated With SGLT2 Inhibitor

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are one of the newest classes of oral diabetes medications.

NOVEMBER 9, 2023

Antidepressants for Chronic Pain: Use Ubiquitous but Largely Unsubstantiated

Antidepressants are used in the management of chronic pain despite insufficient evidence of long-term efficacy, ...

SEPTEMBER 22, 2023

Proper Disposal of Unused Opioids Is Point of Leverage in Ending Overdose Crisis

The Center for Drug Evaluation and Research announced a new collaboration to encourage the proper disposal of ...

AUGUST 31, 2023

Ending the Opioid Crisis: Are the Tools Within Reach?

According to the latest data from the CDC, a record 108,279 Americans lost their lives to drug overdoses between ...

JUNE 29, 2023

Current Concepts In the Management of The Difficult Airway

This edition of “Current Concepts in the Management of the Difficult Airway” marks the 20th anniversary ...

JUNE 13, 2023

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