News Service

late-breaking news in healthcare

FDA News Briefs for Monday, September 24, 2018

September 24, 2018 News Service

These Food and Drug Administration (FDA) developments recently came in.

FDA Approves ReCell Device for Treatment of Severe Burns

September 21, 2018 News Service

Avita Medical has announced that the Food and Drug Administration (FDA) approved the ReCell Autologous Cell Harvesting Device for the treatment of severe thermal burns in patients aged 18 years and older.

FDA News Briefs for Wednesday, September 19, 2018

September 19, 2018 News Service

These Food and Drug Administration (FDA) developments came in this week.

FDA News Briefs for Monday, September 17, 2018

September 17, 2018 News Service

These Food and Drug Administration (FDA) developments came in late last week.

FDA Approves Lumoxiti for Treatment of Hairy Cell Leukemia

September 14, 2018 News Service

The Food and Drug Administration (FDA) has approved Lumoxiti (moxetumomab pasudotox-tdfk; AstraZeneca Pharmaceuticals) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL).

FDA Grants Marketing Clearance for Apple Watch Arrhythmia Detection App

September 13, 2018 News Service

The Food and Drug Administration (FDA) has granted a de novo classification order for an irregular rhythm detection feature for the Apple Watch.

FDA Safety Alerts

September 12, 2018 News Service

The Food and Drug Administration (FDA) has issued the following safety alerts.

USPSTF: Screen All Pregnant Women for Syphilis as Early as Possible

September 10, 2018 News Service

On September 4, 2018, the U.S. Preventive Services Task Force (USPSTF) released a final recommendation statement and evidence summary on screening for syphilis in pregnant women.

Class I Recall: Tri-Flo Subglottic Suction Systems

September 7, 2018 News Service

Vyaire Medical Inc. is recalling its Tri-Flo Subglottic Suction System because there is a risk that the distal soft tip of the catheter may break off and enter the patient's lungs. The Food and Drug Administration (FDA) has identified this action as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

FDA News Briefs for Wednesday, September 5, 2018

September 5, 2018 News Service

These Food and Drug Administration (FDA) developments came in late last week.