FDA

Local Malaria Cases Prompt CDC Monitoring and Hypervigilance

by Veronica Salib

On June 26, 2023, the United States Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory prompted by local cases in Florida and Texas. The organization...

FDA Issues Warning on Raw Oysters Contaminated with Norovirus

by Veronica Salib

On June 16, 2023, the FDA issued a statement warning restaurants, retailers, and consumers to avoid serving, selling, or consuming raw oysters from Dai One Food Co, Ltd, and Central Fisheries Co, Ltd,...

SCOTUS Lifts Abortion Pill Restrictions Pending Final Ruling

by Veronica Salib

On April 14, 2023, an order by Samuel A. Alito, Jr., a judge for the United States Supreme Court (SCOTUS), issued an order that lifted restrictions on the abortion pill, pending a final ruling from the...

FDA Identifies Class I Recall on Philips CPAP and BiPAP Machines

by Veronica Salib

On April 7, 2023, the FDA identified a Class I recall on the Philips Respironics CPAP and BiPAP machines due to inaccurate or insufficient therapy. The devices, intended for treating sleep apnea, had a...

Wyoming Bans Medication Abortion, Limiting Access to Reproductive Care

by Veronica Salib

On Friday, March 17, 2023, Governor Mark Gordon signed an act prohibiting medication abortions in Wyoming. While Wyoming is already a red state with only one clinic providing abortions, this further...

FDA Requires Breast Density Information, New Mammography Regulations

by Veronica Salib

The newest FDA mammography regulations include requirements for sharing information on breast density, enforcing more extensive FDA oversight of mammography facilities, and adding more tools for...

Researchers Find Gadolinium Used in Medical Imaging Stays in Kidneys

by Hayden Schmidt

Gadolinium-based contrast agents, commonly used in medical imaging since the 1980s, have been shown to induce negative consequences in new research conducted at the University of New Mexico (UNM). A...

FDA Issues Emergency Use Authorization for COVID and Influenza Tests

by Veronica Salib

On February 24, 2023, the FDA issued a press release announcing an emergency use authorization (EUA) for at-home tests that detect influenza and COVID-19. This EUA allows over-the-counter sales of the...

12 States Sued the FDA to Ease Restrictions for Medication Abortion

by Veronica Salib

On February 24, 2023, 12 states filed a lawsuit against the FDA to ease restrictions enforced for mifepristone, one of two pills required for a medication abortion. This lawsuit addresses concerns that...

Governors Create Reproductive Freedom Alliance to Defend Access to Care

by Hayden Schmidt

To sustain the right to an abortion and other forms of reproductive care, democrat Governors from 20 states are pledging to create a nationwide ‘abortion firewall’ in the form of the...

Orchestra BioMed Goes Public After $110 Million PE Fund Raise

by Hayden Schmidt

Orchestra BioMed was introduced on the Nasdaq Global Market this month after completing its combination with the special purpose acquisition company Health Sciences Acquisitions Corporation 2. Gross...

ECRI Highlights Communication Gaps in Medical Device Recalls

by Veronica Salib

In a recent news release, the Emergency Care Research Institute (ECRI) highlighted gaps in communication regarding medical device recalls, noting that these gaps could be a significant threat to...

Blu Biotech to Collaborate on Sepsis Detection Device

by Veronica Salib

Sepsis, caused by untreated infection, is a life-threatening syndrome that is a common complication of many diseases and procedures. According to a press release by Blu Biotech, 48.9 million people...

77% of Females Favor Making Birth Control Pills Available OTC

by Veronica Salib

In a post-Roe world, healthcare professionals, public health experts, and industry leaders are looking to empower people to take charge of their reproductive health. With limited access to abortion...

FDA Issues Emergency Authorization for Roche’s Monkeypox Test

by Hayden Schmidt

The pharmaceutical company, Roche Holding AG, received emergency use authorization (EUA) from the FDA Tuesday for its cobas MPXV test that successfully detected monkeypox in human trials. The test is...

Philips’ New Artificial Intelligence-Enabled Medical Imaging Application

by Hayden Schmidt

Last week, Philips announced that it received FDA 510(k) clearance for its magnetic resonance for calculating attenuation (MRCAT) imaging and simulation applications. The company’s MRCAT Head and...

Over-the-Counter Hearing Aids Launched

by Veronica Salib

On October 17, 2022, Lucid Hearing officially launched its line of over-the-counter hearing aids. The launch follows an FDA ruling earlier this year that allowed for the over-the-counter sale of...

PET Scans Vary in Detection of Amyloid Plaques

by Veronica Salib

As the population in the United States continues to age, dementia and other neurodegenerative diseases have become an increasing concern. Diagnostic tools for Alzheimer’s disease are essential as...

FDA Approves New MRI Contrast Agent for Nervous System Imaging

by Hayden Schmidt

A new macrocyclic gadolinium-based contrast agent created by Bracco Diagnostics Inc. gained FDA approval last week after a positive Phase III study. The Vueway injection will be available for adult and...

New Remote Patient Monitoring Technology for Sleep Apnea Announced

by Veronica Salib

On September 13, 2022, Silent Night Therapy announced a new remote patient monitoring technology for sleep apnea. This technology could revolutionize sleep apnea testing, which currently requires...