FDA

FDA Authorizes AI Sepsis Prediction, Detection Tool

April 5, 2024 - On April 3, 2024, the United States FDA granted Prenosis Inc. De Novo marketing authorization for Sepsis ImmunoScore. The tool is an artificial intelligence (AI) and machine learning (ML) software that can predict the risk of sepsis and aid in early diagnosis, allowing for prompt treatment. "FDA authorization of a sepsis diagnostic tool with...

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FDA approves Eko Health’s Low EF detection AI for detecting heart failure

by Alivia Kaylor

Eko Health, recognized for its utilization of artificial intelligence (AI) in the early detection of heart and lung conditions, has revealed that its Low EF (ejection fraction) detection AI, integrated...

FDA authorizes pre-exposure prophylaxis for COVID-19

by Veronica Salib

Invivyd was granted an Emergency Use Authorization by the United States FDA for PEMGARDA, a pre-exposure prophylaxis (PrEP) treatment for COVID-19. The administration is authorizing the therapy for...

FDA Approves Over-the-Counter Sale of Dexcom CGM

by Veronica Salib

On Tuesday, March 5, 2024, the United States FDA cleared the first over-the-counter continuous glucose monitor (CGM), the Dexcom Stelo Glucose Biosensor System. This new approval marks the first time...

FDA Expands Approval of CASGEVY for Beta Thalassemia

by Veronica Salib

On January 16, 2024, Vertex Pharmaceuticals and CRISPR Therapeutics secured yet another approval for CASGEVY, the first FDA-approved gene therapy in the United States. Last month, the companies’...

FDA Updates Medical Device Sterility Guidelines

by Veronica Salib

Earlier this week, on January 8, 2024, the United States FDA announced a revised version of its guidance on medical device sterility: Submission and Review of Sterility Information in Premarket...

Reckitt Recalls Nutramigen Infant Formula for Bacterial Contamination

by Veronica Salib

Closing out the year, Reckitt, which owns Mead Johnson Nutrition (MJN), voluntarily recalled six batches of Nutramigen Powder, an infant formula sold under the Enfamil brand, on December 31, 2023. The...

FDA Issues Draft Guidance for Using RWD in Medical Device Regulation

by Veronica Salib

On December 18, 2023, the United States Food and Drug Administration (FDA) published a draft guidance called “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical...

Abortion Rights on the Line Again as SCOTUS Hears Mifepristone Case

by Veronica Salib

On December 13, 2023, the Supreme Court of the United States (SCOTUS) agreed to review an August case whose appeals court decision restricted access to mifepristone, one of the two drugs used for...

FDA Investigates Safety of CAR T-Cell Therapy

by Veronica Salib

In a safety notice published on November 28, 2022, the United States Food and Drug Administration (FDA) announced an investigation into the safety of chimeric antigen receptor (CAR) T-cell...

Quest, Universal DX Collaborate to Advance Colorectal Cancer Screening

by Veronica Salib

On November 20, 2023, Universal DX (UDX), a biotechnology company, announced its collaboration with Quest Diagnostics, one of the two most significant lab services in the United States, to study,...

FDA Authorizes First Chlamydia, Gonorrhea At-Home Sample Test

by Veronica Salib

On Wednesday, the United States Food and Drug Administration (FDA) authorized the Simple 2 Test manufactured by LetsGetChecked. The test is the first authorized chlamydia and gonorrhea diagnostic tool...

Johnson and Johnson Reveals General Surgery Robot Timeline

by Veronica Salib

Yesterday, Johnson and Johnson MedTech issued a press release to its investors and the public detailing the timeline for its general surgery robot. According to the announcement, the company intends to...

FDA Launches Advisory Committee for Digital Health Technologies

by Veronica Salib

In a press release on October 11, 2023, the United States Food and Drug Administration announced that it created a new Digital Health Advisory Committee. According to the release, the committee will...

FDA Issues Update on the Philips BiPAP and CPAP Recalls

by Veronica Salib

Last week, the United States Food and Drug Administration released a statement updating consumers and industry leaders on the Philips Respironics recalls due to the potential risks associated with...

FDA Issues Three New Draft Guidance Documents for Medical Devices

by Veronica Salib

Last week, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued three new draft guidances to alter the 510(k) program. According to a statement...

Fifth Circuit Appeals Court Restricts Access to Abortion Pill

by Veronica Salib

On Wednesday, August 16, 2023, the United States Court of Appeals for the Fifth Circuit issued a decision that will restrict access to medication abortions. While the new ruling does not reverse the...

Gene Therapy Restores Sight in a Pediatric Patient with DEB

by Veronica Salib

Alfonso Sabater, MD, PhD, played a significant role in restoring the vision of 14-year-old Antonio Vento, a dystrophic epidermolysis bullosa (DEB) patient. Alongside two surgical procedures, a recently...

FDA Recalls Several J&J Medical Devices After Reports of Burn Injuries

by Hayden Schmidt

Tuesday, the FDA issued a Class I recall of reusable patient return electrodes produced by Johnson and Johnson subsidiary Megadyne Medical Products after receiving reports of patients suffering burn...

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...

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