Sepsis

Abionic’s IVD Sepsis Detection Test Receives FDA 510(k) Clearance

Abionic's IVD CAPSULE PSP test gained FDA 510(k) clearance to rapidly detect sepsis, marking the company's expansion into the U.S. market.

Sepsis

New Sepsis Test Provides Faster and Reliable Results

Doctors from Norway received test results two days earlier than before when they tested a new way to analyze blood for suspected sepsis.

Sepsis

Inflammatix Completes Technical Development of Acute Infection and Sepsis Test System

The test system is intended to be used in emergency department settings in patients with suspected acute infection and sepsis.

Cytovale Unveils Commercial Launch of Sepsis Test for Emergency Departments

Aug 2, 2023 | Sepsis

Cytovale announced the U.S. commercial launch of the IntelliSep sepsis test following FDA 510(k) clearance in December 2022.

Why Better Sepsis Diagnosis Results in Better Outcomes

Jun 7, 2023 | Sepsis

Delay in sepsis diagnosis increases the risk of dying by 8% every hour; and can lead to the unnecessary use of strong antibiotic therapies.

C. auris Diagnostic Submitted for FDA Breakthrough Device Designation

Jun 6, 2023 | Molecular Diagnostics, Sepsis

T2 Biosystems Inc. has submitted an application with the FDA for Breakthrough Device Designation for the company’s Candida auris test.

Rapid Diagnostic Test for Sepsis Validated for Emergency Department

May 23, 2023 | Sepsis

Researchers presented data that validate a rapid diagnostic test for sepsis at the American Thoracic Society 2023 International Conference.

AACC Releases Guidance on Procalcitonin Testing

May 5, 2023 | Sepsis

AACC has issued expert guidance on clinical testing for procalcitonin, a blood marker that helps detect serious bacterial infections and sepsis.

Large-Scale Study Details Devastating Patient Harms Associated with Blood Culture Contamination

Jan 25, 2023 | Culture Media, Sepsis

Magnolia Medical Technologies shared a study detailing the clinical and financial impacts of blood culture contamination on patient safety.

FDA Clears Cytovale’s IntelliSep Sepsis Test

Jan 18, 2023 | Diagnostic Technologies, Sepsis

Cytovale, a medical diagnostics company focused on advancing early detection technologies, announced that its IntelliSep test has received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis.

Asep Medical Holdings Clarifies Update on Diagnostic Technologies

Dec 29, 2022 | Company News, Sepsis

At the request of IIROC, Asep Medical Holdings clarified its disclosure regarding its diagnostic and therapeutic technologies.

Machine Learning Enables Enhanced Diagnosis of Sepsis

Oct 25, 2022 | Sepsis

Researchers have developed a new diagnostic method that applies machine learning to advanced genomics data to identify and predict sepsis.

T2 Biosystems Expanding Panel to Detect More Blood Stream Infections

Oct 20, 2022 | Sepsis

T2 Biosystems is expanding the number of pathogens detected on its T2Bacteria Panel to include the detection of Acinetobacter baumannii.

Reviewing Limitations of Current Lab Inputs To Antibiotic Decision Making

Sep 2, 2022 | Sepsis

A simple test that can be a beacon for improved patient outcomes, shorter lengths-of-stays, and reduced rates of antibiotic prescription and antibiotic resistance1-6