Diagnostic Agents

The test aids in the diagnosis of symptomatic or asymptomatic infections with C. trachomatis, N. gonorrhoeae, and T. vaginalis.

Risk-based testing recommendations expanded to include people who are or were incarcerated, those with history of sexually transmitted infections

Limits on acetaminophen levels in combination opioid products linked to declines in liver injuries; Investigational Alzheimer disease drug fails to show efficacy; Bempedoic acid assessed for reducing major adverse cardiovascular events; Commercial blood test for suspected TBIs; Mammography regulations updated.

The updates require facilities to notify patients regarding the density of their breasts, and strengthen the FDA’s oversight of facilities.

Alinity i TBI lab test measures complementary biomarkers in blood plasma and serum that are tightly correlated to brain injury when elevated.

Plasma D-dimer had comparable accuracy to CRP, ESR, fibrinogen for diagnosing periprosthetic joint infection in patients with revision hip or knee arthroplasty

The Lucira COVID-19 & Flu Home test is a single-use, nucleic acid amplification test intended for individuals with signs and symptoms consistent with a respiratory tract infection.

Gadopiclenol only requires half of the gadolinium dose of conventional nonspecific GBCAs.

Improvement observed in detection of actionable lung nodules with no increase in false-referral rates

Despite NCCN guidelines recommending FDG PET/CT, 43.6 percent of patients were imaged with CT alone before subsequent radiation therapy

Follow-up colonoscopy rates were 43.3% within 90 days, 56.1% within 360 days of positive stool-based screening test result

Prevalence of advanced neoplasms 40 to 50% lower among those who underwent repeated screening ≥10 years after a negative colonoscopy

The semi-quantitative test uses a whole blood sample to assess cellular host response by analyzing the biophysical properties of white blood cells.

BresoDX1 is designed to record a patient’s physiological signals during sleep using a sensor and a pulse oximeter.

The FDA has granted 510(k) clearance to the Hyperfine system (Hyperfine Research), a bedside magnetic resonance imaging (MRI) system.