A menstrual pad designed with a removable strip to collect blood samples for clinical tests has been granted clearance by the US Food and Drug Administration (FDA).

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

The US Food and Drug Administration (FDA) has granted breakthrough device designation to CanScan, the multi-cancer early detection solution by Canadian medtech Geneseeq.

Molecular diagnostic firm T2 Biosystems announced Wednesday that it has submitted a 510(k) premarket notification to the US Food and Drug Administration to expand the use of its T2Candida Panel for pediatric testing.

The US Food and Drug Administration announced on Tuesday that it has approved AutoGenomics' test to determine whether a patient has an elevated risk of developing opioid use disorder (OUD).

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received 510(K) clearance from the U.S. Food and Drug Administration for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2) and Varicella-zoster virus (VZV) nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens obtained from symptomatic patients.

Significant regulatory changes across numerous medical fields are coming in 2024 with pharmaceutical and medical device companies urged to be ready for a year of legal alterations.

Canadian diagnostics firm MedMira on Wednesday said it has secured US Food and Drug Administration 510(k) clearance for the HIV-2 claim that will be used in its rapid antigen tests for HIV-1/2 detection.

Abbott’s new laboratory automation system has received U.S. Food and Drug Administration (FDA) approval, the company announced in a statement.