The US Food and Drug Administration has granted Emergency Use Authorization to Healgen Scientific for a point-of-care combination antigen test for COVID-19 and influenza A/B.

Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo™ and Libre Rio™, which are based on Abbott's world-leading FreeStyle Libre® continuous glucose monitoring technology1, now used by about 6 million people globally2. The newly cleared systems have been intentionally designed to meet different needs – Lingo for consumers who want to better understand and improve their health and wellness, and Libre Rio for adults with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR) assay on the cobas® liat system. Producing results in just 20 minutes on a compact analyser suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV).

Diasorin today announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s new LIAISON PLEX® Yeast Blood Culture (BCY) Assay, the second molecular multiplexing panel on the LIAISON PLEX® system.

Watmind USA has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its SpeedySwab Covid + FLU A&B Self-Test.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue.

The UK Medicines & Healthcare Products Regulatory Agency on Tuesday published a proposed framework for the recognition of in vitro diagnostics that have already been cleared in other jurisdictions.

Karius®, Inc., a leader in genomic diagnostics for infectious diseases, announced today that the Karius Test® has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia.

Diasorin (FTSE MIB: DIA) announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s NxTAG® Respiratory Pathogen Panel (RPP) v2. This updated panel, an addition to Diasorin’s expanding molecular multiplexing portfolio, responds to customer needs by enhancing test usability.

Instead of a traditional speculum-involved pelvic exam to screen for cervical cancer, the US Food and Drug Administration has given the go-ahead for patients to have the option to collect their own vaginal samples for screening in a health care setting, such as at their doctor’s office, an urgent care or even a mobile clinic.