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Results For "FDA-clearance"

54 News Found

LEX Diagnostics gets FDA nod and CLIA waiver for ultra-fast VELO system
News | February 18, 2026

LEX Diagnostics gets FDA nod and CLIA waiver for ultra-fast VELO system

The VELO system supports multiplex testing for Influenza A, Influenza B, and COVID-19, producing PCR results in six to ten minutes


Hologic’s Aptima HPV test bags FDA nod for primary cervical cancer screening
News | February 07, 2026

Hologic’s Aptima HPV test bags FDA nod for primary cervical cancer screening

Hologic has been at the forefront of cervical cancer screening for decades


FibroBiologics moves experimental psoriasis therapy into FDA review
News | January 04, 2026

FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline


Abbott’s Volt PFA System gets FDA nod
News | December 24, 2025

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life


Abbott wins FDA & CE nod for groundbreaking premature infant heart device
Medical Device | December 22, 2025

Abbott wins FDA & CE nod for groundbreaking premature infant heart device

The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds


Roche unveils major upgrade to cobas 6800/8800 systems, boosting lab efficiency
Digitisation | December 19, 2025

Roche unveils major upgrade to cobas 6800/8800 systems, boosting lab efficiency

The update promises to revolutionize laboratory workflows by optimizing resources


Minghui Pharmaceutical gets FDA green light for Phase III trials of its therapy in thyroid eye disease
Clinical Trials | December 17, 2025

Minghui Pharmaceutical gets FDA green light for Phase III trials of its therapy in thyroid eye disease

The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies


Neurizon’s ALS drug regimen cleared for launch in Healey platform trial
Clinical Trials | December 12, 2025

Neurizon’s ALS drug regimen cleared for launch in Healey platform trial

The Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled


Bengaluru healthtech firm Biomoneta secures USFDA nod for air purifier
Healthcare | December 08, 2025

Bengaluru healthtech firm Biomoneta secures USFDA nod for air purifier

Captured microbes are then neutralized on engineered microbicidal surfaces


Roche launches first rapid point-of-care test for whooping cough
News | December 04, 2025

Roche launches first rapid point-of-care test for whooping cough

The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms