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Results For "FDA-clearance"

62 News Found

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


a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system
News | November 30, 2025

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system

Abdomen-pelvis CT is the nation’s highest-volume CT category


Transmural Systems wins breakthrough FDA nod for coronary-saving TAVR device
Medical Device | November 27, 2025

Transmural Systems wins breakthrough FDA nod for coronary-saving TAVR device

The clearance for TELLTALE positions Transmural Systems at the forefront of next-generation electrosurgical solutions for structural heart interventions