Telix has completed enrollment of 350 patients in the Phase 3 BiPASS study testing Illuccix and Gozellix PSMA-PET with MRI before prostate biopsy and has aligned with the FDA on an NDA pathway.
A peer-reviewed CIZ1B-FibA study reported 94% sensitivity and 97% negative predictive value in one early-stage lung cancer cohort, while identifying pre-analytic variability that must be resolved before broader clinical validation.
Beyond Air’s LungFit GO has received FDA Breakthrough Device designation for nontuberculous mycobacterial pulmonary disease after a 15-patient pilot showed high-dose nitric oxide could be self-administered at home.
Abbott’s investigational TactiFlex Duo dual-energy ablation catheter delivered favorable 12-month results in the FlexPulse Global IDE study, supporting the company’s effort to secure U.S. FDA approval after receiving CE Mark in Europe.
Health Canada has issued Class II medical-device licenses for Fujirebio’s Lumipulse G pTau217 Plasma and NfL Blood assays, expanding automated blood-based neurological testing for Alzheimer’s pathology and neuro-axonal injury.
Final MARRS pivotal-trial results show Perfuze’s FDA-cleared Millipede88 aspiration catheter achieved 89% successful reperfusion without rescue therapy and a 75% first-pass effect in M1 middle cerebral artery occlusions.
The EFICAS study of the Aeson Total Artificial Heart achieved its primary endpoint in 72.7% of 55 severely ill patients, with 96% remaining free of disabling stroke at 180 days and 76% discharged from hospital.
The FDA is warning patients who received mammograms at Mammography Center of Monterey on or after December 22, 2023 about possible image-quality problems after the facility failed an additional review and some deficiencies were classified as severe.
GE HealthCare’s Photonova Spectra has secured CE Mark after earlier U.S. FDA clearance and Japanese approval, accelerating the global expansion of photon-counting CT technology that promises higher-resolution and spectral imaging from individual X-ray photons.
FDA records show a De Novo grant for Brixton Biosciences’ ReneuRx, also known as Neural Ice, a nerve-selective technology developed as a drug-free injectable approach to longer-lasting knee osteoarthritis pain control.