The Final Rule was mooted for implementation over a staged transition period, determined by a service’s risk level, by 2028.

URA has entered the consumer diabetes space, offering a new glucose feature for its ring that uses insights from Dexcom’s CGM ...

Tariffs, though designed as economic tools, have ripple effects that extend deeply into the regulatory framework of the ...

InBrain Neuroelectronics has won a €4m ($4.5m) grant from the Spanish Ministry of Industry and Tourism to develop its BCI ...

Natera has announced findings from a study evaluating its Signatera in individuals with soft tissue and bone sarcomas.

Firefly Neuroscience has completed the acquisition of Evoke Neuroscience, a developer of technologies aimed at assessing ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to GE HealthCare's Aurora nuclear medicine system and ...

Endogenex has shared results from its REGENT-1 clinical study during the Digestive Disease Week (DDW) 2025 event held in San ...

Inquis Medical has reported that the trial of its Aventus thrombectomy system for pulmonary embolism (PE) met its primary ...

Core has completed the acquisition of neurotechnology solution provider NeuroMetrix, including its Quell platform.

The FDA designation is a step forward for Neuralink as owner Elon Musk faces increasing scrutiny. The US Food and Drug ...