Trace - True Ray Tracing Aberrometer and Topographer Tracey Technologies announced that the company has successfully achieved certificatio ...

The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

Tracey Technologies’ iTrace uses ray tracing technology to obtain precise measurements of the eye’s internal and external ...

The Union ministry of chemicals and fertilisers need to sensitize the States on their arrangements for licensing and regulation of the Class A and B categories of medical devices, in order to avoid ...

For healthcare firms involved in the spaces of software-as-a-medical-device ... not Class IIa or higher, you’re almost certainly not,” added Gilbert. Similar to complying with the EU MDR ...

For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.

TBS Osteo remains the only approved medical device software for evaluating bone microarchitecture in clinical settings. Since 2022 it benefits from four Category 1 reimbursement CPT ... collaborations ...

Revenues increased 14% for the quarter compared to prior year and 13% year-to-date Positive cash flow from operations for the quarter with $5.2 million of ...

and articles used independently or in combination for healthcare applications (MDR, Article 2.1) (1). High-risk medical devices (class III and class IIb implantable; Article 51, MDR) encompass more ...