Telemed

Telemed specialises in ultrasound imaging devices. Their product line includes portable ultrasound systems like the ECHO BLASTER, handheld ultrasound probes such as the ArtUs and MicrUs, and dedicated ultrasound scanners including the LOGICSCAN 64 and LOGICSCAN 128. They also produce extension cables for ultrasound transducers, like the SmartUs EXT-1M/3M, designed to enhance connectivity for existing ultrasound systems.

Telemed is based in the United States. Their devices are authorised for commercial distribution in the US market, where they comply with applicable regulatory requirements.

Telemed’s devices are classified as Class II under FDA regulations. This classification is determined by the level of risk associated with the device, with Class II devices requiring special controls in addition to general controls to ensure safety and effectiveness. The classification ensures that these devices undergo rigorous review processes to maintain regulatory compliance.

Telemed’s devices are listed via the FDA’s 510(k) pathway. This pathway is used for devices that are substantially equivalent to legally marketed devices already on the market. The 510(k) process involves submitting pre-market notifications to demonstrate that the new device is as safe and effective as the predicate device, ensuring compliance with FDA requirements before commercial distribution.