Titan Medical Inc (TMDIF)

[elMoose]

It is amazing that after 30 years you can't distinguish the difference between different type of devices and the reason for specific FDA requirements . A pacemaker is an embedded device with embedded firmware. Firmware is software but it is part of the hardware. Firmware and Gui interface are two different things altogether. One controls the device and the other is the user interface.

Firmware or embedded software inside a device that is inserted in human body that controls the heart and it is a piece of hardware. Hardware is not just a chip and it includes firmware.

The Robotic arms also have internal firmware that is integrated with hardware and that is not the same thing as a GUI interface or a user interface. Hardware is not just a piece of metal or a chip but it also has integrated firmware that is specifically designed for control of the device without which the hardware will not be functional. That is what gets frozen and tested.

Firmware is in ROM, flash memory and it is rarely updated unless there are bugs.

Notice FDA is referencing firmware and not software or Gui update in a pacemaker.

example:
'FDA recalls 465,000 pacemakers for firmware update'