I consider that the ASX market assigns to much risk to to a...

I consider that the ASX market assigns to much risk to to a company seeking a class 1 or class 2 medical device filing for FDA Clearance. I just wonder if it is well understood. There is still a level of risk, certainly, but nothing like when attempting to achieve FDA Approval for a "first of it's kind" product. For FDA clearance, the onus falls on the manufacturer to demonstrate that their product is "substantially equivalent to another (similar) legally marketed device". We are seeking FDA Clearance on the Conneqt Pulse. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.

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The FDA categorizes medical devices into Class III, Class II and Class I. Complex medical devices that are implanted in your body, life-sustaining, or have the potential to cause significant injury or illness in the body are in Class III. Those include implanted pacemakers, replacement heart valves and even breast implants.

Lower-risk devices and products used outside of the body, like condoms, motorized wheelchairs and catheters, fall into Class II and Class I. For reference, Apple's ECG app for the Apple Watch is in Class II.

What does 'FDA cleared' mean?

Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.

For instance, let's say hypothetically Apple wanted to create a blood pressure monitor, using the same design and features of one that already exists. The company could get FDA clearance if it can compare its product to another that's already on the market and demonstrate that it is it just as safe and effective, and works in the same way.

Companies must submit a "premarket notification submission" or 510(k) to the FDA so that it can review the product and clear it. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.