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retirewell

183 Posts.

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11/01/24

09:47

Post #: 71825562
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Originally posted by strangelogic: ↑

Nice find. I work in biomedical product development and deal with classification regularly.
The classification is a way of determining how the device manufacturer approaches risk management and mitigation. It does not necessarily mean a particular setting is going to be encountered but does ensure that for devices that will provide a critical part in ensuring patient (and user) safety, there are appropriate levels of risk management to avoid harm from the device. it is often dependent on the intended use for the device(which can change) and indications for use.

For instance if the device provides information to a clinician who then can choose to use that information as well as other information to make a diagnosis then the device may not be the determining factor in whether the patient will suffer harm. Often passive devices such as thermometers, etc that provide supporting clinical information are IIa.

However if the device provides diagnostic information that will be the basis of treatment that may prevent significant harm or the device application may be harmful but the benefit is deemed worth the risk when the potential for harm is mitigated, then that would be at least class IIb,

The classification change to IIb to me indicates there is a strong diagnostic value that can now be proven and influences the indications for use. The device is no longer just providing general information to a clinician, but giving guidance on disease state in some form that will allow a diagnostic conclusion upon which to base treatment.

This is all IMO based on experience and not medical advice.

The impact is also a greater regulatory burden on the device manufacturer and higher ongoing scrutiny of risk management and product performance monitoring by regulators. This may not be significant if the company was planning to apply for a higher class effectively and have been collecting the data to do so along the way which is supported by the trials underway.

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Thankyou for this analysis it is greatly appreciated to help my education on what I believe will be a world leading company

4DX Price at posting: 71.0¢ Sentiment: Hold Disclosure: Held
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0 Great analysis

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Research, page-2232

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