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Posted On: 06/19/2022 3:09:40 PM
Post# of 72440
Squalus, IPIX's partner, is planning to have the new system evaluated by the FDA 510k path.
IMO the system is likely to use a laser already approved for human treatment, since the PR did not mention a new laser.
In addition laser treatments have been performed for a number of years for all the indications indicated in the PR, epilepsy and tumors of the brain, lung,prostate,breast and liver.
The Squalus laser system may be viewed by the FDA primarily as an imaging and software change to better direct the laser treatment and as such may require a much shorter path to the 510k approval.
Investors will have to wait until these points are clarified by the FDA and Squalus.
https://www.fda.gov/media/99785/download
The quote below does not apply to the Squalus system since it is applying for the 510k designation. It is placed here to show software changes are held to a different level of scrutiny.
"Many software functions are not medical devices (meaning such software functions do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them as devices."
https://www.fda.gov/media/80958/download
Good luck, Farrell
IMO the system is likely to use a laser already approved for human treatment, since the PR did not mention a new laser.
In addition laser treatments have been performed for a number of years for all the indications indicated in the PR, epilepsy and tumors of the brain, lung,prostate,breast and liver.
The Squalus laser system may be viewed by the FDA primarily as an imaging and software change to better direct the laser treatment and as such may require a much shorter path to the 510k approval.
Investors will have to wait until these points are clarified by the FDA and Squalus.
https://www.fda.gov/media/99785/download
The quote below does not apply to the Squalus system since it is applying for the 510k designation. It is placed here to show software changes are held to a different level of scrutiny.
"Many software functions are not medical devices (meaning such software functions do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them as devices."
https://www.fda.gov/media/80958/download
Good luck, Farrell
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