Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 14

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 14
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 production; refusal to
grant future clearances, approvals or certifications; withdrawals or suspensions of clearances, approvals or certifications, resulting
in prohibitions on sales of our products; and in the most serious cases, criminal penalties.

We may not receive, or may be delayed in
receiving, the necessary marketing authorizations or certifications for our Alpha DaRT technology or any future products or product candidates,
and failure to timely obtain necessary marketing authorizations or certifications for our product candidates would have a material adverse
effect on our business.

In the United States, before
we can market a new medical device, or a new use of, or other significant modification to an existing, marketed medical device, we must
first receive either clearance under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, or the FDCA, approval of a premarket
approval application, or PMA, or grant of a de novoclassification request from the FDA, unless an exemption applies. In the 510(k)
clearance process, before a device may be marketed, the FDA must determine that a proposed device is “substantially equivalent”
to a legally-marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process,
a device that was legally marketed prior to May 28, 1976 (pre-amendments device), a device that was originally on the U. S. market pursuant
to an approved PMA and later down-classified, or a 510(k)-exempt device. To be “substantially equivalent,” the proposed device
must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device
or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device.
Clinical data are sometimes required to support substantial equivalence. In the process of obtaining PMA approval, the FDA must determine
that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical,
pre-clinical, clinical trial, manufacturing and labeling data. The PMA process is typically required for devices that are deemed to pose
the greatest risk, such as life-sustaining, life-supporting or implantable devices. In the de novoclassification process, a manufacturer
whose novel device under the FDCA would otherwise be automatically classified as Class III and require the submission and approval of
a PMA prior