The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions
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Israel on Friday revised down the death toll from last month's Hamas attacks in southern Israel from 1,400 to about 1,200, according to a foreign ministry spokesman.
"This is an updated estimate," ministry spokesman Lior Haiat told AFP.
Israel previously said Hamas fighters who poured across the heavily militarised border on October 7 killed 1,400 people, mostly civilians.
But in an unrelated statement on Friday that was critical of the UN's cultural agency Unesco, Haiat said Hamas murdered "about 1,200 people".
Haiat separately confirmed the new toll in a statement to AFP.
Palestinians reported deadly strikes or sniper fire at two hospitals and a school.
The Israeli army, which has agreed to some pauses in shelling to allow civilians to flee northern Gaza, has accused Palestinian militant group Hamas of using hospitals as command centres and hideouts. Hamas denies the accusations.
The director of the Al Shifa hospital and the Hamas government said 13 people were killed in a strike on the institution, which they blamed on Israeli forces.
The bodies of another 50 people killed in a strike on Gaza City's Al Buraq school were taken to the hospital, the Al Shifa director said.
The Palestinian Red Crescent Society said Israeli snipers had shot at Al Quds hospital, killing at least one person.
AFP could not immediately confirm the tolls.
Israeli forces would "kill" Hamas militants if they saw them "firing from hospitals", military spokesman Richard Hecht said.
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