The expanded 510 (k) clearance is publicly available in the FDA's 510 (k) Premarket Notification database under device number K253939.

Company Transitions from Infrastructure Buildout to Active Market Execution as Expanded 510(k) Review Enters Final ...

Microsoft MSFT and Oracle ORCL have emerged as two dominant players capitalizing on the enterprise cloud and artificial intelligence revolution. Both companies are investing billions in AI ...

1519 GMT – The Japanese yen might sustain a recovery if it breaks sustainably beyond key chart support at 154.50 yen per dollar, Societe Generale’s Kit Juckes says in a note. The Japanese currency has ...

Certain Philips Respironics DreamStation breathing devices, commonly used for treating sleep apnea, may deliver the incorrect prescription or no therapy at all, the FDA warned in a recall announcement ...