
Press Release: Boston Scientific receives CE Mark for the new 25 mm Lotus valve system

The Medical Device Business Journal — Medical Device News & Articles | MassDevice
LYON, France — EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the U.S. Food and Drug Administration (FDA) concluded its routine inspection of EDAP’s manufacturing site with no findings nor issuance of Form 483 observations.
MALVERN, Pa. — Siemens Healthcare has announced that it recently submitted to the U.S. Food and Drug Administration (FDA) its premarket approval application (PMA) for the MAMMOMAT Inspiration® with Breast Tomosynthesis option.
GOLETA, Calif. — Inogen, Inc. (Nasdaq:INGN) announced today that it has received FDA clearance for an innovative home oxygen concentrator called the Inogen At Home.