FDA clears Owlet over-the-counter pulse oximeter sock for infants
November 9, 2023
Lehi, Utah-based Owlet designed the system to enable caregivers to better care for babies at home through advanced digital technologies.
Lehi, Utah-based Owlet designed the system to enable caregivers to better care for babies at home through advanced digital technologies.
Recor Medical announced that the FDA approved its Paradise ultrasound renal denervation (RDN) system for treating hypertension.
Interventional Systems announced that the FDA granted a new 510(k) clearance for its Micromate surgical robot system.
DePuy Synthes, the orthopedic device business of Johnson & Johnson (NYSE: JNJ)+
, has won FDA 510(k) clearance for its TriLeap lower extremity anatomic plating system.
Medtronic (NYSE:MDT) announced that the FDA approved its next-generation SynchroMed III intrathecal drug delivery system
ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that its LIFT implant technology has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
The money also will help fund clinical trials for additional indications and the expansion of its manufacturing capabilities.
The startup affiliated with Johns Hopkins University said it is opening a bridge round for its series B financing as it targets more applications for the robotic surgery assistant.
Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October.
South Korea–based Wellysis announced today that it has secured FDA clearance for its S-Patch Ex. The device already has a CE Mark, with Wellysis marketing the S-Patch Ex in 14 countries.