FDA finalizes guidance on cybersecurity for medical devices
September 27, 2023
Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October.
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.
Mountain View, California-based Levita designed its MARS minimally invasive surgical platform for the high-volume abdominal surgery market. It combines magnets and machines to reduce the number of incisions, enabling complete control during laparoscopic procedures.
The Portrait Mobile device is one of GE HealthCare’s “first major introductions in monitoring in recent years,” according to the company.
Clearance of the new system settles a controversy that began last year when Owl sold a similar pulse oximetry device over the counter, but was ordered to pull it from sale and seek regulatory approval as a medical device.