A trio of medical device companies won nods from the FDA’s Center for Devices & Radiological Health this week, including a surgical sealer, a wireless cardiac monitor and a spinal plating system
The clearance means the device, which is designed to be small enough to successfully maneuver during ENT procedures, can be used in thyroidectomies, parotidectomies and open ENT procedures. More than 160,000 such operations are performed annually in the U.S., according to a press release.
Minneapolis-based Preventice won a 510(k) nod for the BodyGuardian Remote Monitoring System it co-developed with the Mayo Clinic, using peel-and-stick sensor technology licensed from Proteus Biomedical partner Avery Dennison, mobihealthnews reports.
The system is a small body sensor that attaches to the patient’s chest to track ECG, heart rate, respiration and activity level, according to the website. BodyGuardian continuously records, stores, and periodically transmits the data for up to 30 days at a time and "detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional," according to an FDA filing.
And Precision Spine said its Spine USA subsidiary won 510(k) clearance for its Slimplicity solo anterior cervical plate system.