Current regulatory news

US FDA 510(k) CLEARANCES

Pleural Dynamics’ ACES Automatic Continuous Effusion Shunt System is an automatic effusion shunt. This one-piece, fully implanted system can be placed during a short hospital stay. The technology uses normal breathing motion to automatically pump pleural effusion fluid out of the chest to the abdomen for reabsorption by the body, eliminating the need for an external catheter and frequent drainage, providing ongoing symptom relief. https://www.pleuraldynamics.com

Stryker’s Pangea Systems – including Femur, Fibula, Tibia, Humerus, and Utility – offer an evidence-based design for implant fit. The system enhances plate fit and screw placement while elevating the plating market through anatomically contoured implants in patient populations with a wide variety of fracture patterns. The intuitive and streamlined instrumentation and implant trays will include 20 anatomic plates and 13 utility plates accessible in one platform.

https://www.stryker.com

Exactech Activit-E polyethylene for the Vantage Total Ankle System is a next-generation highly crosslinked polyethylene with vitamin E antioxidant stabilization. The system’s unique manufacturing process replaces gamma irradiation crosslinking with peroxide crosslinking and adds vitamin E to provide strength, flexibility, toughness, and oxidative stability. This technology also ensures patients can access the clinical benefits of highly crosslinked polyethylene despite the anticipated shortage of gamma radiation for crosslinking.

http://www.exac.com

InfoBionic’s MoMe ARC is the company’s 3rd-generation remote electrocardiogram (ECG) monitoring device paired with its Bluetooth diagnostic 6-lead sensor to aid physicians in diagnosing cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe ARC includes a 4-in-1 gateway device that transitions between 2-day and Extended Holter tests, Event, and mobile cardiac telemetry (MCT) modes remotely, streamlining patient monitoring time and minimizing delays. In addition, MoMe ARC leverages a cloud-based platform to deliver on-demand, actionable data and analytics directly to the clinicians.