Latest medtech regulatory news

Single-use digital flexible ureteroscope system

The LithoVue Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope system with the ability to monitor intrarenal pressure in real-time during ureteroscopy procedures, received U.S. Food and Drug Administration (FDA) 510(k) clearance.

The LithoVue Elite System consists of the single-use digital flexible ureteroscope and the StoneSmart Connect Console, building on the features of the original LithoVue System but with significant next-generation innovations. In addition to intrarenal pressure monitoring, device enhancements include:

Upgraded image quality: High-resolution digital chip and advanced imaging software provides faster, sharper image quality and greater depth of field

Updated control features: Two programmable buttons on the lightweight, single-use ureteroscope handle enable direct control of video, image capture

Streamlined integration: StoneSmart Connect Console, LithoVue Elite’s compact processing unit, works with existing operating room visualization towers, endoscopic monitors to reduce clutter, capital footprint

Boston Scientific:
https://www.bostonscientific.com/LithoVueElite

FDA-cleared Pyrocarbon bearing material option for shoulder hemiarthroplasty

Armodios M. Hatzidakis, MD, FAAOS, Western Orthopaedics, PC, Denver Surgery Center and Rose Medical Center, has successfully completed the first case in the United States since the De Novo clearance using the Tornier Pyrocarbon Humeral Head. Stryker’s De Novo request was granted in late 2022 after completing an Investigational Device Exemption (IDE) study with the U.S. Food and Drug Administration (FDA).

Pyrocarbon is an advanced bearing material with surface properties more similar to bone than traditional orthopedic metallic bearing surfaces. It has been used internationally for a variety of orthopedic procedures since the early 1990s and in shoulder cases since 2013. Stryker is the first company to offer an FDA-cleared pyrocarbon implant for shoulder hemiarthroplasty in the U.S.

Stryker: https://www.stryker.com