Noah Labs Vox,™ a voice-based algorithm that detects worsening heart failure weeks before hospitalization, has received US Food and Drug Administration (FDA) Breakthrough Device Designation (BDD).
Data has become overwhelming in healthcare. While it has provided tremendous solutions and outcomes, however, it can sometimes be a problem, too! How can data utilization in Clinical Studies and a ground up data strategy help make your technologies, your team, and your trials more efficient?
Several surgeons debuted spine devices and other techniques during the first quarter from cervical discs to personalized implants.
Hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language. The next-generation, MRI-compatible device is expected to launch in the first half of 2027, pending FDA supplement review.
Perfuze states the Millipede88 is the first 088 aspiration catheter with patented corrugated technology cleared for standalone direct aspiration — no large-bore intermediary required — backed by independently adjudicated MARRS study data showing a 77% first-pass effect1 in M1 occlusions and 96% delivery success.
The Urocross Expander System is designed to remodel the obstructing prostatic lobes during the six-month indwell time and is intentionally retrieved, leaving no permanent foreign material behind.
With its FDA approval, JenaValve intends to commence launch activity for the Trilogy System immediately with participating clinical study sites.
While some wearables may be tailor made for trial use, they face challenges translating to real-world patient applications outside of a stringent trial setting, and vice versa. This creates a unique challenge for med-devs looking to bring their devices out of the trial setting and into patient care.
Rene Zoelfl, Global Industry Advisor for PTC’s MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.
While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.