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).
FDA clearance of the BCL System will give surgeons access to precise information about each breast tumor that has never before been available to them, according to the company.
Several surgeons debuted spine devices and other techniques during the first quarter from cervical discs to personalized implants.
Mindray says its entry into the ventilator market marks a significant step in expanding advanced respiratory care options for clinicians and patients, reinforcing the medical device leader’s commitment to driving innovation in healthcare.
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.
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.
A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S. Food and Drug Administration’s (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.
Originally CE marked in 2021 for limited to high-risk patients only, .Abbott has now received CE mark approval for its Navitor transcatheter aortic valve replacement (TAVR) system to treat low- and intermediate-risk patients with symptomatic, severe aortic stenosis.
The company initiated trials for AGENT DCB, a drug-coated coronary balloon approved for use in the U.S. and currently indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.