In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.
The ArteraAI prostate biopsy assay predicts the risk of prostate cancer progression.
Approval for Xeltis’s aXess device was based on pivotal trial data that demonstrated 79% secondary patency and a patency related reintervention rate of 1.3 per patient year.
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its Rembra platform of scanning systems.
Sonorous Neurovascular announced today that it received FDA 510(k) clearance for its BosCATH next-generation neurovascular catheter.
Luminoah announced today that it received FDA clearance for Luminoah Flow, an enteral feeding system for those who rely on tube feeding.
Broader indications reinforce SINEFIX as a versatile alternative to traditional suture anchors for soft tissue-to-bone fixation.
EXETER, N.H., April 21, 2026 /PRNewswire/ — Vapotherm, Inc., a developer and manufacturer of advanced respiratory technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its All Patient Circuit (APC™) which now includes therapy settings for neonatal and infant patients. The cleared APC enables the HVT 2.0 high velocity therapy system to deliver therapy across a 2–45 L/min flow range using a single disposable patient circuit.
LEXINGTON, Mass., April 21, 2026 (GLOBE NEWSWIRE) — Hyalex Orthopaedics today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its HYALEX Slalom™ MTP Hemiarthroplasty Implant, a next-generation implant designed around the proprietary Hydrosurf™ materials platform, for the treatment of degenerative conditions affecting the first metatarsophalangeal (MTP) joint, including hallux rigidus.
BVI Medical announced today that it received CE mark for its Virtuoso next-generation phaco-vitrectomy surgical platform.