MedTech News
.................... by Andrew Celentano
FDA Approves Expanded Clinical Applications for SINEFIX™ in Soft Tissue Repair
Broader indications reinforce SINEFIX as a versatile alternative to traditional suture anchors for soft tissue-to-bone fixation.
Vapotherm® Announces FDA 510(k) Clearance for the All Patient Circuit™, Enabling High Velocity Therapy for Neonatal to Adult Patients
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.
Hyalex Orthopaedics Announces FDA 510(k) Clearance of the HYALEX Slalom™ MTP Hemiarthroplasty System
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.
Implanted nerve stimulation for obstructive sleep apnea found to be safe and effective
Researchers conducted the OSPREY (treating Obstructive Sleep aPnea using taRgEted hYpoglossal nerve stimulation) trial to better understand the safety and efficacy of pHGNS.
AI screening in brain organoids uncovers two drug candidates for Leigh syndrome
Together with a team from the University of Luxembourg, researchers from Heinrich Heine University Düsseldorf (HHU) and University Hospital Düsseldorf (UKD) have succeeded in utilizing artificial intelligence (AI) to establish a model that enables a better understanding of Leigh syndrome.
Mini brain-like structures grown in lab may help scientists treat, diagnose and stage Alzheimer’s disease
Scientists from Johns Hopkins Medicine report new evidence that clusters of brain tissue derived from the cells of patients with Alzheimer’s disease may be used to evaluate how certain patients with the neurodegenerative condition may respond to drugs commonly prescribed to treat psychiatric symptoms of the disorder.
A new skin-hugging heart monitor material could make long-term ECG tracking far more comfortable
Researchers have created heart monitoring sensors that conform to the skin, are comfortable, and can be worn while people are moving.
BVI wins CE mark for Virtuoso dual-function platform
BVI Medical announced today that it received CE mark for its Virtuoso next-generation phaco-vitrectomy surgical platform.