MedTech News

.................... by Andrew Celentano

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.

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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.

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