HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-Based Sleep-Disordered Breathing Analysis
- FDA 510(k) Clearance (K253390) Validates AI-Based Classification of OSA, CSA, and MSA - Subtype-Specific Respiratory Event Analysis Improves Diagnostic Precision and Supports Next-Generation Digital Biomarker Development - Advanced AI Analysis...
STARMED Receives FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication
SEOUL, South Korea, July 1, 2026 /PRNewswire/ -- STARMED, a medical device company specialising in minimally invasive treatment technologies, has announced that it has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for a...
Ascletis Announces U.S. FDA IND Clearance for Phase I Study of Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for the Treatment of Obesity
Phase I trial consists of two parts. Part A is a single ascending dose (SAD) study of ASC35 once-monthly Self-Assembling Lipid Depot (SALD) formulation; Part B is a head-to-head study of multiple ascending doses (MAD) of ASC35 once-monthly SALD...
SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership
SEOUL, South Korea, May 29, 2026 /PRNewswire/ -- South Korea-based medtech innovator SKIA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its augmented reality (AR) surgical guidance system, SKIA HEAD....
Nuance Pharma Announces IND Clearance for Actair® Pivotal Clinical Trial in China
NMPA Approval Marks Key Milestone in Advancing House Dust Mite Allergy Immunotherapy to Chinese Patients SHANGHAI, May 22, 2026 /PRNewswire/ -- Nuance Pharma today announced that the National Medical Products Administration (NMPA) has cleared its...
3Shape Receives FDA 510(k) Clearance for 3Shape Dx Software
COPENHAGEN, Denmark, April 28, 2026 /PRNewswire/ -- 3Shape today announced that the U.S. Food and Drug Administration (FDA) has granted FDA clearance for its Dx Software following a review completed on April 10. 2026. The 510(k) Premarket...
DCwire® Micro Guidewire Receives FDA 510(k) Clearance, Marking a Key Milestone in Peijia Medical's Global Expansion
SUZHOU, China, March 18, 2026 /PRNewswire/ -- Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its DCwire® Micro Guidewire has...
XellSmart Receives Fourth Consecutive US FDA & China NMPA IND Clearance for MSA-P iPSC-derived Cell Therapy
SUZHOU, China, March 2, 2026 /PRNewswire/ -- In February 2026, XellSmart Pharmaceutical Co., Ltd. (XellSmart) announced that it had secured its fourth US FDA and China NMPA clearance for Phase I/II registrational clinical trial entry with its...
FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities
MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with WASPLab® full laboratory automation, received FDA 510(k) clearance as a Class II device in the United...
CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial
CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial in patients with advanced solid tumors. This marks a...