Category: CERTIFICATIONS - Page 58 - Start Medical Product Development

Nitinotes Receives CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty

November 6, 2025

CAESAREA, Israel, Nov. 6, 2025 /PRNewswire/ — Nitinotes Ltd., a medical device company transforming the treatment of obesity, today announced it has received CE Mark approval for the EndoZip™ System, the first fully automated suturing platform for endoscopic sleeve gastroplasty (ESG). The milestone clearance enables Nitinotes to begin commercialization across the European Union and other CE Mark-accepting markets.

W&H Medical Unveils FDA-Cleared Piezo & Drill Combo Console for Rhinoplasty and Facial Surgery

November 6, 2025

Driven by high-frequency piezo technology, the console enables precise, tissue-sparing bone cutting while protecting nerves, vessels, and soft tissues

Medical Microinstruments wins FDA IDE for robotic microsurgery for Alzheimer’s

November 5, 2025

Medical Microinstruments (MMI) announced today that it received FDA investigational device exemption (IDE) to study its microsurgery platform

BD gains FDA clearance and CE mark for bacterial panels on COR System

November 4, 2025

The panels employ PCR techniques to test for numerous gastrointestinal bacterial pathogens using one stool swab.

Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes

November 4, 2025

Aqua Medical has received an investigational device exemption (IDE) from the FDA for its ablation device intended to treat diabetes, the company told MassDevice ahead of an official announcement later today.

QuidelOrtho Receives FDA 510(k) Clearance for VITROS™ Immunodiagnostic Products hs Troponin I Assay

November 3, 2025

SAN DIEGO, Nov. 3, 2025 /PRNewswire/ — The U.S. Food and Drug Administration (“FDA”) has granted QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the “VITROS hs Troponin I Assay”). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).

Blog

- CERTIFICATIONS

Nitinotes Receives CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty

W&H Medical Unveils FDA-Cleared Piezo & Drill Combo Console for Rhinoplasty and Facial Surgery

Medical Microinstruments wins FDA IDE for robotic microsurgery for Alzheimer’s

BD gains FDA clearance and CE mark for bacterial panels on COR System

Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes

QuidelOrtho Receives FDA 510(k) Clearance for VITROS™ Immunodiagnostic Products hs Troponin I Assay

FDA clears InterVene’s in-stent restenosis catheter

Pulsenmore wins FDA nod for at-home prenatal ultrasound

FDA expands indications for Wandercraft robotic exoskeleton

FDA grants 510(k) clearance to Sirona Medical’s imaging suite