Category: CERTIFICATIONS - Page 2 - Start Medical Product Development

Maverix Medical Expands the Narwhal™ Cryo Portfolio with FDA Clearance of the Narwhal Pro

October 14, 2026

MENLO PARK, Calif., Oct. 14, 2026/PRNewswire/ — Maverix Medical, a company focused on revolutionizing the diagnosis and treatment of lung cancer, has augmented its console-free cryoprobe portfolio. Today the company announced that the U.S. Food and Drug Administration granted 510(k) clearance on September 2, 2026, to the Maverix Narwhal™ Pro Cryo System, the second of two flexible cryoprobes built on the same cartridge-powered architecture.

Florida Cancer Specialists & Research Institute Contributes to Two Significant FDA Approvals Advancing Breast and Pancreatic Cancer Care

October 14, 2026

FORT MYERS, Fla., Oct. 14, 2026 /PRNewswire/ — Florida Cancer Specialists & Research Institute, LLC (FCS) is celebrating its pivotal role in the development of two recently approved targeted therapies that expand treatment options for patients with advanced breast and pancreatic cancers, underscoring the FCS’s longstanding commitment to advancing oncology research and expanding access to clinical trials.

FDA grants 510(k) clearance for Urolution Medical’s OpenFlo catheter

October 12, 2026

Urolution Medical is preparing comparative clinical trials to evaluate catheter performance and patient outcomes.

E2 Secures Dual FDA Clearances for the Hēlo® Platform, Introducing a PE Thrombectomy System with Integrated Blood Return

October 12, 2026

Combination of Hēlo Thrombectomy System and Hēlo Return establish the first 510(k)-cleared platform compatible with continuous vacuum aspiration

RingConn Receives FDA 510(k) Clearance for Non-Invasive Blood Oxygen (SpO2) Measurement

October 10, 2026

Shenzhen, China, Oct. 10, 2026 /PRNewswire/ — Shenzhen Ninenovo Technology Limited, the parent company of RingConn, announced that its Smart Ring has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for non-invasive blood oxygen (SpO2) measurement (Clearance No. K260490).

Okami Medical Receives FDA Expanded Indication for LOBO Vascular Occluder in Peripheral Veins

October 8, 2026

Okami Medical has announced that the U.S. Food and Drug Administration (FDA) has granted an expanded indication for its LOBO Vascular Occlusion System.

Sonorous wins FDA IDE for pulsatile tinnitus stent pivotal trial initiation

October 8, 2026

Sonorous’ FDA IDE approval follows its BosSTENT’s receipt of FDA breakthrough device designation in February 2026.

FDA grants de novo nod to handheld ER cardiac implant identifier

October 8, 2026

BridgeSource Medical obtained de novo clearance from the FDA for its handheld cardiac implant identifier, designed to help emergency department clinicians quickly identify a patient’s hardware brand.

ClaroNav Kolahi Receives EU MDR Certification for Navient Surgical Navigation System

October 7, 2026

ClaroNav Kolahi has received certification under the European Union Medical Device Regulation (MDR) for its Navient Surgical Navigation System, covering the Navient Image Guided Navigation System and its reusable surgical instruments, allowing the company to continue offering Navient throughout the European Union under the EU MDR regulatory framework.

icotec Receives CMS approval for New Technology Add-On Payment for its CMORE® CT System

October 6, 2026

ALTSTÄTTEN, Switzerland and BOSTON, Oct. 6, 2026 /PRNewswire/ — icotec, the global leader in radiolucent implants for spine tumors and other complex spinal surgery patients, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved a New Technology Add-On Payment (NTAP) for icotec’s spine implant system, CMORE® CT, effective October 1, 2026.

Blog

- CERTIFICATIONS

Maverix Medical Expands the Narwhal™ Cryo Portfolio with FDA Clearance of the Narwhal Pro

Florida Cancer Specialists & Research Institute Contributes to Two Significant FDA Approvals Advancing Breast and Pancreatic Cancer Care

FDA grants 510(k) clearance for Urolution Medical’s OpenFlo catheter

E2 Secures Dual FDA Clearances for the Hēlo® Platform, Introducing a PE Thrombectomy System with Integrated Blood Return

RingConn Receives FDA 510(k) Clearance for Non-Invasive Blood Oxygen (SpO2) Measurement

Okami Medical Receives FDA Expanded Indication for LOBO Vascular Occluder in Peripheral Veins

Sonorous wins FDA IDE for pulsatile tinnitus stent pivotal trial initiation

FDA grants de novo nod to handheld ER cardiac implant identifier

ClaroNav Kolahi Receives EU MDR Certification for Navient Surgical Navigation System

icotec Receives CMS approval for New Technology Add-On Payment for its CMORE® CT System