MedTech Intelligence

The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. This dynamic which scrutinized ...
Taiwan News

Elutia Reports Fourth Quarter and Full Year 2025 Financial Results; Initiates NXT-41 Regulatory Process

Base biologic matrix NXT-41 submitted to FDA; on track for anticipated FDA clearance in second half of 2026 and full NXT-41x clearance in 1H27 – – $44.4 million in cash an ...
Le Lézard

Cairn Surgical Announces FDA De Novo 510(k) Submission for Breast Cancer Locator System

Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that it has submitted a De Novo 510(k) application to the U.S. Food and ...
Zacks Investment Research on MSN

GEHC wins FDA 510(k) approval for View, enhances radiology workflows

GE HealthCare Technologies Inc. GEHC recently announced that the FDA has granted 510(k) clearance for View, a next-generation diagnostic imaging viewer within its Genesis Radiology Workspace. For ...

Apyx Medical outlines 9%–11% revenue growth target for 2026 as AYON launch accelerates

Q4 2025 Management View Charles Goodwin, President and CEO, opened by highlighting a record revenue of $19.2 million for the quarter, driven by a 38% increase in surgical aesthetics product sales to ...

Global Point-of-Care Molecular Diagnostics Market Projected to Reach USD 13.05 Billion by 2035; Growth is Driven by Increasing Need for Fast Near-Patient Testing Globally ...

Based Platforms, Isothermal Amplification Technologies, and Lab-on-a-Chip Systems Accelerating Market Expansion Globally.Austin, United States, March 09, 2026 (GLOBE NEWSWIRE) -- Point-of-Care ...
Agence France-Presse

Mevion Medical Systems Announces CE Marking of the MEVION S250-FIT™ Proton Therapy System, Expanding Global Access to Compact Proton Therapy

The MEVION S250-FIT is the first and only proton therapy system designed to fit into a standard radiation therapy vault. By enabling cancer centers to use their existing infrastructure, the MEVION ...
Times Argus

Catalyst OrthoScience Announces FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty

Catalyst OrthoScience Inc. (“Catalyst”), a private medical technology company redefining shoulder arthroplasty through simplified, surgeon-focused innovation, today announced U.S. Food and Drug ...

Gentherm Earnings Call: Growth Push Amid Margin Strain

Foreign exchange movements diluted reported growth, trimming the top line from 2.9% to 1.8% when measured ex-FX. Gentherm also flagged local currency volatility, particularly the peso, as a specific ...
Business Insider

LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System

CAMBRIDGE, United Kingdom, Feb. 16, 2026 (GLOBE NEWSWIRE) -- LEX Diagnostics, a leading innovator in molecular diagnostics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and ...
Business Insider

Gentherm Announces FDA 510(k) Submission for Innovative Technology Expected to Promote Safer Surgeries and Better Patient Outcomes

NOVI, Mich., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Gentherm (NASDAQ: THRM) a global market leader of innovative thermal management and pneumatic comfort technologies, today announced it submitted a 510(k) ...