17 Spine Surgery Firsts in Q1
During the first quarter, leading spine surgeons performed a series of first‑in‑human procedures, showcasing new devices and techniques ranging from a standalone ALIF system to augmented‑reality‑guided resections. Notable milestones included Curiteva’s Inspire ALIF, Dymicron’s Triadyme‑C cervical disc, icotec’s CMORE CT system, and NGMedical’s Move‑P motion‑preserving lumbar platform. These cases represent early clinical validation for technologies that could reshape spinal surgery standards. The full list of 17 firsts is documented by Becker’s Spine Review.
Mindray North America Enters Ventilator Market
Mindray North America announced the launch of its SV900 and SV700 ventilators, marking the company’s entry into the U.S. respiratory‑care market. As the world’s second‑largest acute‑care ventilator supplier, Mindray is expanding its critical‑care portfolio with devices that combine invasive, non‑invasive...
Perfuze Receives FDA 510(k) Clearance for Millipede88 Aspiration Catheter
Perfuze obtained FDA 510(k) clearance for its Millipede88 Aspiration Catheter after the MARRS clinical study met all primary objectives. The device is the first super‑bore 0.088 catheter cleared for standalone direct aspiration, featuring a patented corrugated design that preserves lumen...
Prodeon Medical FDA 510(k) Approved for the Urocross Expander System, a Non-Permanent Retrievable Implant for Treating Benign Prostatic Hyperplasia
Prodeon Medical received FDA 510(k) clearance for its Urocross Expander System, a non‑permanent, retrievable implant designed to treat lower urinary tract symptoms caused by benign prostatic hyperplasia. Clinical data from the Expander‑2 randomized trial showed a 48.1% mean improvement in...
FDA Town Hall: FDA’s Quality Management System Regulation (QMSR) – Medical Device Risk-Based Inspections
The FDA announced a town hall to discuss its updated Quality Management System Regulation (QMSR) that will govern medical device inspections beginning February 2, 2026. The new inspection framework replaces the long‑standing Quality System Inspection Technique (QSIT) and supersedes older...
FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss
The U.S. Food and Drug Administration issued final guidance titled “Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.” The document outlines recommended non‑clinical testing and clinical study designs for devices aimed at weight loss, obesity treatment, or...
The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices
The 510(k) premarket notification pathway continues to dominate U.S. medical device approvals, but recent data show escalating safety failures and a persistent “predicate creep” problem. In Q1 2026 the FDA introduced electronic eSTAR submissions and issued draft guidance on predicate selection,...
Catalyst OrthoScience Gets FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty
Catalyst OrthoScience announced FDA 510(k) clearance for its Archer® Patient‑Specific Instrumentation (PSI), a suite of humeral and glenoid guides designed to translate 3D pre‑operative plans into the operating room. The system pairs with Archer® 3D Planning Software, supporting both anatomic...
Decision Criteria for Technology Commercialization of Medical Devices in 2026
The article updates the classic six‑factor framework for medical‑device commercialization, highlighting that Technological Feasibility, Market Size, and Reimbursement Potential remain top‑ranked but now demand AI integration, digital‑health ecosystem compatibility, and early payer engagement. Regulatory pathways have shifted dramatically with the...
Continuous Cardiac Monitoring: Redefining the “End” Of a Clinical Study?
Continuous cardiac monitoring via wearable ECG devices is reshaping clinical trials and post‑market care. Recent studies show that 14‑day monitoring after cardiac surgery uncovered atrial fibrillation in 24% of patients, many of which were missed until three‑month follow‑ups. In epilepsy...
Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care
Fresenius Medical Care has adopted PTC’s digital‑thread platform to create an intelligent product lifecycle that unifies design, quality and manufacturing data. The solution builds a shared product data foundation, enhancing traceability of requirements, design changes, and compliance documentation across cross‑functional...