17 spine surgery firsts in Q1
Several surgeons debuted spine devices and other techniques during the first quarter from cervical discs to personalized implants.
Mindray North America Enters Ventilator Market
Mindray says its entry into the ventilator market marks a significant step in expanding advanced respiratory care options for clinicians and patients, reinforcing the medical device leader’s commitment to driving innovation in healthcare.
LivaNova Receives FDA Premarket Approval for to treat Moderate to Severe Obstructive Sleep Apnea
Hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language. The next-generation, MRI-compatible device is expected to launch in the first half of 2027, pending FDA supplement review.
Perfuze Receives FDA 510(k) Clearance for Millipede88 Aspiration Catheter
Perfuze states the Millipede88 is the first 088 aspiration catheter with patented corrugated technology cleared for standalone direct aspiration — no large-bore intermediary required — backed by independently adjudicated MARRS study data showing a 77% first-pass effect1 in M1 occlusions and 96% delivery success.
EPA proposes new rule on Ethylene Oxide Emissions: Could Loosen Limits on Medical Device Sterilization
The medical device industry and EPA have been in ongoing debate over balancing the need for sterile medical equipment with concerns about pollution near sterilization plants.
Prodeon Medical FDA 510(k) approved for the Urocross Expander System, a Non-Permanent Retrievable Implant for Treating Benign Prostatic Hyperplasia
The Urocross Expander System is designed to remodel the obstructing prostatic lobes during the six-month indwell time and is intentionally retrieved, leaving no permanent foreign material behind.
JenaValve Gets FDA Nod for Trilogy Transcatheter Heart Valve (THV) to Treat Aortic Regurgitation (ssAR)
With its FDA approval, JenaValve intends to commence launch activity for the Trilogy System immediately with participating clinical study sites.
FDA Town Hall: FDA’s Quality Management System Regulation (QMSR) – Medical Device Risk-Based Inspections
On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850).
FDA Launches New Adverse Event Look-Up Tool
The FDA launched The Adverse Event Monitoring System (AEMS), calling it a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.
FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss
FDA final guidance titled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.