United States
Medical device market intelligence for United States. Regulatory changes, competitor moves, and procurement trends.
Recent signals
Philips Allura Xper Systems may experience hand switch button issues, risking imaging loss and unintended radiation exposure.
CereVasc raised $85 million to advance its eShunt system for treating normal pressure hydrocephalus.
Insulet, MiniMed, and Tandem Diabetes Care are developing fully closed-loop diabetes management systems.
Medtronic aims for 510(k) clearance for the Hugo surgical robot to compete in robotic surgery markets.
Medline received a second FDA warning letter for recurring toxic bacteria issues in its medical devices.
Medline received a second FDA warning letter for recurring toxic bacteria issues in its medical devices.
Proposed tariffs could increase hospital supply chain costs, impacting 69% of U.S. medical devices sourced overseas.
The NSS-2 BRIDGE device is explored for non-opioid post-operative pain management amid rising opioid addiction concerns.
A completed study evaluated a non-hormonal device for treating vulvovaginal atrophy in post-menopausal women.
The VIPUN GMS has completed clinical validation for gastric motility monitoring via pressure measurement.
The EPIC US study confirmed the safety of the FiberNet Embolic Protection Device in carotid artery stenting.
The Jamboxx respiratory therapy device study was terminated, highlighting issues in postoperative pulmonary care.
The ASCEND Study evaluated the safety and efficacy of the Intersect ENT UP Drug-Coated Device in CRS patients.
GE HealthCare's Giraffe™ OmniBed™ may pose patient injury risks due to potential fastener disengagement.
ResMed acquires Noctrix Health for $340 million, focusing on restless leg syndrome treatment.
Medtronic seeks FDA clearance to expand the Hugo RAS system for general and gynecologic surgery.
Insulet has launched an updated Omnipod 5 AID System in the US after receiving 510(k) clearance.
Getein Biotech's T3 Fast Test Kit (Immunofluorescence Assay) is classified as Class B and registered in EUDAMED.
Zirlux by Henry Schein Inc. is classified as Class IIa medical device under EUDAMED.
Zirlux by Henry Schein Inc. is classified as Class IIa medical device with UDI-DI 00304040158142.