United States
Medical device market intelligence for United States. Regulatory changes, competitor moves, and procurement trends.
Recent signals
Baxter recalls Cefazolin in Dextrose Injection due to particulate matter contamination in the solution.
Cook Incorporated's Universa® device is classified as Class IIB in EUDAMED with UDI-DI 00827002498884.
Edwards' TAVR business drove Q2 revenues to $1.26bn, prompting an uplift in FY26 growth outlook.
Velmeni received FDA 510(k) clearance for its V4D 3D software, enhancing dental technology in the US market.
A smart ring developed at UC San Diego monitors glucose, ketones, and other biomarkers from sweat continuously.
A study on a pulsed radiofrequency device for diabetic neuropathy pain shows potential for pain relief and improved function.
Edwards anticipates strong TAVR sales due to potential Medicare coverage expansion for transcatheter aortic valve devices.
AI enhances healthcare supply chains by improving visibility and efficiency, not replacing procurement teams.
Boston Scientific's ENROUTE systems may experience arterial sheath tip separation during use.
Fractyl Health is shifting focus to help former GLP-1 users maintain weight loss with a new endoscopic procedure.
Wellumio raised $9.75M to commercialize its Axana portable brain imaging device for acute stroke detection.
The Universa® device by Cook Incorporated is classified as Class IIB and has a UDI-DI of 00827002498938.
Cook Incorporated's Universa® device is classified as Class IIB and registered in EUDAMED.
Cook Incorporated's Universa® device is classified as Class IIB and has a UDI-DI of 00827002498860.
Cook Incorporated's U020302 device is classified as Class IIB and registered in EUDAMED.
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.