United States
Medical device market intelligence for United States. Regulatory changes, competitor moves, and procurement trends.
Recent signals
Spine societies urge insurers to reimburse interbody devices for anterior cervical spine surgery.
The TRISCEND study evaluates the safety and efficacy of the Edwards EVOQUE Tricuspid Valve Replacement System.
A study is recruiting to evaluate the CapsoCam® Colon (CV-3) for polyp detection against colonoscopy results.
Tandem plans to file its first tubeless insulin pump with the FDA this quarter.
The FDA has flagged five Class I medical device recalls for May, impacting pacemakers, convenience kits, staplers, and catheters.
The Neuronoff PNS Injectrode F1 study evaluated lumbar nerve stimulation safety and muscle activation in healthy volunteers.
Cala Health's Cala TWO wristband offers a non-invasive treatment for essential tremor, addressing a major healthcare need.
A clinical study evaluated the efficacy of Soliton's RAP device for treating fibrotic scars.
A clinical trial is recruiting to evaluate a photorefraction device for screening ametropia in children aged 3-8.
A study using EEG aims to predict coma emergence through spectral shifts, utilizing a wireless patch device.
A study aims to evaluate the Thermodiag device for non-invasive core temperature measurement in critical care patients.
The UESAD study evaluates its impact on laryngeal symptoms and salivary pepsin in LPR patients.
The ETX-4143 2.0 device study has been completed, focusing on eye pain treatment efficacy and safety.
The study evaluated the accuracy of the X-Trodes system against an FDA-cleared electrophysiology device.
The study evaluates the efficacy of the OrthoApnea NOA® device for obstructive sleep apnea management.
A completed study compared the reliability of three FDA registered allergy skin test applicators for accuracy in testing.
A completed study evaluated CervicalStim's impact on cervical fusion rates in high-risk patients post-surgery.
A completed study evaluated a non-invasive pain measurement device against patient pain ratings.
The AMES robotic device aims to enhance balance recovery in near-frail elderly by improving lower-limb motor control.
The study evaluates the safety and functionality of the SFM Anastomosis Device in various bariatric procedures.