Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system.
The FDA also accepted the system into...
4D Path has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for Q-plasia OncoReader Breast, its first software-as-a-medical-device solution.
The new 4D...
Front Line Medical Technologies today announced it received CE mark approval for its COBRA-OS device. The CE mark gives EU medical providers access to...
Epitel announced received FDA 510(k) clearance for two new patient-focused brain health offerings. The FDA cleared the Remi remote EEG monitoring system for ambulatory...
Pantheon Vision has completed two pre-submission meetings with the US Food and Drug Administration (FDA) as the company looks to advance its corneal implants...
Lumicell today announced it received FDA approval for its LumiSystem direct visualization system for breast cancer removal.
According to the company, the LumiSystem allows surgeons...
Xstim announced today that it received premarket approval from the FDA for its Xstim spine fusion stimulator device.Irving, Texas-based Xstim designed its capacitively coupled...
Adherium has obtained US Food and Drug Administration (FDA) clearance for the use of its Hailie Smartinhaler with AstraZeneca’s Airsupra and Breztri inhalation devices.
This...
IceCure Medical announced it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver...
