Regulatory Approvals

Cerus Corporation has obtained CE mark approval for its INT200, a light-emitting diode (LED)-based illumination device, for the Intercept Blood System for platelets and...

Phantom Neuro today announced it received FDA breakthrough device designation and Targeted Acceleration Pathway (TAP) designation for its minimally invasive neural interface Phantom X. The...

Penderia Technologies, a company developing wireless sensor technologies for orthopedic applications and in collaboration with MRC Global, LLC, recently received the FDA’s Breakthrough Device...

ABANZA, a leader in advanced soft tissue repair solutions, shared the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative...

Averto Medical, a clinical-stage medical device company pioneering minimally invasive gastrointestinal care, is pleased to announce that the U.S. Food and Drug Administration (FDA)...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the BioCharge Autobiologic Matrix, a bioresorbable synthetic implant developed by startup Atreon...

CathVision has gained the CE Mark certification for its ECGenius system, enabling the company to market and distribute the system throughout the European Economic...

QuantalX Neuroscience has gained the European CE Medical Device Regulation (MDR) approval for the Delphi-MD, a device for assessing brain health. With this certification in...

Neuvotion received FDA 510(k) clearance for its first product, the NeuStim wearable device. The company designed NeuStim to electrically stimulate muscles dynamically and with...