EmpNia Earns FDA Clearance for Respiratory Device

Mendaera earns FDA clearance for Focalist handheld robotic system - The Robot Report

Focalist is designed to be accessible across specialties and to help meet the growing demand for needle-based interventions. | Source: Mendaera Mendaera Inc. today announced that it has received U.S. Food and Drug Administration 510(k) clearance for its Focalist handheld robotic system. The San Mateo, Calif.-based company said it designed Focalist to simplify and enhance the precision of ultrasound-guided needle placement — a technically demandi…

EmpNia Earns FDA Clearance for Respiratory Device

Minneapolis-based medical device innovator EmpNia has been granted clearance by the Food and Drug Administration (FDA) to market its wearable sensor, eMotus, to hospitals and cancer centers across the U.S. The company’s eMotus system is designed to help manage image-guided radiation therapy—specifically, for cancer patients. EmpNia’s team of medical professionals saw an opportunity to improve upon existing solutions, which they said can be hard …

Sirtex Medical granted FDA approval for SIR-Spheres - Interventional News

Sirtex Medical has today announced that is has received US Food and Drug Administration (FDA) approval for its SIR-Spheres Y90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the USA. With this approval, SIR-Spheres is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the USA. HCC is the most common form of liver cancer in adult…