FDA Green Lights Mar Cor Purification’s Dialysis Water Disinfectant January 16, 2015 The biodegradable disinfectant is made of peracetic acid and hydrogen peroxide. Read More
Signostics Gets FDA Nod for Portable Ultrasound Bladder Scanner January 16, 2015 The easy-to-carry device can help reduce UTIs during catheterization. Read More
Valorem Surgical’s Spinal Fixation System Gets FDA OK January 14, 2015 The company also announced the first clinical use of the device. Read More
BiO2 Medical Gets FDA Nod to Start IDE Trial of Its Angel Catheter January 13, 2015 The trial will study the catheter’s ability to prevent pulmonary embolisms. Read More
Tandem Diabetes Care Gets FDA Go-Ahead for Large-Capacity Insulin Pump January 13, 2015 At 480 units, t:flex is the largest pump available in the U.S. Read More
Intact Medical Gets Expanded 510(k) Clearance for Intact System January 12, 2015 The new clearance allows for the ability to preserve breast lesion architecture. Read More
HGI Industries Gets FDA Clearance for Medical Facility Air Purifier January 9, 2015 The Odorox MDU/Rx uses UV rays to reduce microorganisms found in the air. Read More
PorOsteon Wins FDA Nod for Phusion Metal Cervical Cage January 9, 2015 The cage is designed to spur bone growth and mimic natural bone. Read More
FDA Green Lights Roche’s Blood and Plasma Donation Assay January 9, 2015 The TaqScreen MPX Test, v2.0 tests for HIV and Hepatitis B and C. Read More
Myriad Genetics Gets CE Mark for BRCA 1/2 Tumor Test January 8, 2015 The Tumor BRACAnalysis CDx identifies patients who may benefit from a specific anticancer therapy. Read More
NeuroSigma’s Monarch eTNS Device Granted Humanitarian Designation January 7, 2015 The pulse therapy is used to treat a rare childhood brain disorder. Read More
FDA Green Lights Suneva’s Acne Scar Treatment January 7, 2015 The collagen-based Bellafill raises and smooths acne scars on the cheeks. Read More