IceCure’s Cryoablation Technology Gets Expanded 510(k) Clearance January 7, 2020 The clearance includes the company’s MultiSense system for treatment of multiple tumors and larger masses. Read More
Polyganics Nabs CE Mark for Dural Sealant Patch January 7, 2020 The approval was based on trial data that showed no cerebrospinal fluid leakages or adverse events. Read More
Nextremity Earns FDA Clearance for TMT Joint System January 7, 2020 The system improves stability and restores the foot’s anatomical arch. Read More
BioNess’ Neuromodulation System Cleared in Europe for Fecal Incontinence January 6, 2020 The device is also cleared in Europe for treating chronic pain and overactive bladder. Read More
FDA Clears FreMon’s Portable Plasma Thawer January 6, 2020 The device preserves coagulation factors in the thawed plasma. Read More
PhotoniCare’s Ear Imaging Technology Gets FDA OK January 6, 2020 The scope directly visualizes fluid contained in the middle ear and can gauge fluid density even in the presence of earwax. Read More
FDA Clears Applied BioCode’s Respiratory Pathogen Diagnostic January 6, 2020 The system is designed for use in moderate to high volume laboratories. Read More
New York AG Forges Deal for Naloxone Nasal Spray Device January 3, 2020 “Starting today, additional companies will be able to gain access to these nasal spray devices,” the AG said. Read More
Masimo Gains Additional FDA Clearance for RD SET Sensor December 31, 2019 The device reduces severe retinopathy neonates. Read More
FDA Reclassifies Electrotherapies for Anxiety and Insomnia December 27, 2019 The agency also requires premarket approval applications for CES devices intended to treat depression. Read More
FDA Approves CryoLife’s Trial for Heart Valve December 26, 2019 The company’s heart valve is the only mechanical valve that is FDA approved and CE Marked for use with significantly less doses of warfarin. Read More
Bayer Gets FDA Expanded Clearance for CT Injection System December 25, 2019 The system flags tumor tissue that may be missed with a standard mammogram. Read More