Company Product Description Indication Status
Airos Medical Inc., of Audubon, Pa. Airos 6  Sequential compression device and related accessory garments, including the Arm Plus  Treats lymphedema in the arm, shoulder, chest, and back Received 510(k) clearance from the U.S. FDA
GE Healthcare, of Chicago Air Recon DL Imaging technology that uses  a deep learning-based neural network For magnetic resonance image reconstruction Received 510(k) clearance from the U.S. FDA
Gynesonics Inc., of Redwood City, Calif. Sonata system 2.1 Intrauterine ultrasound system with a radiofrequency ablation device For transcervical fibroid ablation Received 510(k) clearance from the U.S. FDA
Quest Diagnostics Inc., of Secaucus, N.J. Quest Diagnostics Self-collection Kit for COVID-19 Self collection tube and nasal swab For individuals to self-collect a nasal specimen; specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test Received emergency use authorization from the U.S. FDA 


For more information about individual companies and/or products, see Cortellis.

No Comments