FDA OKs Abbott’s Implantable Heart Rhythm Devices July 7, 2020 The two devices enable remote monitoring by using Bluetooth technology to communicate with smartphone apps, the company said. Read More
FDA Approves Cochlear’s Off-the-Ear Sound Processor July 7, 2020 According to the company, the device is the world’s smallest off-the-ear cochlear implant. Read More
Becton Dickinson Earns EUA for Point-of-Care COVID-19 Test July 7, 2020 The assay delivers test results within 15 minutes and does not require laboratory personnel, according to the company. Read More
FDA Clears Engage Surgical’s Cementless Partial Knee System July 6, 2020 The device will initially be available to orthopedic surgeons at the Hospital for Special Surgery and affiliated surgical centers. Read More
KDx Diagnostics Earns CE Mark for Bladder Cancer Test July 6, 2020 Bladder cancer has a high recurrence rate that requires frequent retesting. Read More
Venus Concept Snags 510(k) Clearance for Skin Rejuvenation Device July 6, 2020 The company plans a limited launch of the product by the end of the third quarter. Read More
FDA Issues Emergency Use Authorization for Centogene’s COVID-19 Assay July 6, 2020 The test is intended for use in the company’s high-complexity laboratories in Germany. Read More
Kardium Earns CE Mark for Globe Mapping and Ablation System July 2, 2020 Kardium has formed a subsidiary in Germany to handle commercial sales of the system in Europe. Read More
Kroger’s COVID-19 Test Home Collection Kit Cleared for Emergency Use July 2, 2020 The agency said promotional material for the home collection kit must make clear that it has not been FDA cleared or approved. Read More
Masimo Earns De Novo Classification for Opioid Withdrawal Device July 1, 2020 The device is applied to patients by a healthcare professional in a nonsurgical procedure. Read More
CoreLink’s 3D-Printed Cervical Spine System Cleared July 1, 2020 The device does not require a supplemental fixation plate, making the surgeries its used in simpler and faster. Read More
FDA Clears Orthofix’s Bone-Screw System for Sacroiliac Joint Dysfunction June 30, 2020 The system is implanted during a minimally invasive surgery that takes about an hour. Read More