Asuragen Gets CE Mark for Spinal Muscular Atrophy Assay July 8, 2020 The polymerase chain reaction test delivers results in four hours. Read More
Medtronic Earns Clearances for Insertable Cardiac Monitor July 8, 2020 Patients can send data from the device using a smartphone app or a home communicator device. Read More
Novartis’ Asthma Med, Inhaler and Sensor Cleared in Europe July 8, 2020 The optional sensor can deliver data via a smartphone app. Read More
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