Bioneer Gains CE Mark for HIV-1 Kit October 9, 2018 The kit is used to count the presence of HIV-1 RNA in patient blood samples. Read More
Webinar: Strategies for Getting Your De Novo Device Approved October 8, 2018 In terms of data requirements and FDA review time, the de novo pathway typically falls between the 510(k) and the PMA. Read More
FDA Approves Zeiss Treatment for Astigmatisms October 8, 2018 The laser device creates a lenticule and incision inside the cornea in a single step. Read More
Eximo Medical’s Atherectomy Laser Cleared by FDA October 8, 2018 Atherectomies can be chosen as alternatives to angioplasties. Read More
Minimal Residual Disease Assay for Leukemia Patients Cleared by FDA October 3, 2018 The assay tests for MRD by identifying and counting gene sequences in DNA extracted from the patient’s bone marrow. Read More
Acessa Health Cleared for Uterine Fibroid Ablation Device October 3, 2018 The minimally-invasive procedure the device is capable of performing has been clinically proven to be a safe alternative to hysterectomy. Read More
Applied BioCode Cleared to Market New Diagnostic Device October 2, 2018 The device uses a magnetic bead barcode technology to improve cost effectiveness and readings. Read More
Xtreem Pulse’s Rapid Pulse Compressor Gains CE Mark October 2, 2018 The device’s pumping action helps to send oxygen and nutrients into cells. Read More
Kheiron’s Breast Cancer Screening Software Receives CE Mark October 2, 2018 The screening software uses artificial neural networks to evaluate complex medical images. Read More
Abbott’s Sensor-Based Glucose Monitor Gains CE Mark October 1, 2018 The glucose monitor uses Bluetooth technology with its new alarm feature to alert patients when they have low or high glucose levels. Read More
TransEnterix’s Ultrasonic Instrument Cleared in EU October 1, 2018 The device can be used for a wide range of procedures. Read More
Sensile Medical Micropump Gains CE Mark September 28, 2018 The micropump can deliver a bolus with the press of a button. Read More