Voluntis’ Digital Cancer App is CE Marked November 17, 2020 The app issues alerts when escalation of care is needed. Read More
Ortho Clinical Earns CE Mark for Thyroid Disorder Assay November 17, 2020 The assay delivers results in 24 minutes. Read More
Australia Rolls Out Online ‘Dashboard’ for Postmarket Reviews November 16, 2020 The agency has posted a compliance guide on its website with step-by-step instructions on how to use the dashboard. Read More
GE Healthcare Nabs FDA Clearance for MRI Scanner November 16, 2020 The scanner can reveal abnormalities that aren't detected using MRI scanners with lower magnet strengths. Read More
Lantheus Gets FDA Clearance for Automated Bone Scan Solution November 16, 2020 The software has been trained to automate the detection of hotspots in bone that indicate metastatic disease. Read More
SafKan Health’s Automated Ear Cleaning Device Cleared November 16, 2020 The company said that it is developing a consumer version of the device that can be used in the home to prevent excessive earwax buildup. Read More
Nanowear’s Cloth-Based Monitoring System Earns 510(k) Clearance November 13, 2020 The company said it plans to continue its trials assessing the device as a tool for diagnosing worsening heart failure and COVID-19. Read More
Stryker Wraps Up $4 Billion Buyout of Wright Medical November 13, 2020 To secure FTC approval for the deal, Stryker had to offload certain assets to Maryland-based Colfax. Read More
HeartHero’s Automated External Defibrillator Receives CE Mark November 13, 2020 The device is small enough to fit in a purse or backpack and can automatically contact emergency services to shorten response times. Read More
NovoCure Earns CE Mark for Electrical Field Cancer Treatment November 13, 2020 The tumor-treating electric fields of the device cause minimal damage to healthy cells, the company said. Read More
Sientra Picks Ron Menezes as New President and CEO November 12, 2020 Sientra’s aesthetic products include BioCorneum, a scar gel for plastic surgeons. Read More
Biocartis’ COVID-19 RNA Diagnostic Gets CE Mark November 12, 2020 The test provides results in 90 minutes, using a single cartridge, and takes less than two minutes of hands-on time, the company said. Read More