FDA Grants Breast Screening Clearance for Eizo Monitor April 24, 2020 It offers a brightness of up to 1,200 cd/m2, high contrast ratio of 1500:1, and a tight pixel pitch of 0.1554 mm, according to the company. Read More
Bimini Receives FDA Clearance for Fat Transfer Syringe April 24, 2020 The Dermapose system is used for small volume transfers. Read More
Cerus Endovascular’s Intracranial Aneurysm Device Gets CE Mark April 23, 2020 The company plans to launch the product in Europe during the fourth quarter of 2020. Read More
FDA Authorizes COVID-19 Test for At-Home Sample Collection April 23, 2020 Patients mail samples to LabCorp for testing. Read More
PAVmed Earns FDA Clearance for Carpal Tunnel Device April 22, 2020 The device is the first to use catheter, balloon and wire techniques for carpal tunnel procedures. Read More
Hill-Rom Nabs Emergency Use Authorization for Ventilation Device April 22, 2020 The system can help reduce time spent on a ventilator. Read More
TGA Approves Osteopore’s 3D-Printed Scaffolds for Bone Regeneration April 21, 2020 The 3-D printed scaffolds dissolve over time to leave only healthy bone tissue. Read More
Astura Gets 510(k) Clearance for Lumbar Interbody Fusion System April 21, 2020 The Sirion system is the company’s first product that combines interbody and fixation options in a single device. Read More
Endospan’s Aortic Arch-Repair System Gets Breakthrough Designation April 21, 2020 The system allows physicians to repair the aortic arch from the inside. Read More
Nova Biomedical Launches Emergency Blood-Testing System April 20, 2020 The lightweight case fits in a medical bag. Read More
Roche Prepares to Launch COVID-19 Antibody Test April 20, 2020 Roche said it plans to obtain CE mark certification in early May and will seek FDA Emergency Use Authorization as well. Read More
Proteomics International Earns CE Mark for Kidney Disease Test April 17, 2020 The test is the first available in the EU for predicting the onset of diabetic kidney disease. Read More