SILVER SPRING, Md., June 27, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C.

Terumo subsidiary MicroVention announced that it began the U.S. launch for its LVIS EVO intraluminal support device.

WASHINGTON, June 26, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in aiding CamDiab’s artificial pancreas software, CamAPS FX, in achieving U.S. Food and Drug Administration (FDA) clearance.

Front Line Medical Technologies has announced that its COBRA-OS (Control Of Bleeding, Resuscitation, Arterial Occlusion System) has officially been granted CE marking under the new European Medical Device Regulations.

https://www.prnewswire.com/news-releases/starpax-biopharma-never-before-seen-magnetodrones-and-polartrak-technology-transform-cancer-treatment-302181096.html

Bern & Boston, US, June 24th, 2024 – Ikerian AG (“Ikerian”) a leader in developing software solutions for medical image and data management and artificial intelligence (AI) in healthcare, today announced the registration as Class IIa medical devices under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR) of 4 devices.

Penumbra has announced the CE Mark and European launch of BMX81 and BMX96. These devices are designed for neurovascular management of ischemic and hemorrhagic stroke and are Penumbra’s most advanced neuro access offerings.

The company’s 8th AI model makes ultrasound easier for new ultrasound users to capture important fetal measurements