MedTech News
CeQur wins FDA nod for mealtime insulin delivery device
Each patch now replaces up to 12 mealtime injections, equaling more than 1,000 fewer injections annually, according to a news release.
Researchers develop an alternative to pacemakers in the form of a hydrogel
A heart attack is a life-threatening condition, with patients remaining at risk of premature death long after the actual attack—50% to 60% of patients die subsequently as a result of sudden cardiac death, triggered by cardiac arrhythmia.
FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test
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.
MicroVention launches new stent in the U.S.
Terumo subsidiary MicroVention announced that it began the U.S. launch for its LVIS EVO intraluminal support device.
MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software
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 announces CE marking for COBRA-OS
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.
Starpax Biopharma Never-Before-Seen Magnetodrones™ and PolarTrak® Technology Transform Cancer Treatment
https://www.prnewswire.com/news-releases/starpax-biopharma-never-before-seen-magnetodrones-and-polartrak-technology-transform-cancer-treatment-302181096.html
Ikerian (parent company of RetinAI U.S. Inc.) receives EU-MDR Certificate for four devices, its Ophthalmology Data Platform and AI models
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.