MedTech News
.................... by Andrew Celentano
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.
Penumbra announces European launch of its most advanced neuro access offerings
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.
FDA Clears Clarius OB AI for Handheld Ultrasound: A Leap Forward in Prenatal Care
The company’s 8th AI model makes ultrasound easier for new ultrasound users to capture important fetal measurements
AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System
Powered by this AI, the Pocket-Sized Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac Conditions