Article Name Regulatory

Inspira™ Technologies Receives Medical Devices Quality Certification, Progresses Towards EU Regulatory Approval

Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a company aiming to revolutionize acute respiratory care, is proud to announce it has received International Organiza...Read more

25th July, 2023

Nesa Medtech gets US FDA clearance for fibroid mapping reviewer application

Novel SaMD technology generates a 3D model of uterus to facilitate treatment in patients with symptomatic uterine fibroids...Read more

25th July, 2023

BD Receives FDA 510(k) Clearance for Updated BD Alaris™ Infusion System

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced that the updated BD Alaris™ Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration...Read more

24th July, 2023

Essentials of ensuring cybersecurity in the IoMT and telemedicine landscape

Jess Ng, Country Head of Singapore and Brunei at Fortinet, unravels best practices to mitigate cyber security risks in the healthcare, clinical and pharma ecosystem...Read more

24th July, 2023

Aevice Health's Smart Wearable Stethoscope Receives US FDA Clearance for Remote Respiratory Monitoring Platform

Aevice Health, a leading provider of remote respiratory monitoring solutions for the healthcare continuum and backed by the Cedars-Sinai Accelerator, announced that its flagship medical device, the AeviceMD, has received...Read more

21st July, 2023

FDA Clears ReddyPort® Non-Invasive Ventilation Device

ReddyPort announced that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV)....Read more

19th July, 2023

Devyser's NGS Products for Kidney Transplants Get IVDR Approvals

Devyser's novel test for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplanted patients fulfill IVDR requirements in...Read more

18th July, 2023

Optina's REPHRASE Study Validates Innovative Alzheimer's Test

Optina Diagnostics' pioneering pivotal REPHRASE study, currently underway, is poised to revolutionize the diagnosis and management of Alzheimer's Disease (AD). This landmark study is focused on validating the novel awAIr...Read more

18th July, 2023

Trivitron unveils India's first automatic radiation protection gloves manufacturing facility at AMTZ

Cutting-edge technology and high throughput production capacity mark a new milestone in radiation protection gloves manufacturing...Read more

18th July, 2023

Medical Device Supply Chain Service Provider GKHT Medical Goes Public Successfully

On July 12, Legend Capital's portfolio company, GKHT Medical Technology Co., Ltd. ("GKHT Medical"; Stock Code: 301370.SZ), was successfully listed on the ChiNext Market of the Shenzhen Stock Exchange....Read more

14th July, 2023

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