Article Name Regulatory

A dispute between industry & government's opinion on medtech sector?

Unfortunate to see PM’s ‘Make in India’ dream being bulldozed: AiMeD...Read more

01st August, 2023


icotec ag's VADER® Pedicle System Navigated Instruments Gain FDA 510(k) Clearance for Safer Spinal Implantation

icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is pleased to announce the receipt of FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. This ...Read more

28th July, 2023


RIVANNA Secures $30.5M from BARDA to Advance Accuro XV Musculoskeletal Imaging

Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software....Read more

28th July, 2023


Beckman Coulter's DxC 500 AU Chemistry Analyzer Receives FDA Clearance

Beckman Coulter Diagnostics, a clinical diagnostics leader, received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company's clinical chemistry offering and demo...Read more

26th July, 2023


Japan's Omron Healthcare breaks ground on new manufacturing plant in India

The new manufacturing plant will commence operations by March 2025...Read more

26th July, 2023


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


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