MedTech Spectrum

Article Name Regulatory

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

The new manufacturing plant will commence operations by March 2025

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 Organization for Standardization (ISO) 13485:2016 Standard Certification, which is the international standard for quality management systems within the medical device industry, and a requirement for EU regulatory approval.

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

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 (FDA), which enables both remediation and a return to full commercial operations for the most comprehensive infusion system available in the United States.

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

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 clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device under the 510(k) route.

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).

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 Europe. These tests are the first post-transplant monitoring NGS products to be approved under the new, more comprehensive regulation that came into force in May 2022 and confirm Devyser's two NGS products meet the established safety, efficacy, and quality requirements.

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™-Cerebral Amyloid Status (CAS) test, an innovative tool intended to provide physicians with definitive information about Alzheimer's pathology, enabling improved management of cognitive impairments.

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

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.

14th July, 2023

ExThera Medical Receives FDA Approval for OncoBindTM Procedure in Pancreatic Cancer Patients

OncoBindTM IDE Approved to Study Metastatic Cancer

14th July, 2023

AlloSource's ACEConnex™ Fascia Receives FDA Clearance for Hip Labral Reconstruction

First pre-sutured fascia allograft designed for hip arthroscopists to help increase surgeon efficiency and reduce operating room time

12th July, 2023

Getinge recieves US FDA 510(k) clearance for Servo-air® Lite

Getinge announces clearance from the US FDA for Servo-air® Lite, a wall gas independent non-invasive mechanical ventilator.

10th July, 2023

Genesis MedTech Receives Approval for Launch in China for ArtiSential™

Genesis MedTech, a leading medical device company, announced that its ArtiSential™, a revolutionary series of articulating laparoscopic instruments, has successfully obtained approval from the China's National Medical Products Administration (NMPA) for market release.

07th July, 2023

CMS Introduces HCPCS Code for Ultromics EchoGo® Heart Failure, Enhancing HFpEF Detection Access

Ultromics, a leading health technology company advancing a novel approach for detecting heart failure and its phenotypes, announced today the assignment of a new outpatient code by the Centers for Medicare and Medicaid Services (CMS), for its flagship product, EchoGo® Heart Failure. HCPCS code C9786 can now be used for billing artificial intelligence to aid the detection of Heart Failure with Preserved Ejection Fraction (HFpEF). HCPCS code C9786 can now be used for billing artificial intelligence to aid the detection of Heart Failure with Preserved Ejection Fraction (HFpEF).

06th July, 2023

Abbott Receives FDA Approval for World's First Dual Chamber Leadless Pacemaker

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the AVEIR™ dual chamber (DR) leadless pacemaker system, the world's first dual chamber leadless pacing system that treats people with abnormal or slow heart rhythms. With more than 80% of people who need a pacemaker requiring pacing in two chambers of the heart (both the right atrium and right ventricle), the approval significantly increases access to leadless pacing for millions of people across the U.S.[i]

06th July, 2023

MGI's DNBSEQ-T7* Receives Approval for Clinical Use in South Korea

MGI Tech Co. Ltd. (MGI), a company committed to building core tools and technology to lead life science, announced its ultra-high-throughput genetic sequencer DNBSEQ-T7 received the medical device registration certificate from the Korea Ministry of Food and Drug Safety (MFDS).

06th July, 2023