Article Name Regulatory

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


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

OncoBindTM IDE Approved to Study Metastatic Cancer...Read more

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...Read more

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....Read more

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 Pr...Read more

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 ...Read more

06th July, 2023


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