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)....
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....
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....
Cutting-edge technology and high throughput production capacity mark a new milestone in radiation protection gloves manufacturing...
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....
OncoBindTM IDE Approved to Study Metastatic Cancer...
First pre-sutured fascia allograft designed for hip arthroscopists to help increase surgeon efficiency and reduce operating room time...
Getinge announces clearance from the US FDA for Servo-air® Lite, a wall gas independent non-invasive mechanical ventilator....
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....
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 intell...
