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...
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]...
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)....
IMed launches new UKRP resource to inform businesses after surge in demand for UKRP services...
At no additional cost to patients ...
The National Medical Devices Policy, 2023 that got the approval of the government on April 26 seems to have made the medical devices sector happy. The slew of strategies mentioned in the policy assures a win–win outcome for the manufacturers as well as patients. Experts are upbeat about the projected growth of the sector in the near future. The policy aims to bring a range of interventions in a coherent manner that would facilitate focussed and efficient support and facilitation for the sector b...
To strengthen the research ecosystem in the country...
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Total-Tau CSF assays (tTau) have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and tTau assays (used as a tTau/Abeta42 ratio) measure two biomarkers of Alzheimer's pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease....
