Regulatory

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


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 abnorma...Read more

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 certificat...Read more

06th July, 2023


IMed Consultancy Launches New UKRP-Focused Website for Medical Device Launches in the UK

IMed launches new UKRP resource to inform businesses after surge in demand for UKRP services...Read more

05th July, 2023


SimonMed Imaging Implements 3rd Generation iCAD Breast AI 3.0

At no additional cost to patients ...Read more

03rd July, 2023


Will Indian National Medical Policy Unleash Sector's Full Potential?

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 ...Read more

29th June, 2023


Indian Cabinet approves introduction of National Research Foundation Bill 2023 in Parliament

To strengthen the research ecosystem in the country...Read more

29th June, 2023


Roche Gets FDA Clearance for Additional Alzheimer's CSF Assays, Enhancing Diagnosis and Treatment Decisions

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. T...Read more

28th June, 2023


Artificial Intelligence Breakthroughs

Robots In Medtech

Asia Pacific

Global / International

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