Article Name Regulatory

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


INVO Receives 510(k) FDA Clearance for Expanded Use of the INVOcell Device

INVO Bioscience, Inc. (Nasdaq: INVO) ("INVO" or the "Company"), a commercial-stage fertility company focused on expanding access to advanced treatment worldwide with its INVOcell® medical device and the intravaginal cult...Read more

28th June, 2023


ATCOR Medical Partners with Datacubed Health to Enhance Patient Engagement in Decentralized Clinical Trials

ATCOR and Datacubed Health partner on a novel remote trial solution to integrate digital vascular biomarker patient monitoring within the Datacubed Health Patient Engagement Platform...Read more

27th June, 2023


CXR-AID, Powered by Lunit, Approved for Reimbursement in Japan, Boosting Market Growth

Medical AI solutions, including CXR-AID, officially included in Japanese health insurance reimbursement as a management service fee of imaging diagnosis...Read more

27th June, 2023


Blood safety and availability

Blood transfusion saves lives and improves health, but many patients requiring transfusion do not have timely access to safe blood. Providing safe and adequate blood should be an integral part of every country’s national...Read more

26th June, 2023


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