Medtech Spectrum: Discovering the Intersection of Medical Technology and Healthcare Advancements

Article Name Regulatory

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

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