Medical device registration is an essential part of ensuring product safety, effectiveness, and quality. This article will introduce the whole process of medical device registration in detail, including pre-application preparation, registration test, clinical trial, establishment of system, application acceptance, approval of registration, issuance of registration certificate and follow-up supervision.

GE HealthCare raised its profit forecasts for 2023 after recording better-than-expected financials in its Q2 earnings report.

Danaher reported on Tuesday that its second quarter revenues fell approximately 8 percent year over year due to ongoing declines in COVID-related product demand and a drop in biotechnology business revenues.

Chinese IVD instruments market grows from RMB 10.12 billion to RMB 22.32 billion by 2020 from 2016 to 2020, at a CAGR of 21.9%. Stimulated by favorable national policies and the growing demand, it is expected to reach RMB 60.99 billion in 2025 and RMB 114.62 billion in 2030, growing at a CAGR of 22.3% and 13.4% during the periods 2020-2025 and 2025-2030, respectively.

DiaCarta said Monday that it has formed a strategic partnership with New Jersey-based contract research organization Hopkins MedTech Compliance/Hopkins MedTech Lab Services to provide validation and regulatory compliance services for laboratory test and in vitro diagnostic developers in the US.

QuidelOrtho Corporation, a global provider of innovative in vitro diagnostics technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has entered into a software development partnership with BYG4lab®, a leading provider of middleware and data management solutions for laboratories, that intends to accelerate QuidelOrtho’s efforts to expand and strengthen informatics offerings across its portfolio of diagnostics platforms.

On July 19, 2023, the Third People’s Hospital of Shenzhen (hereinafter referred to as Shenzhen Third Hospital) and Shenzhen New Industries Biomedical Engineering Co., Ltd. (hereinafter referred to as Snibe) successfully held an exchange seminar and a signing ceremony of strategic cooperation on “Industry-University-Research-Hospital-Application”.

Invivoscribe is excited to announce that the LeukoStrat CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo’s VANFLYTA® (quizartinib).

Abbott today announced financial results for the second quarter ended June 30, 2023.

On July 19, Mindray and Beijing Strong Biotechnologies, Inc. (hereinafter referred to as BSBE) held a strategic cooperation signing ceremony at Mindray's headquarters in Shenzhen.

Next-generation sequencing data analysis platform company One Codex said on Thursday that it has formed a partnership with Swiss clinical product manufacturer 4bases to bring sample-to-report microbiome analysis solutions to clinicians in the EU.

Siemens Healthineers said Thursday that it has received US Food and Drug Administration clearance for an analyzer designed for immunoassay and clinical chemistry testing in low- to medium-volume laboratories.

Thailand is a country with a high prevalence of thalassemia and sickle-cell anemia, and the related hemoglobinopathies have become a prominent problem in Thailand's public health.

Home health testing company SiPhox Health announced on Wednesday that it has raised $10 million in a seed financing round and $17 million in a Series A round.

AACC has announced that it is changing its name to the Association for Diagnostics & Laboratory Medicine (ADLM).