Roche Diagnostics launches cervical cancer screening lab in India

India – Roche Diagnostics launches cervical cancer screening lab in India

Cancer Institute (WIA) launched a molecular lab for cervical cancer screening on Wednesday. Roche Diagnostics India that provides in-vitro diagnostics solutions launched its HPV (Human...
S. Korean devicemaker debuts AI-based diagnostics platform

South Korea – S. Korean devicemaker debuts AI-based diagnostics platform

JLK Inspection, a member company of the K-ICT Born2Global Centre, is introducing its latest AI-based medical image diagnosis system, the AIHuB, a cutting-edge all-in-one...
European Regulators Publish UDI Guidance |

Europe – European Regulators Publish UDI Guidance

The Basic UDI-DI is the key identifier of a device in Eudamed, on certificates and on the Declaration of Conformity. Multiple UDI-DIs can...
Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

USA – Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

US FDA is considering adoption of ISO 13485:2016 quality system requirements for medical device registrants. ISO 13485 would replace FDA Quality System Regulations...
China FDA Reorganization: Impact for medical device registrants

China – China FDA Reorganization: Impact for medical device registrants

The China Food and Drug Administration (CFDA) is being reorganized into the China Drug Administration (CDA). A new State Administration for Market Supervision...
Beta Bionics Wins Readers' Choice for Medtech Company of the Year

International – Beta Bionics Wins Readers’ Choice for Medtech Company of the Year

The people have spoken. Beta Bionics has been named medtech company of the year. Nearly 44% of MD+DI readers participating in a special poll voted for...
Predict and Prevent: The Emergence of Real-Time Sensor-Based Care

International – Predict and Prevent: The Emergence of Real-Time Sensor-Based Care

echnology industry veteran Eran Ofir knows there is a lot of luck involved in successfully bringing a new device, especially one designed to create...
Essure Discontinuation Doesn't Mean the End to FDA Scrutiny

USA – Essure Discontinuation Doesn’t Mean the End to FDA Scrutiny

FDA wants the public to know it is taking steps to make sure the long-term safety profile of a controversial birth control device continues...
FDA Reclassifies Some ECT Devices

USA – FDA Reclassifies Some ECT Devices

Electroconvulsive therapy (ECT) devices used for the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder...
Health Canada Details Medical Device Action Plan

Canada – Health Canada Details Medical Device Action Plan

Health Canada issued a new action plan on Thursday, detailing a three-part strategy intended to improve safety, oversight and quality in the Canadian medical...

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