Israel – New study use musical tests for early detection of cognitive decline
“Our method enables routine monitoring and early detection of cognitive decline in order to provide treatment and prevent rapid, severe deterioration,” said the researchers...
International – IMDRF guidance updates thinking on personalized medical devices
The International Medical Device Regulators Forum (IMDRF) says personalized medical devices (PMD) come in three varieties that require different regulatory approaches. As certain technologies...
International – Enfin une norme internationale sur le dosage des EEB spécifique aux DM...
La série de normes ISO 11737, qui décrit les méthodes microbiologiques associées à la stérilisation des produits de santé, se déclinera dorénavant en trois...
International – Des valves cardiaques imprimées en 3D
Une équipe internationale germano-australienne a mis au point des valves cardiaques artificielles imprimées en 3D, conçues pour permettre aux propres cellules d’un patient de...
International – FDA warns Philips about imaging device violations at China facility
The US Food and Drug Administration (FDA) has warned Philips about manufacturing violations at the company’s facility in Suzhou, China, where computed tomography (CT)...
South Africa – South African regulators issue guidance for medical device imports, advertising
The South African Health Products Authority (SAHPRA) has issued several new regulatory documents that medical device and in vitro diagnostic (IVD) device manufacturers should...
International – IMDRF guidance aims to harmonize, streamline review reports
The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory reporting requirements across jurisdictions. The document lays out expectations not...
International – IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback
Communication between manufacturers and healthcare providers is key to ensuring patients with legacy medical devices are kept safe according to proposed cybersecurity guidance from...
International – IMDRF publishes updated guides covering governance activities and membership
The International Medical Device Regulators Forum (IMDRF) recently posted a series of updated guidelines on the group’s standard operating procedures (SOP), criteria for joining,...
International – Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly identified 10...
