Large Hydroxychloroquine Study Gets Under Way
Enrollment for a large, global trial of chloroquine and hydroxychloroquine for the prevention of COVID-19 is getting under way in the United Kingdom. Source: Devices & Diagnostics Letter
BioMérieux’s COVID-19 Antibody Tests Obtain CE Mark
The presence of antibodies in a patient means that they likely had COVID-19 at some point and may suggest they have some degree of immunity. Source: Devices & Diagnostics Letter
Fujifilm Begins Research on AI Tech for COVID-19 Pneumonia
The company is involving local Japanese medical institutions in its project, beginning with Yokohama’s Kanagawa Cardiovascular and Respiratory Center. Source: Devices & Diagnostics Letter
Baxter Earns CE Mark for Syringe-Infusion System
The device should be available in Europe, Australia and New Zealand in June. Source: Devices & Diagnostics Letter
New Jersey Contract Tester Warned for API Testing Violations
The FDA hit a Paterson, New Jersey contract testing laboratory with a warning letter for active pharmaceutical ingredient (API) testing violations. Source: Drug Industry Daily
Europe’s MDCG Releases Guidance on Class 1 Transitions Under MDR
The EU’s Medical Device Coordination Group released a guidance for devicemakers on transitional provisions for Class I devices under the Medical Device Regulation (MDR). Source: The GMP Letter
FDA Wants Proof of Reliability for Emergency-Use Injectors
The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Source: The GMP Letter
TGA Fines Oxymed Australia for COVID-19 Advertising Claims
Australia’s Therapeutic Goods Administration (TGA) fined Oxymed Australia A$63,000 ($40,000) for making false claims that its hyperbaric oxygen therapy chambers can treat a variety of conditions, including COVID-19. Source: The…
483 Roundup: Six Devicemakers Rapped for Quality Lapses
The FDA cited six U.S. devicemakers for a variety to quality failures including failing to submit medical device reports or to maintain a device master record. Source: The GMP Letter
FDA Loosens Regulations on Digital Pathology Devices During Outbreak
To expand their availability during the pandemic, the FDA has temporarily relaxed its regulations on the use of certain digital pathology devices in laboratories. Source: The GMP Letter
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