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The FDA has issued final guidance that details what information should be included in premarket submissions to show electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions and sensors. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) said it is now accepting all presubmissions for in vitro diagnostics (IVDs), including non-COVID-19-related products, effective June 1. Read More
Two lines of Becton Dickinson (BD) devices that rely on software can be hacked relatively easily, the U.S. Cybersecurity and Infrastructure Security Agency said, deeming both to be vulnerable to “low-attack complexity.” Read More
San Diego, Calif.-based Quidel has completed its $6 billion acquisition of Ortho Clinical Diagnostics, creating what the newly merged company, QuidelOrtho, calls a “balanced and diversified” portfolio of diagnostic instruments and assays. Read More
Guardant Health has moved to dismiss a lawsuit Illumina filed against it for allegedly stealing trade secrets relating to next-generation sequencing oncology tests. Read More
A proposed in vitro clinical test (IVCT) reform bill that may end up in the fifth iteration of the Medical Device User Fee Act (MDUFA) is generating pushback from industry groups and academia. Read More
Ethicon, a Johnson & Johnson medtech company, has lost its appeal of a patent claim it filed against Intuitive Surgical over an endoscopic surgical stapling device. Read More
Seattle, Wash.-based Magnolia Medical Technologies said the FDA is satisfied with the steps it took to correct violations the agency identified in a warning letter to the company last year and has sent a “close-out notification.” Read More
The EU’s Medical Device Coordination Group (MDCG) clarifies in a new guidance that seemingly minor changes can make it necessary for a device manufacturer to assign a new UDI-DI to a product. Read More
Devicemakers are asking for more time to implement the FDA proposed rule that aims to harmonize the agency’s Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485 standard. Read More
San Diego, Calif.-based Illumina has secured a CE mark in Europe for its TruSight Oncology (TSO) comprehensive assay that can now be used as a companion diagnostic to identify cancer patients with a rare gene mutation for treatment with Bayer’s Vitrakvi (larotrectinib). Read More
Boston Scientific’s Acurate neo2 transcatheter heart valve showed a “significantly lower” frequency of cardiac complications than earlier versions of the device, Italian researchers reported in the journal of the American College of Cardiology. Read More