Medtronic expects sales in China of the Symplicity Spyral blood pressure treatment to “be modest in the short-term.” ...

San Jose, California-based Outset is competing in the market for dialysis equipment. Its Tablo hemodialysis system can be used in acute or chronic care facilities and was cleared for home use in 2020.

CMR Surgical has appointed Shlomi Cohen as CFO as the maker of the Versius surgical robot continues to scale up its operations, the company said Tuesday. Cohen, whose appointment is effective ...

Karius plans to use the funding to expand the test outside of the hospital setting and support research of the company’s DNA technology beyond infectious diseases.

Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices.

No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.

QuidelOrtho has appointed Brian Blaser as CEO, the company said Thursday. Blaser is coming out of retirement to take charge of QuidelOrtho about two months after the in vitro diagnostics company fired ...

Cue has gone through several rounds of layoffs as the testing company looks to control costs. In January, the company cut more than 200 positions across two rounds of layoffs, and Cue also slashed ...

The Food and Drug Administration’s final rule solidifying its authority over laboratory developed tests (LDTs) marks a major shift in the regulation of the diagnostics industry. The rule makes clear ...

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The Phase 3 study demonstrated strong superiority in visualization of focal liver lesions with Orviglance (CMRI) vs. unenhanced MRI with statistical significance for all three readers (<0.001) ...