The US Food and Drug Administration in August approved its first mass spectrometry (MS) diagnostic for clinical microbiology use. The VITEK MS, manufactured by the French multinational bioMérieux, based in Marcy-l'Etoile, uses matrix-assisted laser desorption/ionization time-of-flight MS to analyze the proteins of microorganisms and compare them to its vast database of signature profiles. In conventional microbial identification, microbes isolated from patients are subjected to more expensive and slower biochemical and molecular assays before clinicians can act on the information. Given a pure culture of a bacterium or fungus, the VITEK MS can pinpoint its identity at the species level in minutes, with the ability to perform nearly 200 tests at once. The platform is already approved for use in Europe and other countries, but was finally cleared in the US through the de novo pathway, which is used for low-risk devices of a new type that would not warrant premarket approval. A very similar rival platform, the Biotyper from Billerica, Massachusetts–based Bruker, is right behind bioMérieux, with a 510(k) application pending. According to Estée Torok of Addenbrooke's Hospital, Cambridge, UK, who uses the Bruker Biotyper, the technology has revolutionized microbe identification in the diagnostic laboratory. At a fraction of the price per identification of older methodology and producing comparable results, MS-based devices like VITEK and Biotyper, Torok predicts, may one day supplant the traditional identification workflow in most clinical settings.