Thermo Fisher Scientific has expanded its analytical instrument portfolio with the introduction of three new medical devices for clinical diagnostic laboratories.
The US Food and Drug Administration (FDA) has listed Thermo Fisher’s new systems as class I medical devices.
New class I medical devices introduced by Thermo Fisher
Part of Thermo Scientific Medical Device (MD) portfolio of liquid chromatography-mass spectrometry (LC-MS) systems, the new products include the single-channel Thermo Scientific Vanquish MD High Performance Liquid Chromatography (HPLC) system, Thermo Scientific TSQ Altis MD Series mass spectrometer with enhanced sensitivity and Thermo Scientific Quantis MD Series mass spectrometer for routine testing.
The new systems compliment the existing dual-channel Thermo Scientific Prelude MD HPLC and four-channel Thermo Scientific Prelude LX-4 MD HPLC systems, helping to create a complete MD portfolio of analytical solutions.
Thermo Fisher’s comprehensive platforms allow clinical laboratories to accomplish their desired sensitivity and throughput goals while conforming to in vitro diagnostic (IVD) regulations.
Through a complete suite of LDT-enabled software with a laboratory information system (LIS) option, the analytical solutions will improve the performance of laboratory developed tests (LDTs).
The enhanced product portfolio will also help increase the throughput of clinical diagnostic assays to detect small to large molecules within complex biological matrices.
Thermo Fisher is exhibiting its MD portfolio at the 71st American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Laboratory Exposition (AACC 2019), which is being held between 4 and 8 August in California.
Thermo Fisher Scientific clinical marketing, chromatography and mass spectrometry senior director Bradley Hart said: “Clinical laboratories need the ability to develop and optimize sensitive and reliable laboratory developed tests that are crucial in the diagnosis and monitoring of acute and chronic diseases.
“With the new MD portfolio of Class I medical devices listed with the U.S. FDA, scientists in clinical diagnostic laboratories can now choose from a unique portfolio of liquid chromatography and mass spectrometry platforms to develop assays essential for clinical decision-making.”
In January this year, PHC Holdings agreed to acquire anatomical pathology business from Thermo Fisher Scientific for around $1.14bn (£936m). – NS Medical Devices