The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was accorded a mere 60 days for comment, but nonetheless drew support from a number of stakeholders, including Foundation Medicine of Cambridge, Mass.
The U.S. FDA’s advisory hearing on multi-cancer detection (MCD) tests suggests that the premarket requirements for these tests will be rigorous, if only because the agency stated at the outset of the hearing that it sees these tests as class III devices. However, the advisory committee also suggested that a registry be established to track outcomes for these tests, a requirement that is likely to prove expensive and time-consuming to fulfill.
On Dec. 1, a judge in the U.S. District Court for the District of Delaware granted Natera Inc. a permanent injunction in its patent infringement suit against Archerdx Inc. and its former parent company, Invitae Corp., adding another block to the intellectual property wall of protection around the market dominance of Signatera, Natera’s molecular residual disease (MRD) assay.
Researchers at the University of California, Davis (UC Davis) have developed a method of biofluid assessment capable of real-time monitoring as well as compatible with machine learning and neural network processing.
Brainspec Inc. received U.S. FDA 510(k) clearance for use of its artificial intelligence platform, Brainspec Core, in noninvasive measurement of brain chemistry using magnetic resonance spectroscopy (MRS).
Inflammatix Inc. received U.S. FDA breakthrough device designation for its Triverity acute infection and sepsis test system, which produces three readouts that could help emergency physicians quickly determine the proper course of treatment.
The Cari-Heart, a medical imaging technology which detects signs of inflammation around coronary arteries, can predict the risk of a cardiac event, independent from clinical risk scores and the interpretation of coronary computed tomography angiography (CCTA), according to data from a study presented at the recent American Heart Association Scientific Sessions.
South Korean researchers from the Gwangju Institute of Science and Technology (GIST) developed a new fluorescence-based lateral-flow immunoassay (LFI) enhanced with gold nanorod (GNR)-based probes to detect viral infections like the influenza A virus.
The time to diagnosis of sepsis infection to a patient in the hospital can be critical, with underdiagnosis resulting in rapid deterioration, risk of organ damage and need for readmission, and overdiagnosis leading to the avoidable and sometimes serious health consequences of overtreating patients with broad-spectrum antibiotics.
Siemens Healthineers AG appears to be committed to its Diagnostics business after Jochen Schmitz, CFO, pushed back at rumors speculating that the German company was looking at options for the underperforming segment, including a sale.
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