After years of battling to retain its hold on Grail Inc., Illumina Inc. finally announced that it will be unwinding the ill-fated acquisition of the multi-cancer early detection test maker. In addition to stiff opposition from activist investor Carl Icahn that cost Illumina’s previous CEO and board chair their positions, European and U.S. regulators have consistently opposed the deal.
Respiratory imaging technology company 4Dmedical Ltd. is acquiring Imbio LLC for $45 million to create a comprehensive portfolio of cardiothoracic imaging technologies. The news comes on the heels of U.S. FDA clearance of 4Dmedical’s computed tomography lung ventilation analysis software in November 2023.
With an urgent need to create new technologies to improve the detection of traumatic brain injuries (TBI), researchers from the University of Birmingham, U.K., have designed and developed a diagnostic device that can detect TBI by shining a laser into the eye.
Backbeat Medical Inc. is seeking patent protection for methods and systems for controlling blood pressure to either treat hypertension by using a first electrical stimulation pattern that reduces both systolic blood pressure and diastolic blood pressure.
Angle plc’s Parsortix system, which captures and harvest circulating tumor cells (CTCs) for liquid biopsy analysis, has been used in breakthrough work by researchers at the University of New Mexico looking into the role of CTC gene expression in the progression of melanoma brain metastasis. The researchers used the Parsortix system to harvest CTCs for analysis and concluded that “… gene expression in CTCs could be pivotal to prescribing more targeted treatment based on the needs of the patient.”
The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.
Omini SA hopes that the multiplexed blood testing platform it is developing will transform the lives of patients suffering from heart failure. With its multiplex, sensor-based testing strip that simultaneously measures four key biomarkers from a single drop of blood, the company’s technology should increase the chance of a patient’s survival and reduce pressure on health care systems, Joanne Kanaan, CEO and co-founder of Omini, told BioWorld.
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.
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