Six months out from the World Health Organization ending the global health emergency brought on by the pandemic, there’s no need for the World Trade Organization to expand a five-year intellectual property (IP) waiver for vaccines to COVID-19-related drugs, devices and diagnostics.
The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment.
Ubidx Inc. has designed a diagnostic system comprised of a fluidic single-use disposable and a base. While the fluidic single-use disposable or cartridge is generally described as being suitable for testing a single sample, the base or hub may be used numerous times to perform numerous tests using numerous fluidic single-use disposables or cartridges.
Researchers from the University of Minnesota are seeking patent protection and possible collaborators for their development of three-dimensional (3D) printed skin-wearable photodetector devices.
Natera Inc., said it has won a preliminary injunction against Neogenomics Inc., which halts any distribution of the latter’s RaDaR (Residual Disease and Recurrence) assay for detection of residual cancer DNA. The matter is anything but closed, and Neogenomics stated that it will appeal the decision, suggesting that this dispute will roll into and play out through much of 2024.
As calendar year 2023 limps to the finish line, a number of important regulatory developments emerged and then submerged, but one development that is also a non-development took center stage in the world of med tech. The U.S. FDA has proposed a regulation for lab-developed tests (LDTs), an issue that has been simmering for the better part of a decade thanks in no small part to Congress’ failure to pass legislation that would eliminate the FDA’s controversial approach to rulemaking.
In the latest salvo of the ongoing battle between Apple Inc. and Masimo Corp. over the use of a blood oxygen technology, a U.S. federal appeals court paused an International Trade Commission (ITC) ban on Apple’s watches. Apple reported on Dec. 19 that it would pull the Apple Watch Ultra 2 and Apple Watch Series 9 from its website on Dec. 21 and from its retail locations after Dec. 24, in response to an exclusion order issued by the ITC in October.
Asia continues its push to be the global leader with precision health and artificial intelligence/machine learning (AI/ML) models for diagnosing disease. Most health care systems in Asia’s major markets include universal health care coverage and are leaning toward electronic health records, paving the way for seamless use of data. At the same time, AI/ML is making its way across the entire health care spectrum, including applications to diagnose breast cancer, kidney disease, cognitive decline, depression and even retinal imaging to detect cardiac disease.
Luma Vision Ltd. raised $22 million in financing that will allow the company to secure U.S. FDA approval and prepare for commercialization of its 4D cardiac imaging technology platform, Verafeye. The series A3 financing round was led by existing investors EQT Lifesciences, ABV Uni Fund and imec.xpand. Luma also added three new investors comprising an undisclosed multinational strategic investor, Atlantic Bridge Growth Fund and Bayern Kapital.
Branelie Health Inc. seeks patent protection for a computer-implemented method and system for predicting appropriateness of treatment options for the management of traumatic brain injuries, particularly concussions.
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