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BioWorld - Tuesday, April 14, 2026
Home » Topics » Diagnostics, Medical technology

Diagnostics, Medical technology
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Architectural pillars

Natera bests Neogenomics in district court patent litigation

Dec. 28, 2023
By Mark McCarty
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.
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U.S. Capitol building
‘23 in review

US FDA, Congress, fail to resolve lab-developed test mess

Dec. 27, 2023
By Mark McCarty

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.


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Apple Computer Inc. logo

Apple Watch ITC verdict paused by US appeals court

Dec. 27, 2023
By Holland Johnson
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.
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Ribbons of digital data
‘23 in review

Asia leads global efforts in precision health, AI-based models

Dec. 27, 2023
By Tamra Sami and Marian (YoonJee) Chu
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.
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Luma Vision VERAFEYE

Luma raises $22M for 4D cardiac imaging and navigation platform

Dec. 21, 2023
By Shani Alexander
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.
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heads together heatlth concussion mgmt
Patents

Heads Together Health’s concussion management platform details

Dec. 21, 2023
By Simon Kerton
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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Gavel with whistle

$14.7M pay-up time for Biotelemetry and Lifewatch

Dec. 19, 2023
By Annette Boyle
Biotelemetry Inc. and its subsidiary, Lifewatch Services Inc., agreed to pay $14.7 million to settle a whistleblower case alleging overbilling for remote cardiac monitoring. The qui tam case contended that the company’s online portal for its ACT-3L/MCT-3L device and its staff consistently and intentionally forced physicians’ staff to select or themselves selected the most expensive application for the device, despite intent and even written instructions to choose a less expensive service.
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Galleri instruction booklet on blood draw chair

Illumina concedes, plans to divest unholy Grail

Dec. 18, 2023
By Annette Boyle
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.
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4dmedical’s-Lung-Ventilation-Analysis-Software-(XV-LVAS)-reveals-detailed-maps-of-the-patterns-of-lung-motion-and-pulmonary-function2.jpg

4Dmedical acquires Imbio for up to $45M

Dec. 15, 2023
By Tamra Sami
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.
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Eyed TBI diagnostic

Hand-held Eyed device can rapidly diagnose TBI

Dec. 13, 2023
By Shani Alexander
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.
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