Medical Devices & Imaging News

Ultrahuman launches US-based wearable ring manufacturing facility

April 25, 2024 - For the first time in the United States, wearable smart rings will be manufactured in a domestic facility, marking further growth in the domestic wearable device market. According to the company’s press release, $35 million in investments will support the development of the UltraFactory in Indiana. The facility is expected to open within the...

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Deloitte report unveils $5–7 billion AI life sciences opportunity

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In a recent report by Deloitte, it has been estimated that the life sciences industry has the potential to unlock a staggering $5­–7 billion in value through the application of artificial...

FDA approves Eko Health’s Low EF detection AI for detecting heart failure

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Eko Health, recognized for its utilization of artificial intelligence (AI) in the early detection of heart and lung conditions, has revealed that its Low EF (ejection fraction) detection AI, integrated...

Former medical device CEO convicted for medical device fraud

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In a press announcement published on March 6, 2024, the United States Attorney’s Office of the Southern District of New York revealed that Laura Perryman, founder and former CEO of Stimwave, was...

FDA Approves Over-the-Counter Sale of Dexcom CGM

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On Tuesday, March 5, 2024, the United States FDA cleared the first over-the-counter continuous glucose monitor (CGM), the Dexcom Stelo Glucose Biosensor System. This new approval marks the first time...

FDA Updates Medical Device Sterility Guidelines

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Earlier this week, on January 8, 2024, the United States FDA announced a revised version of its guidance on medical device sterility: Submission and Review of Sterility Information in Premarket...

FDA Issues Draft Guidance for Using RWD in Medical Device Regulation

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On December 18, 2023, the United States Food and Drug Administration (FDA) published a draft guidance called “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical...

Minimizing the Impact of Bias in Healthcare Algorithms

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Last week, researchers published a special communications article in JAMA Network Open outlining principles to address and minimize the impacts of racial and ethnic bias in healthcare algorithms. The...

Ophthalmic Scans Provide Insight into Kidney Health

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Earlier this week, researchers at the University of Edinburgh published an article in Nature Communications revealing that choroidal and retinal thinning may be biomarkers for chronic kidney disease...

Ultrasound Technology May Provide a New Vaccine Delivery Method

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Earlier this week, at Acoustics 2023 Sydney, a doctoral researcher at the University of Oxford’s Institute of Biomedical Engineering, Darcy Dunn–Lawless, discussed his research on a...

AMA Publishes Guidance on AI Development, Deployment, Use

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Yesterday, November 28, 2023, the American Medical Association (AMA) announced its Principles for Augmented Intelligence Development, Deployment, and Use. The document provides a roadmap for the...

AstraZeneca Launches Evinova to Advance Digital Health Solutions

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AstraZeneca has unveiled Evinova, a pioneering health-tech business dedicated to accelerating innovation across the life sciences sector. Evinova — positioned as a separate entity within...

Johnson and Johnson Reveals General Surgery Robot Timeline

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Yesterday, Johnson and Johnson MedTech issued a press release to its investors and the public detailing the timeline for its general surgery robot. According to the announcement, the company intends to...

DeNovix CellDrop: The First ACT Label Certified Automated Cell Counter

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On October 17th, 2023, the DeNovix CellDrop Automated Cell Counter achieved a significant milestone by becoming the first automated cell counter in the United States to receive ACT Label certification...

FDA Launches Advisory Committee for Digital Health Technologies

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In a press release on October 11, 2023, the United States Food and Drug Administration announced that it created a new Digital Health Advisory Committee. According to the release, the committee will...

FDA Issues Update on the Philips BiPAP and CPAP Recalls

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Last week, the United States Food and Drug Administration released a statement updating consumers and industry leaders on the Philips Respironics recalls due to the potential risks associated with...

COVIDTests.gov Reopens for Americans to Request At-Home COVID Test

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Starting today, September 25, 2023, COVIDTests.gov will reopen for Americans to request free at-home COVID-19 tests. Each household will be eligible to receive four more free rapid antigen at-home...

Researchers Identify Depression Recovery Biomarkers Using DBS Device

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A recent study published in Nature with support from the National Institutes of Health (NIH) Brain Research Through Advancing Innovative Neurotechnologies Initiative, otherwise known as the BRAIN...

FDA Issues Three New Draft Guidance Documents for Medical Devices

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Last week, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued three new draft guidances to alter the 510(k) program. According to a statement...

Digital Assays Detect Nucleic Acids to Identify Clinical Pathogens

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On September 6, 2023, researchers from the Karolinska Institute published a study in Science Advances detailing a new pathogen detection assay that uses DNA nanoballs. The study was a collaborative...

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