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BioWorld - Sunday, April 5, 2026
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Medical technology
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Regulatory actions for August 22, 2025

Aug. 22, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Esaote.
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U.S. flag on columned building

Stopgaps help some survive, but over time, NIH funding is unique

Aug. 22, 2025
By Anette Breindl
No Comments
On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.
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Futuristic medicine research illustration with petri dishes and pipette
Infection

Generative AI comes up with novel antibiotic structures

Aug. 22, 2025
By Anette Breindl
No Comments
Researchers at the Massachusetts Institute of Technology have developed a generative AI model that was able to generate novel antibiotic structures from either chemical fragments or de novo, starting from ammonia, methane, water or no starting point at all. In a study that was published online in Cell, the team tested two dozen of more than 10 million structures that were proposed as potential antibiotics by the model.
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CMS logo and website

Stakeholders press CMS to act on breakthrough device coverage

Aug. 21, 2025
By Mark McCarty
A group of stakeholders including medical device makers have penned a letter to Centers for Medicare & Medicaid Services administrator Mehmet Oz to urge the agency to cover breakthrough medical devices, an attempt to resurrect administrative action on a question that legislators failed to address in 2024.
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Money sack with British pound symbol

Neurovalens raises £6M for neurostimulation devices

Aug. 21, 2025
By Shani Alexander
Neurovalens Ltd raised £6 million (US$8 million) in an investment round for its non-invasive neurostimulation devices, which treat insomnia and manage anxiety. The company will use the funds to expand its presence in the U.S. and accelerate sales of its U.S. FDA-cleared devices, Modius Sleep and Modius Calm. The round was led by the Investment Fund for Northern Ireland (IFNI) with support from new and existing investors.
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Signots Stelo

Signos adds AI to CGM to drive weight loss

Aug. 21, 2025
By Annette Boyle
Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.
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Novocure's Optune Lua

Novocure files PMA for use of Optune in pancreatic cancer treatment

Aug. 21, 2025
By Holland Johnson
Novocure GmbH said it submitted a premarket approval application to the U.S. FDA for its Optune Lua wearable device tumor treating fields therapy for the treatment of locally advanced pancreatic cancer.
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Appointments and advancements for August 21, 2025

Aug. 21, 2025
New hires and promotions in the med-tech industry, including: Biobeat Technologies, Medx Health, Sonendo, Trinity Biotech.
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Financings for August 21, 2025

Aug. 21, 2025
Med-tech firms raising money in public or private financings, including: Brainsway, Neurolief.
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Regulatory actions for August 21, 2025

Aug. 21, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainsway, Neurolief.
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