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BioWorld - Thursday, May 14, 2026
Home » Topics » Medical technology

Medical technology
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Regulatory actions for Aug. 4, 2021

Aug. 4, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Immunovia.
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Other news to note for Aug. 4, 2021

Aug. 4, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Avacta Group, Electrocore, Fio, Mel-Mont Medical, Mighty Oak Medical, Neuropace, Orthopediatrics, Relay Medical, Speedx.
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In the clinic for Aug. 4, 2021

Aug. 4, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Boston Scientific, Daxor, Fist Assist, Natera.
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Financings for Aug. 4, 2021

Aug. 4, 2021
Med-tech firms raising money in public or private financings, including: Append Medical, Livanova.
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Appointments and advancements for Aug. 4, 2021

Aug. 4, 2021
New hires and promotions in the med-tech industry, including: Cerus, Foundation Medicine, Heartflow, HST Pathways, Intelgenx Technologies, Personal Genome Diagnostics, Rapid Micro Biosystems.
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FDA icons

Keystone fails to wow FDA committee in hearing for Triguard 3

Aug. 3, 2021
By Mark McCarty
Keystone Heart Ltd. had the unusual experience of being the sponsor of a rare class II device appearance before an FDA advisory committee, which considered whether the company’s Triguard 3 device was substantially equivalent (SE) to a predicate device. However, the company’s bid for an SE result was unsuccessful, likely leaving Keystone with a considerable additional regulatory lift before the company can get to market.
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U.S. Capitol building

U.S. lawmakers to HHS: Use the tools you have to lower prices

Aug. 3, 2021
By Mari Serebrov
Instead of waiting for Congress to come up with a solution to reduce drug prices, a trio of U.S. lawmakers told the U.S. Department of Health and Human Services (HHS) it needs to tackle drug prices with the tools it already has – compulsory licensing and march-in rights.
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Iterative Scopes group photo

Iterative Scopes raises $30M for AI-driven gastroenterology tools

Aug. 3, 2021
By Meg Bryant
Iterative Scopes Inc. picked up $30 million in series A financing to advance artificial intelligence (AI)-powered precision medicine for gastroenterology. The money will be used to further develop the company’s algorithms and to propel its growing life sciences businesses. Spun out of the Massachusetts Institute of Technology by founder and CEO Jonathan Ng, the company is developing AI-driven computational tools to identify appropriate treatments and guide clinical trials for patients suffering from gastrointestinal diseases.
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Brain and blood cells

Hong Kong researchers develop blood test for Alzheimer’s disease

Aug. 3, 2021
By Elise Mak
Researchers from The Hong Kong University of Science and Technology (HKUST) have developed a blood test to detect Alzheimer’s disease (AD) early. They said the test has an accuracy level of over 96% and can also monitor disease progression. This is a new approach to detecting AD compared to the commonly used cognitive tests and invasive methods that detect changes in the brain caused by AD.
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Amyloid plaque on nerve cell

In vivo gene editing alleviates amyloid pathologies

Aug. 3, 2021
By John Fox
Brain-wide genome editing via a single systemic dose of modified adeno-associated virus variants that cross the blood-brain barrier may represent a promising new approach for the development of disease-modifying treatments for familial Alzheimer's disease. This strategy could also be applicable to other central nervous system (CNS) disorders, according to a proof-of-concept (PoC) study led by researchers at The Hong Kong University of Science and Technology (HKUST).
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