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BioWorld - Friday, May 15, 2026
Home » Topics » Medical technology

Medical technology
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Regulatory actions for Aug. 30, 2021

Aug. 30, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Impedimed, Phase Scientific, Vapotherm, Visby Medical.
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Other news to note for Aug. 30, 2021

Aug. 30, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioventus, Cartiheal, Microport, Stereotaxis.
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In the clinic for Aug. 30, 2021

Aug. 30, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Xact Robotics.
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Financings for Aug. 30, 2021

Aug. 30, 2021
Med-tech firms raising money in public or private financings, including: Mimedx.
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Appointments and advancements for Aug. 30, 2021

Aug. 30, 2021
New hires and promotions in the med-tech industry, including: Micron Solutions, Renalytix.
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Diagram showing how Vivistim works

FDA greenlights first VNS-based stroke rehabilitation system

Aug. 27, 2021
By Annette Boyle
Vagus nerve stimulation (VNS) researchers notched another success with FDA approval of a drug-free rehabilitation system that uses the technology to help patients who have lost mobility in their hands and arms as a result of ischemic stroke regain function. Microtransponder Inc.’s Vivistim pairs rehabilitation exercises with VNS to enhance their impact. The clinical study evaluated by the FDA for the system's approval showed that Vivistim doubled the improvement in upper extremity motor function compared to supervised rehabilitative exercises alone at six weeks and 90 days.
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Man uses smartphone to take picture of BD Veritor At-Home COVID-19 test

FDA grants BD EUA for home COVID-19 smartphone test

Aug. 27, 2021
By Catherine Longworth
The FDA has issued an emergency use authorization (EUA) for Becton, Dickinson & Co.’s (BD) Veritor At-Home COVID-19 test – a rapid COVID-19 digital antigen test. The test, which is designed for home use, uses a mobile app from Los Angeles-based Scanwell Health Inc. that provides instructions on how to collect and transfer the nasal swab sample to the test stick. The smartphone camera is then used to capture, analyze and interpret results within 15 minutes. BD said it will initially be rolled out to businesses, schools and governments looking to provide a self-testing option.
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Pons headset, tongue stimulator image

Pons picks up pace with breakthrough device designation for treating gait and balance deficits

Aug. 27, 2021
By David Godkin
Helius Medical Technologies Inc. has received an FDA breakthrough device designation for its Portable Neuromodulation Stimulator (Pons) device for temporary treatment of dynamic gait and balance deficits due to stroke.
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Vocal soundwave illustration

Augnito looks to tap growing India market for speech recognition in health

Aug. 27, 2021
By T.V. Padma
The use of voice recognition systems based on artificial intelligence (AI) in health care is emerging in India, which offers a potentially enormous market, according to Scribetech Healthcare (India) Pvt. Ltd., one of the leading voice recognition companies in the country.
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Single strand RNA

New delivery system SENDs therapeutic RNA without triggering immune system

Aug. 27, 2021
By Anette Breindl
Investigators at MIT have identified a protein capable of delivering its own mRNA to cells, and engineered that protein to deliver mRNA sequences of their choosing. In a mouse model, the team used their approach to deliver the mRNA for two different proteins.
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