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BioWorld - Wednesday, January 14, 2026
Home » Topics » Regulatory, BioWorld MedTech

Regulatory, BioWorld MedTech
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Inserting contact lens into eye

J&J wins Japan approval for first drug-releasing combination contact lenses for vision correction and allergic eye itch

March 29, 2021
By Gina Lee
HONG KONG – Johnson & Johnson Vision (J&J Vision) has received its first global approval from Japan for its Acuvue Theravision with Ketotifen contact lenses. The Japanese Ministry of Health, Labour and Welfare’s green light will help with patients with vision correction, while simultaneously alleviating ocular allergic symptoms for allergic conjunctivitis, while they wear the lenses.
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Regulatory actions for March 29, 2021

March 29, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helius Medical Technologies, Medtronic, Qiagen, STS Lab.
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Regulatory front for March 29, 2021

March 29, 2021
By Holland Johnson
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Canada invests in variant research; Time needed to develop immunity with Sputnik V.
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SARS-CoV-2 illustration turns from blue to red

FDA grants Twist Bioscience and Biotia EUA for capture-based NGS SARS-CoV-2 assay

March 26, 2021
By Annette Boyle
South San Francsico-based Twist Bioscience Corp. and Biotia Inc., of New York, received the first FDA emergency use authorization (EUA) for a capture-based next-generation sequencing (NGS) assay for the coronavirus that causes COVID-19. The technique reduces the likelihood of misdiagnosing or failing to identify mutations compared to standard sequencing.
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Canada pinned on globe

The school bell has already rung on recommendations for testing Canadian students for COVID-19, say critics

March 26, 2021
By David Godkin
TORONTO – A distinguished Canadian health care policy expert said a report from Canada’s COVID-19 Testing and Screening Expert Advisory Panel recommending testing and screening for school-age children and teachers comes “late in the game” now that the focus has shifted to vaccinating the Canadian population.
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Regulatory front for March 26, 2021

March 26, 2021
By Holland Johnson
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA approves Harmony device to treat patients with congenital heart disease.
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Regulatory actions for March 26, 2021

March 26, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curexo.
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FDA icons

FDA recommends vision check before applying dermal fillers

March 25, 2021
By Mark McCarty
The use of dermal fillers has spiked in recent years for a number of reasons, but so have the associated adverse events. An FDA advisory committee made several associated recommendations, including that a patient’s vision be prospectively evaluated prior to any peri-ocular treatment with fillers, but this could be a simple count-the-fingers check, something that should not appreciably increase procedure times or affect the volume of procedures.
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Fluxergy products

Fluxergy corrals CE mark for 1-hour COVID-19 test

March 25, 2021
By Meg Bryant
Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge. The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform.
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Regulatory front for March 25, 2021

March 25, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA seeks nominations for blood products advisory panel; Massachusetts hospital hit for HIPAA access non-compliance; No reports recorded for Medtronic recall; Tillis, Cotton eye patent examiner practice for Section 101 problem.
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