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BioWorld - Monday, July 13, 2026
Home » Topics » Medical technology, Regulatory

Medical technology, Regulatory
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COVID-19 vaccine vials behind U.S. capitol building
Pfizer, Moderna agree to deliver 200M more doses

House committee inks spending package for COVID-19 pandemic

Feb. 12, 2021
By Mark McCarty
The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.
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Mask with Brazilian flag

Seegene strengthens footprint in Latin America via COVID testing

Feb. 12, 2021
By Gina Lee and Sergio Held
COLOMBIA – South Korea’s molecular diagnostics firm Seegene Inc. is expanding operations in the Brazilian market after Anvisa, the country's health care surveillance agency, cleared its multi-assay product through a COVID-19 emergency pathway. Seegene manufactures Allplex, a SARS-CoV-2/FluA/FluB/RSV test able to screen and differentiate eight targets.
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Device image

Braincool wins breakthrough nod for system to prevent painful chemo side effect

Feb. 12, 2021
By Meg Bryant
Braincool AB has scored a breakthrough device designation from the U.S. FDA for its Cooral system, a medical cooling technology for therapeutic hypothermia and oncology. The status acknowledges Cooral’s potential to prevent oral mucositis (OM), a complication of chemotherapy.
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Regulatory front for Feb. 12, 2021

Feb. 12, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA cites pivotal study failure for Lutonix 014; HHS adds to PREP Act immunity; Dermal fillers on tap at FDA advisory; GAO urges a pause in VA EHR deployment.
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Regulatory actions for Feb. 12, 2021

Feb. 12, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson.
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Calculator and pills

TGA seeks feedback on impact of proposed fee changes for drugs and devices

Feb. 12, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.
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Device image

Cerus Endovascular wins breakthrough status for brain aneurysm treatment

Feb. 11, 2021
By Meg Bryant
The U.S. FDA has granted breakthrough device designation to Cerus Endovascular Ltd. for its Contour neurovascular system for the treatment of intracranial aneurysms. The company is targeting the second or third quarter of this year for the start of its IDE clinical trial.
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Global pandemic threat
Keeping up with the variants

Governments challenged with sequencing, tracking SARS-CoV-2 variants

Feb. 11, 2021
By Mark McCarty
Governments across the globe are struggling to keep pace with the SARS-CoV-2 virus’s impact on public health, but the new variants are presenting their own challenges. The next task facing governments across the globe is to sequence the latest mutated variants of the virus and keep track of any further mutations, all while validating new and revamped existing tests, a task that is likely to prove difficult to meet for at least the next few months.
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Regulatory front for Feb. 11, 2021

Feb. 11, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA announces new health care supplier standard; Laggardly patient record response costs provider $75k; New med-tech resource platform now includes logistics; Spectrascience the subject of speculation, SEC action; HC nudging along with regulatory modernization plan.
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Regulatory actions for Feb. 11, 2021

Feb. 11, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Access Vascular, Braincool, Brainq, Cerus Endovascular, Genscript, Limacorporate, Roche, Techmah Medical.
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