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BioWorld - Wednesday, June 7, 2023
Home » Authors » Sergio Held

Sergio Held

Articles

ARTICLES

Multiple concerns remain beyond Europe’s borders with MDR regulation despite extension

March 1, 2023
By Zhang Mengying and Sergio Held
No Comments
Europe has given device makers more time to meet requirements set out in the 2017 Medical Devices Regulation (MDR). The European Parliament approved in mid-February an extension of the transition periods for medical device and IVD manufacturers to comply with the new rules, which aim to enhance safety for patients and ensure the “smooth functioning of the internal market.”
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Brazilian flag

Brazil’s new medical device rules starting in March promise to simplify process

Jan. 25, 2023
By Sergio Held
No Comments
Brazilian health care regulator Anvisa unveiled new medical device rules that promise to simplify over two decades of accumulated directives, putting into force changes announced by the health care surveillance agency in 2022.
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Brazilian flag
New regulation will come into force in March 2023

Brazil updates regulations for medical device registration

Oct. 5, 2022
By Sergio Held
No Comments
Anvisa, Brazil´s health care surveillance agency, issued new regulations for the registration of medical devices as it works to harmonize its own rules with international standards and integrate its medtech industry with those of other countries in the region.
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Cuban flag

Cuban drug for Parkinson’s and Alzheimer’s diseases moves to phase III

Sep. 13, 2022
By Sergio Held
No Comments
An investigational drug developed in Cuba for the potential treatment of Alzheimer´s and Parkinson's diseases has moved forward to phase III trials there, where scientists are optimistic about results of previous studies. The candidate, named Neuroepo and branded Neuralcim, was developed by the Center of Molecular Immunology (also known by its Spanish acronym CIM), a state-owned lab in the Caribbean nation.
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Brazilian flag

Companies race to conquer the Monkeypox IVD market in Brazil

Aug. 25, 2022
By Sergio Held
No Comments
Five companies have applied for marketing authorizations in Brazil to deliver rapid test kits to diagnose monkeypox cases in real time.
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Henlius establishing big biosimilar deals in Latin America

June 7, 2022
By Sergio Held
No Comments
Two major deals inked by Shanghai Henlius Biotech Inc. in May confirm the company’s plans to invest heavily in the Latin American market.
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Henlius establishing big biosimilar deals in Latin America

June 1, 2022
By Sergio Held
No Comments
Two major deals inked by Shanghai Henlius Biotech Inc. in May confirm the company’s plans to invest heavily in the Latin American market.
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Brazilian flag

Brazil readies to adopt SaMD regulation

May 27, 2022
By Sergio Held
No Comments
Brazil’s health care regulator plans to start enforcing in July new regulations for software as a medical device (SaMD), clearing up doubts about its oversight over intangible health care assets such as software.
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Map of Latin America, South America

Latin America’s med-tech sector faces steep hurdles

Dec. 31, 2021
By Sergio Held
No Comments
The med-tech industry across Latin America continues to grow, but the growth is uneven, concentrated in a handful of countries and faces significant challenges. A report released in December by the United Nations Economic Commission for Latin America and the Caribbean (ECLAC) reveals the complexity of the region's med-tech trade balance and underscores the main challenges for the industry in the region, whose performance was also impacted by the COVID-19 pandemic.
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Heart illustration

Stereotaxis plans to tackle the Chinese ablation market via deal with Microport

Sep. 9, 2021
By Sergio Held
No Comments
Robotic technologies company Stereotaxis Inc. is scaling up its footprint in the Chinese med-tech market, with a deal to commercialize its robotic technology for heart rhythm therapy in China with Shanghai Microport EP Medtech Co. Ltd. The St. Louis-based Stereotaxis aims to introduce a second-generation robot called Genesis to the Chinese market that uses a magnetic navigation technology to treat heart rhythm disorders. Its partner, Shanghai Microport EP Medtech, is a division of one of China's largest med-tech manufacturers, Shanghai-based Microport Scientific Corp.
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