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.

A needle-free injection system for patients with diabetes developed by Nugen Medical Devices Inc. has been approved for use in 40 countries but until now has yet to crack the North American market. Nugen said it is now gearing up for FDA and Mexican approval of the Nugen MD needle-free injector following Health Canada’s approval of the system less than a month after the Toronto med tech went public in late 2021.

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.

The Royal Academy of Engineering in the U.K. has selected 15 entrepreneurs from seven different countries for the latest edition of its Leaders in Innovation Fellowships Advance (LIF Advance) program, including some that offer med-tech solutions.

With the Americas having the dubious distinction of the most COVID-19 cases in the world, the Pan American Health Organization (PAHO) is answering that “wake-up call” with plans to develop a collaborative platform to develop mRNA vaccine production in Latin America and the Caribbean.

Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote.

Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote.