x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

PODCAST

LATAM MedTech Insights

Welcome to LATAM MedTech Insights, your essential guide to the booming medical technology and digital health sector across Latin America. Each episode, we dissect the key trends, investment opportunities, and regulatory news shaping the industry. Join us for in-depth interviews with the innovators, investors, and policymakers driving the future of healthcare from Mexico to Brazil.

science life sciences

All Episodes

01:49

Brazil's New MedTech Rules: Pure Global on Cracking...

LATAM MedTech Insights ·

2026/03/08

Brazil's MedTech market just experienced a seismic shift. ANVISA, the national regulatory agency, has rolled out its new comprehensive framework, RDC 751, fundamentally changing the rules for medical device registration and market access. This move aligns Brazil closer than ever with international standards like the EU MDR. In this episode, we break down what this massive overhaul means for manufacturers. We dissect the new risk classification system, the updated submission pathways, and the

en

02:14

Pure Global: Brazil's AI MedTech Gold Rush -...

LATAM MedTech Insights ·

2026/03/07

This week, we dissect the groundbreaking new resolution from Brazil's ANVISA, RDC 989, which establishes a new fast-track approval pathway for AI-driven diagnostic software. This is a pivotal moment for the MedTech industry in Latin America, promising to accelerate innovation and market access.However, this opportunity comes with significant new hurdles. The regulation introduces complex requirements for predetermined change control plans, mandates the use of local Brazilian patient data for

en

01:47

Pure Global: Brazil's UDI Shockwave, ANVISA's Hidden...

LATAM MedTech Insights ·

2026/03/06

Brazil's national regulatory agency, ANVISA, has unexpectedly accelerated the compliance deadlines for its Unique Device Identification (UDI) system, creating a significant new challenge for MedTech manufacturers. This sudden shift requires immediate action on labeling, data management, and submission strategies to avoid market disruption.While this presents a major hurdle, it also offers a competitive advantage to agile companies that can quickly adapt. This episode of LATAM MedTech Insights

en

01:43

Pure Global | Brazil's ANVISA Shock: Navigating the...

LATAM MedTech Insights ·

2026/03/05

This week, we dissect a sudden and significant regulatory enforcement shift from Brazil's ANVISA. The agency has accelerated the implementation of its comprehensive UDI traceability system for high-risk medical devices, a key part of its 2026-2027 agenda to harmonize with global standards. This move is catching many international manufacturers off guard, creating immediate challenges for market access and post-market compliance.We explore the concrete implications of this accelerated timeline,

en

01:53

Pure Global: Brazil's AI MedTech Approval - Hacking...

LATAM MedTech Insights ·

2026/03/04

Brazil's regulatory agency, ANVISA, is launching a major digital overhaul for 2026, promising to slash approval times and streamline market access for medical devices. This episode dives into the core of ANVISA's new agenda, from the 'AnvisAI' project aimed at modernizing submissions to new fast-track queues for lower-risk devices.We explore how this digital transformation is creating unprecedented opportunities for MedTech innovators. For instance, a company with a cutting-edge AI diagnostic tool

en

01:59

Pure Global: Brazil's AI MedTech Gambit - Navigating...

LATAM MedTech Insights ·

2026/03/03

This week on LATAM MedTech Insights, we dissect the groundbreaking news from Brazil's ANVISA. A new fast-track approval pathway for AI-powered medical software has just been announced, promising to revolutionize market access in Latin America's largest market. This is the opportunity the industry has been waiting for, but it comes with a complex twist. This newfound speed is coupled with a formidable set of new cybersecurity and data privacy mandates, tailor-made for Brazil. We explore the hidden

en

01:53

Brazil's ANVISA Digital Chaos: Pure Global on...

LATAM MedTech Insights ·

2026/03/01

In a move that sent shockwaves through the MedTech industry, Brazil's regulatory agency, ANVISA, launched a mandatory new digital submission platform for high-risk medical devices last week. This sudden shift away from traditional paper-based systems has left many manufacturers scrambling to adapt.This episode of LATAM MedTech Insights unpacks the immediate fallout of this decision. We explore the technical hurdles, the hidden documentation requirements, and the strategic implications for

en

01:50

Pure Global: Brazil's AI MedTech Brief—Decoding...

LATAM MedTech Insights ·

2026/02/28

This week, we dive into a critical regulatory update from Brazil's ANVISA that is reshaping the landscape for digital health and Software as a Medical Device (SaMD). The new guidance introduces stringent requirements for AI technologies, cybersecurity, and local data management, catching many international MedTech companies off guard. We explore why existing FDA or CE Mark documentation is no longer enough for the Brazilian market. This episode breaks down the new rules and discusses how adapting

en

01:51

Pure Global: Brazil & Mexico's MedTech Manufacturing...

LATAM MedTech Insights ·

2026/02/27

This week on LATAM MedTech Insights, we explore the significant shift in Latin America's medical device industry. The region is rapidly moving from being a net importer to a powerful hub for local MedTech manufacturing. We unpack the key drivers behind this acceleration, including supply chain strategy, cost benefits, and new government incentives in major markets like Brazil and Mexico.We dive into the real-world challenges and opportunities this trend presents. We analyze the complex

en

01:41

Pure Global: Cracking Brazil's New MedTech...

LATAM MedTech Insights ·

2026/02/26

Brazil's health agency, ANVISA, has just introduced a stringent new cybersecurity regulation for all connected medical devices. This sudden move, aimed at enhancing patient safety and data protection, presents immediate and complex challenges for manufacturers. It escalates compliance costs and extends timelines, demanding a new level of technical documentation that many were not prepared for. This podcast episode breaks down what the new rules demand and explores the strategic implications for

en

02:00

Pure Global: Brazil's MedTech Fast-Track - The Hidden...

LATAM MedTech Insights ·

2026/02/25

This week, we dissect a groundbreaking regulatory shift in Latin America's largest market. Brazil's ANVISA has just unveiled a new, accelerated pathway for high-risk medical devices by recognizing approvals from major global agencies, signaling a major push to attract cutting-edge technology.But this speed comes with a hidden cost. The new framework also introduces some of the strictest post-market surveillance demands seen in the region. We explore the critical balance between rapid innovation

en

01:49

Pure Global: Brazil's New Device Regs & The Risk...

LATAM MedTech Insights ·

2026/02/24

This week, we dive into a critical regulatory update from Brazil. ANVISA has just rolled out a new resolution that reshapes the essential safety and performance requirements for medical devices, placing a heavy new emphasis on lifecycle risk management and international harmonization. This change impacts everything from technical file preparation to post-market surveillance. We explore the specific new requirements for high-risk devices, software, and the increased demand for locally relevant

en

01:49

Pure Global: Brazil's AI MedTech Gambit—Navigating...

LATAM MedTech Insights ·

2026/02/23

This week, we dive into a landmark regulatory shift in Brazil. ANVISA has just launched a new, expedited approval pathway for AI-powered medical software, potentially slashing market entry timelines. This episode breaks down the immense opportunity this presents for MedTech innovators looking to enter Latin America's largest market. But there's a critical catch. This accelerated access comes with a new, aggressive post-market surveillance system that demands continuous real-world data reporting. We

en

01:44

Pure Global: Brazil's SaMD Shake-Up - Navigating...

LATAM MedTech Insights ·

2026/02/22

This week on LATAM MedTech Insights, we analyze the seismic new draft regulation from Brazil's ANVISA that is set to overhaul the rules for Software as a Medical Device (SaMD). This proposal introduces stringent new requirements for AI technologies and local data management, promising to reshape market access for all foreign MedTech companies targeting Brazil.We dive into the real-world impact by examining the case of a European AI diagnostics firm. Their expansion strategy, once clear, is now

en

02:05

Pure Global: Brazil's High-Risk Device Code Unlocked...

LATAM MedTech Insights ·

2026/02/21

Brazil's regulatory agency, ANVISA, has just rolled out game-changing new rules that create a fast-track pathway for high-risk medical devices. This episode breaks down the new "reliance" mechanism that allows manufacturers to use existing international approvals for quicker market access, and what the new clinical trial law means for MedTech innovation. We explore how these changes are dismantling long-standing barriers to entry in Latin America's largest market. For any company with an advanced

en

02:00

Brazil's AI Diagnostic Gold Rush: Pure Global on...

LATAM MedTech Insights ·

2026/02/20

In this episode, we dissect the groundbreaking news from Brazil's health agency, ANVISA. Last week, they launched "Agiliza IA Saúde," a new fast-track approval program for AI-powered medical software. This move could unlock massive opportunities in Latin America's largest market, promising to slash registration times for innovative diagnostic technologies.While the opportunity is immense, it comes with a critical challenge. The fast-track is gated by a strict compliance audit tied to Brazil's

en

01:58

Brazil's SaMD Cybersecurity: Pure Global on ANVISA's...

LATAM MedTech Insights ·

2026/02/19

This week, we dissect the groundbreaking new cybersecurity resolution from Brazil's ANVISA that is sending ripples through the MedTech world. The new rules for Software as a Medical Device (SaMD) go far beyond international standards, demanding a proactive, localized approach to cybersecurity and data validation that presents both challenges and opportunities.We explore how this regulation transforms the compliance burden, requiring continuous threat monitoring and incident reporting tailored

en

02:00

Brazil SaMD Shake-Up: Pure Global on ANVISA's Hidden...

LATAM MedTech Insights ·

2026/02/18

This week on LATAM MedTech Insights, we dissect the groundbreaking new Software as a Medical Device (SaMD) regulation just released by Brazil's ANVISA. This isn't just another update; it's a complete strategic reset for any digital health company targeting the Brazilian market. We explore the critical changes in risk classification for AI-driven software and the stringent new cybersecurity mandates that have just come into effect.Imagine a cutting-edge European AI diagnostics startup, poised to

en

02:04

Pure Global: Brazil's AI MedTech Gold Rush. ANVISA's...

LATAM MedTech Insights ·

2026/02/17

This week, we dissect the groundbreaking new resolution from Brazil's ANVISA that's set to revolutionize the AI-powered medical device landscape. We explore how this regulatory shift dramatically accelerates market access for Software as a Medical Device (SaMD) companies. Learn what this means for startups and established players eyeing the largest MedTech market in Latin America, and how the rules have fundamentally changed for innovators who were previously locked out by slow, hardware-focused

en

02:01

Brazil's RDC 751 Maze: Pure Global on MedTech...

LATAM MedTech Insights ·

2026/02/15

Brazil's medical device market has undergone its most significant regulatory overhaul in two decades with the full implementation of RDC 751/2022. This new framework replaces the long-standing RDC 185/2001, introducing a new risk classification system and technical documentation structure that aligns more closely with global standards like the EU MDR.While this harmonization presents long-term benefits, the immediate transition creates critical challenges for MedTech manufacturers. Companies must

en

129 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter