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

MedTech Global Insights

What"s next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you"re an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.

science life sciences

All Episodes

01:56

US/EU AI MedTech Split: Pure Global on Hidden Hurdles

MedTech Global Insights ·

2026/01/14

The promise of AI in medical devices is immense, but new guidance from US and European authorities reveals a widening gap in regulatory expectations. This episode of MedTech Global Insights breaks down the critical differences in how the FDA and EU handle AI device updates and what this means for your global strategy.We explore the practical impact of the FDA's flexible framework versus the EU's more rigid requirements under the MDR and AI Act. For innovators, this divergence creates major

en

02:13

U.S. MedTech SBOM Crisis: Pure Global's Post-Market...

MedTech Global Insights ·

2026/01/13

In the first week of January 2026, the FDA activated a new, mandatory cybersecurity rule, fundamentally changing the requirements for U.S. market access. This episode of MedTech Global Insights unpacks the immediate impact of this regulation, focusing on the challenging new requirement for a Software Bill of Materials (SBOM) and robust post-market surveillance plans. We explore what this means for manufacturers globally and how it complicates existing strategies for markets like the European

en

01:54

Pure Global: USA's Wearable Tech Greenlight & The...

MedTech Global Insights ·

2026/01/12

In this episode, we dissect the U.S. FDA's landmark decision from the first week of January 2026 to ease regulations on general wellness and digital health wearables. This policy shift is set to accelerate innovation in the consumer health tech market but introduces a razor-thin line between being an unregulated gadget and a regulated medical device. We explore how a single marketing claim can completely change a product's path to market. Imagine a startup with a new smart ring designed to track

en

02:09

Pure Global: US MedTech & The Real Reason for FDA's...

MedTech Global Insights ·

2026/01/11

This week, we dissect a critical trend impacting the US MedTech landscape: the sustained surge in FDA warning letters. This isn't a random enforcement spike; it's a targeted campaign against systemic weaknesses in Quality Management Systems that many companies mistakenly believe are compliant. We move beyond the headlines to reveal the specific failures in CAPA and complaint handling that are putting market access at risk.We explore why the FDA is digging deeper than ever before, scrutinizing not

en

01:47

Pure Global: The US FDA's Hidden AI MedTech...

MedTech Global Insights ·

2026/01/10

This week, we dissect a critical, under-the-radar policy shift from the US FDA concerning AI and machine learning medical devices. Regulators are cracking down on Predetermined Change Control Plans (PCCPs), demanding a level of detail that many companies are unprepared for. This change fundamentally alters the roadmap for getting self-improving algorithms to market. We explore the new requirements, the strategic implications, and what this means for the future of adaptive medical technology

en

01:54

USA MedTech AI: Pure Global on the FDA's Hidden PCCP...

MedTech Global Insights ·

2026/01/09

This week, MedTech Global Insights dives into the US FDA's groundbreaking new final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled medical devices. This policy promises to accelerate innovation by allowing pre-approval for future algorithm updates, but it also introduces significant strategic complexities that could trap unprepared companies.We explore what this means for the future of adaptive medical technology. Consider an AI diagnostic software company. Their biggest

en

01:56

USA AI Oncology: Beyond FDA De Novo - Pure Global...

MedTech Global Insights ·

2026/01/08

In this episode, we dissect the recent FDA De Novo approval of a revolutionary AI diagnostic tool for oncology. While the industry celebrates this milestone, we look beyond the headlines to uncover the complex and demanding post-market challenges that await, from stringent real-world data collection to cybersecurity vigilance.Imagine a startup that poured all its resources into achieving this landmark FDA approval. They are now facing immense pressure to commercialize, but are suddenly confronted

en

01:57

USA's LDT Shift: Pure Global on the IVD Compliance...

MedTech Global Insights ·

2026/01/07

This week, MedTech Global Insights dives into the FDA's game-changing final rule to regulate Laboratory Developed Tests (LDTs) as medical devices. We unpack the agency's rationale behind this historic policy shift, ending decades of enforcement discretion that allowed thousands of labs to develop tests without direct FDA oversight. This episode explores the profound impact on innovation, patient safety, and the competitive landscape of the diagnostics industry.We break down what this means for

en

02:16

USA's AI SaMD Gatekeepers: Pure Global on the FDA's...

MedTech Global Insights ·

2026/01/06

The FDA just dropped a bombshell on the AI medical device world. On January 2nd, they unveiled the 'AI-Driven SaMD Pre-Certification Excellence Program,' or AIPEP. This new pilot program promises a fast track for AI-powered software, but it comes with a catch: a mountain of new requirements for data transparency and algorithm validation. This move could reshape the competitive landscape, creating a new class of winners and losers in the digital health space. Imagine you're a mid-sized MedTech firm

en

01:57

U.S. MedTech: Pure Global on FDA's New Real-World...

MedTech Global Insights ·

2026/01/05

In the final days of 2025, the U.S. FDA unveiled a pivotal shift in policy, now allowing broader use of Real-World Data (RWD) in medical device submissions. This episode of MedTech Global Insights unpacks what this means for the industry, from startups to global enterprises. We explore the immense opportunities this presents for accelerating innovation and improving post-market surveillance.This change moves beyond theory and presents a new, tangible pathway for market access. We discuss the

en

01:48

USA Connected Devices: The FDA's Cyber Wall | Pure...

MedTech Global Insights ·

2026/01/04

In the final days of 2025, the medical device world felt the full force of the U.S. FDA's new cybersecurity mandate. With the 'Refuse to Accept' policy now in effect, the agency is turning away submissions that fail to meet stringent new security requirements before they are even reviewed. This is not a minor checklist item; it's a fundamental shift in how devices are designed, developed, and maintained. For manufacturers globally, failing to provide a comprehensive cybersecurity plan is now the

en

01:56

EU's AI MedTech Ambush: Pure Global on the New RWE...

MedTech Global Insights ·

2026/01/03

In the final days of 2025, EU regulators issued a surprise mandate that reshapes the landscape for AI-driven medical devices. A new guidance requires the use of Real-World Evidence (RWE) for continuous, post-market validation of AI/ML algorithms, impacting all companies planning to enter or remain in the European market. This episode of MedTech Global Insights breaks down what this means for your 2026 submission strategy and beyond. We explore the shift from a one-time approval to a dynamic

en

02:06

USA's RWD Shift: Pure Global on The New Evidence...

MedTech Global Insights ·

2026/01/02

In the final days of 2025, the US FDA made a pivotal change to how it evaluates medical devices, opening the door for Real-World Data (RWD) to take center stage in regulatory submissions. This episode breaks down what this policy shift means for the MedTech industry, moving beyond the traditional reliance on expensive clinical trials. We explore the immense opportunities this creates for faster, more cost-effective market access, especially for devices already approved outside the United States. We

en

01:57

São Paulo's SaMD Gambit: Pure Global's Insider Guide

MedTech Global Insights ·

2025/12/22

Brazil has just opened a regulatory fast-track for AI medical devices, promising market approval in just 90 days. This is a massive opportunity for MedTech companies looking to expand into Latin America, but a hidden challenge is causing significant delays and unexpected costs for even the most prepared firms.This episode of MedTech Global Insights unpacks ANVISA's new resolution. We reveal the stringent, often overlooked post-market surveillance and data privacy rules that are tied to this

en

02:16

Pure Global: Brazil's AI MedTech Rush & Its Hidden...

MedTech Global Insights ·

2025/12/21

Brazil's health authority, ANVISA, recently announced an exciting fast-track approval pathway for AI and machine learning medical software. This move promises to accelerate market access in one of Latin America's biggest markets, creating a massive opportunity for MedTech innovators worldwide.However, this golden opportunity comes with hidden complexities. The initial announcement lacks detailed guidance, creating a confusing landscape for companies eager to submit. Without a clear understanding

en

01:56

Pure Global: Brussels' IVDR Delay, Escaping the...

MedTech Global Insights ·

2025/12/20

Last week, the European Commission extended the challenging IVDR transition deadlines, giving diagnostic manufacturers more time. While this seems like a reprieve, it introduces significant strategic complexity and the dangerous risk of complacency. We dissect the new tiered deadlines and analyze what this major regulatory shift truly means for the global IVD market. This episode moves beyond the headlines to explore the tough questions company leaders now face. Do you delay your investment in IVDR

en

01:50

Europe's EUDAMED Deadline: The Final Countdown | A...

MedTech Global Insights ·

2025/12/19

The European Commission has ended years of uncertainty by announcing a mandatory deadline for EUDAMED. As of May 28, 2026, medical device and IVD companies must comply with the database's core modules. This isn't just a new database; it's a new era of regulatory transparency that demands immediate and strategic action from everyone in the MedTech industry.This episode breaks down what the mandatory deadline for Actor, UDI/Device, and Certificate registration truly means. We explore the massive

en

01:43

UK MedTech: Pure Global on GSK's Post-Brexit...

MedTech Global Insights ·

2025/12/18

This week, we unpack the major implications of the UK MHRA's landmark approval of GSK's new twice-yearly asthma treatment. This is more than a product launch; it's a crucial signal for the global MedTech industry on how to successfully navigate the complex and independent post-Brexit regulatory landscape. We explore why the UK is re-emerging as a viable, first-launch market for innovative devices.We analyze the specific regulatory hurdles that trip up many companies, from UKCA marking to divergent

en

02:16

Boston's AI Challenge: FDA's New Rules | A Pure...

MedTech Global Insights ·

2025/12/17

Last week, the FDA unveiled a game-changing fast-track for AI diagnostics, but a hidden challenge is already causing chaos for unprepared companies. We break down the new 'Agile PMS' framework and what it means for your market access strategy.This new rule isn't just theory. We explore the real-world case of CardiaAI, a leading Boston-based startup that had its breakthrough product put on hold. Their story reveals the critical resource and data management gaps that this new regulation exposes,

en

02:11

Pure Global: USA MedTech's Risky QMS Shift Beyond ISO...

MedTech Global Insights ·

2025/12/16

The US FDA is making its biggest change to quality system regulations in a generation, harmonizing with the global ISO 13485 standard. This shift, mandated by the new Quality Management System Regulation (QMSR), presents both opportunities for streamlined global compliance and significant hidden risks for unprepared manufacturers.Many global companies with existing ISO 13485 certification are operating under the dangerous assumption that they are already compliant. We explore a real-world case

en

139 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