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Insights & Industry News

Looking to for the latest insights and news in the healthcare industry? Our experts have you covered.
Check our articles on regulatory, clinical, and quality management for Biotech & MedTech.
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Insights

NEXT Oncology joins Proxima Clinical Research Early Phase Oncology Network to Advance Investigational Cancer Therapies
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Insights

CMS Proposes TCET Pathway for Faster Medicare Access to Medical Innovations
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Insights

Outsourcing vs. Self-Management: Clinical Trial Management in Med Device & Drug Development
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Insights

FDA Issues Final Guidance: Device Software Functions and Premarket Submissions
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Insights

2023 And Me | The Proxima Post
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Addressing Bias in AI for Medical Applications: A Comprehensive Guide
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Galen Data Webinar: Reducing AI Risk to Secure Regulatory Approval
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Insights

The Proxima Playbook: Who Wants to be a Wellness Device?
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Insights

Why, When and How to Implement a Quality Management System (QMS)
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A Patient-Centric Approach to Overcoming Patient Recruitment Challenges in Oncology
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5 Key Strategies for Clinical Trial Patient Recruitment
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Expert Tips For Writing Your Clinical Trial Protocol
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Insights

510(k) or PMA: Should Your Medical Device Receive FDA Clearance or FDA Approval?
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Biotech and MedTech Funding Series: Funding an Oncology Startup with CPRIT
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Navigating the Pre-Market Approval Application Process for Your Class III Medical Device
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Greenlight Guru Webinar: Clinical Considerations for Software and Artificial Intelligence (AI) / Machine Learning (ML)
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Insights

M1 MedTech Accelerator Program Announces First Cohort of Early-Stage Medical Device Companies
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Insights

How AI (Artificial Intelligence) Dentistry is Transforming the Dental Device Industry
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M1 MedTech Accelerator Program Opens Applications to Early-Stage Medical Device Companies
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Insights

The Top 3 Things You Need To Know About Cardiovascular Devices Under The FDA
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Insights

Greenlight Guru Webinar: Is Regulation Necessary for Quality?
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Insights

Demystifying De Novo
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Insights

All About About ASCA
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Insights

What's So Special About The Special 510(k) Program?
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Insights

Project MedTech: The Overlap of Regulatory Strategy And Business Strategy with Isabella Schmitt
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Insights

The Conception of Ideas | Inventing Tomorrow Podcast
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Insights

The 510(k) Program – All About This Submission Type
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Insights

Kevin Coker: Top Five Considerations When Selecting a Contract Research Organisation
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Insights

Isabella Schmitt: The Time is Now for Pediatric Device Development to be Centerstage
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Insights

Major Guidance Changes to Artificial Intelligence and Machine Learning
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Insights

Greenlight Guru Webinar: Company Essentials: The Benefits of a Well-Developed Regulatory Plan
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Insights

Demystifying The Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes with Greenlight Guru
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Insights

Top 3 Benefits of Breakthrough Device Designation or STeP Designation
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Insights

Global Medical Device Podcast: Comparing FDA's Breakthrough Devices Program & Safer Technologies Program
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Insights

Tackling ISO 10993-12 Biocompatibility
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Insights

Breakthrough Device Designation Reimbursement
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Insights

Design Controls Digest: 5 Phases of Design Controls You Need to Know
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Insights

Global Medical Device Podcast: Understanding and Handling Different Types of Feedback
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Insights

The Proxima Playbook: Understanding Your Biocompatibility Testing Requirements
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Insights

Global Medical Device Podcast: Why SaMD Companies Should be Leveraging Pre-Submissions to FDA
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Insights

Q2 Results Are In: Here are the Top Life Science Accelerators
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Insights

2020 MTI LIVE Webinar 5: Clinical Trials & Studies - Pre-Approval to Post-Market
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Insights

Global Medical Device Podcast: Addressing Clinical Trial Challenges & Concerns During Covid-19
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Insights

Global Medical Device Podcast: What You Need to Know About Clinical Evaluation & Validation for Software as a Medical Device (SaMD)
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Insights

Global Medical Device Podcast: How to Integrate Usability into your Medical Device
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Insights

"The Strategic Role of the Regulatory Professional", Regulatory Focus
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Insights

Global Medical Device Podcast: How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory
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Insights

Global Medical Device Podcast: 5 Tips for Hiring Medical Device Advisors
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Insights

FDA Rollouts Innovation and Improvements to Medical Device Sterilization
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Insights

Meet the Innovator: John Zellmer, MBA.
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Insights

Global Medical Device Podcast: Preparing for EU MDR
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Insights

Clinical Decision Support Software Guidance
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Insights

Safer Technologies Program (STeP) Breakdown
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Insights

Clinical Trials: Risky Business
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Insights

2019 MTI LIVE Webinar 5: Gathering Evidence: Clinical Trial Development & Design
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Insights

Why Your CRO Should Be With You From Concept to Commercialization
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Insights

Steps You Can Take to Answer If Your Product is A Drug or Medical Device
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Occasionally an opinion or fact.
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