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Mark Quinlan, UPS
November 12, 2015
Mark Quinlan, UPS

Embrace Regulations, Improve Patients’ Lives

A Q&A on how device companies can respond to supply chain risks and regulations.

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Columns

June 22, 2026

CMS Proposes TAVR Medicare Coverage is Potential Boost for Edwards Lifesciences

By MedTech Intelligence Staff

CMS’s proposed expansion of Medicare TAVR coverage to include select asymptomatic severe aortic stenosis patients and reduce access barriers for symptomatic patients could significantly increase TAVR adoption, creating a growth opportunity for Edwards Lifesciences through expanded eligibility, higher procedure volumes, and continued leadership in structural heart care.

June 1, 2026

If Your AI Can’t Explain Itself, Can FDA Authorize It?

By Lavanya Ramnath, Srividya Narayanan

Why is algorithmic transparency becoming an increasingly important consideration in FDA's review of AI/ML medical devices?

May 11, 2026

FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

By MedTech Intelligence Staff
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FDA Commissioner Marty Makary says, one-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness.

May 11, 2026

FDA Expands AI Capabilities: Launches ELSA and Completes HALO Data Platform Consolidation

By MedTech Intelligence Staff
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The agency launched Elsa 4.0, an upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.  

May 11, 2026

Trump Planning to Fire FDA Commissioner Marty Makary

By MedTech Intelligence Staff

Top administration officials have become increasingly convinced Makary has to go because, in addition to months of turmoil, complaints from some in the pharmaceutical industry have continued to mount, people familiar with the matter said.

April 24, 2026

CMS, FDA Announce RAPID Coverage Pathway to Accelerate Device Reimbursement

By MedTech Intelligence Staff

New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.

April 6, 2026

Allevion Medical Receives 510K Clearance for Vantage Spinal Decompression System

By MedTech Intelligence Staff

Allevion Medical Receives FDA Clearance for Vantage™, Introducing a Fully Disposable Approach to Minimally Invasive Spinal Decompression.

April 3, 2026

Boston Scientific receives FDA clearance for the Asurys Fluid Management System

By MedTech Intelligence Staff
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New technology designed to provide a single irrigation management system for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures.

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