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AI in the EHR
March 27, 2026
AI in the EHR

Artificial Intelligence: ROI, not Clinical Autonomy, Leads Operational Workflows

By MedTech Intelligence Staff

What we’re reading on LinkedIn… Review of leading healthcare AI reports illustrate several conditions creating fertile ground for applied AI in healthcare operations.

Medtronic
March 27, 2026
Medtronic

Medtronic and Merit Medical Systems distribution agreement for new, ViaVerte basivertebral nerve ablation system

By MedTech Intelligence Staff

Exclusive agreement expands Medtronic’s comprehensive pain interventions portfolio, increases treatment options for patients living with chronic pain.

Continue reading →

March 27, 2026

Breakthrough Device Designation for Noah Labs Vox Heart Failure Detection Device

By MedTech Intelligence Staff

Noah Labs Vox,™ a voice-based algorithm that detects worsening heart failure weeks before hospitalization, has received US Food and Drug Administration (FDA) Breakthrough Device Designation (BDD).

Continue reading →

Cairn Surgical
March 23, 2026
Cairn Surgical

Breast Cancer Locator System Submitted for De Novo 510(k) by Cairn Surgical

By MedTech Intelligence Staff

FDA clearance of the BCL System will give surgeons access to precise information about each breast tumor that has never before been available to them, according to the company.

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ApiFix, Adolescent idiopathic scoliosis
March 23, 2026
ApiFix, Adolescent idiopathic scoliosis

17 spine surgery firsts in Q1

Several surgeons debuted spine devices and other techniques during the first quarter from cervical discs to personalized implants.

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March 20, 2026

Mindray North America Enters Ventilator Market

By MedTech Intelligence Staff

Mindray says its entry into the ventilator market marks a significant step in expanding advanced respiratory care options for clinicians and patients, reinforcing the medical device leader’s commitment to driving innovation in healthcare.

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March 20, 2026

LivaNova Receives FDA Premarket Approval for to treat Moderate to Severe Obstructive Sleep Apnea

By MedTech Intelligence Staff

Hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language. The next-generation, MRI-compatible device is expected to launch in the first half of 2027, pending FDA supplement review.

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March 20, 2026

Perfuze Receives FDA 510(k) Clearance for Millipede88 Aspiration Catheter

By MedTech Intelligence Staff

Perfuze states the Millipede88 is the first 088 aspiration catheter with patented corrugated technology cleared for standalone direct aspiration — no large-bore intermediary required — backed by independently adjudicated MARRS study data showing a 77% first-pass effect1 in M1 occlusions and 96% delivery success.

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EPA Logo
March 20, 2026
EPA Logo

EPA proposes new rule on Ethylene Oxide Emissions: Could Loosen Limits on Medical Device Sterilization

By MedTech Intelligence Staff

The medical device industry and EPA have been in ongoing debate over balancing the need for sterile medical equipment with concerns about pollution near sterilization plants.

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Prodeon Medical
March 18, 2026
Prodeon Medical

Prodeon Medical FDA 510(k) approved for the Urocross Expander System, a Non-Permanent Retrievable Implant for Treating Benign Prostatic Hyperplasia

The Urocross Expander System is designed to remodel the obstructing prostatic lobes during the six-month indwell time and is intentionally retrieved, leaving no permanent foreign material behind.

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Columns

August 10, 2026

What 524B and QMSR Change About Medical Device Risk

Balancing Cyber Risk

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, recall, and management liability. Where device makers are commonly unprepared against the new baseline, including the gap between cyber risk and product liability for software and devices.

August 10, 2026

Why Few MedTech Sales Teams Are Using AI Where It Matters Most

By Lee Smith

A MedTech survey revealed that most sales teams are not using AI for strategic purposes, such as identifying opportunities, prioritizing accounts, or research. Instead, AI is mostly deployed to complete administrative tasks, such as drafting emails and summarizing meetings. Why is more needed?

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 8, 2026

Medtronic Advances Hugo Robotic Surgery Platform with Key FDA Filings and Product Approvals

By MedTech Intelligence Staff
Medtronic Logo

Medtronic announced several regulatory milestones for its Hugo robotic-assisted surgery platform, including FDA submissions for general and gynecologic surgery indications and the LigaSure™ RAS instrument, alongside FDA clearance for its ProGrip™ Advanced hernia mesh. The developments expand the company's robotic surgery portfolio and support its growth strategy in minimally invasive surgical care.

June 8, 2026

Medtronic Posts Strongest Revenue Growth in a Decade, Driven by Cardiovascular and Surgical Businesses

By MedTech Intelligence Staff
Medtronic Logo

Medtronic reported robust fiscal 2026 results, fueled by strong growth in cardiovascular, medical surgical, and diabetes technologies, while advancing key product launches, regulatory milestones, and strategic acquisitions.

June 8, 2026

Boston Scientific Plans Indiana Distribution Center, 300 New Jobs

Boston Scientific

Boston Scientific will invest $138 million to build a 500,000-square-foot global medical device distribution facility in Plainfield, Indiana, creating up to 300 high-wage jobs and expanding the state's growing life sciences sector.

May 20, 2026

Fixing Eligibility at the Point of Care: The Missing Link in Medical Device Reimbursement Integrity

By Peter Justen

MTI Viewpoints Insights shared by industry relative to healthcare and the advancement of medical technology. Peter Justen is Founder and CEO of AmeriTrust Solutions. He works at the intersection of technology, data, and human-centered design to improve access to government...

May 20, 2026

The failure of the ‘usual suspects’ approach to life science recruitment

By Ivor Campbell

How has AI impacted the way in which companies recruit for senior specialists, particularly in highly niche roles in MedTech, biotech and pharmaceutical development? Finding the right people for these roles has never been harder.

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  • MedTech Economics
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