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May 1, 2026

enVVeno Medical Receives FDA IDE Approval for Non-Surgical Replacement Venous Valve

By MedTech Intelligence Staff

The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.

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Medtronic
May 1, 2026
Medtronic

Medtronic Gains CE Mark for Stealth AXiS surgical system

Following recent FDA clearances, Medtronic is accelerating access to integrated planning, navigation, and robotics platform across Europe.

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Medtronic
May 1, 2026
Medtronic

Medtronic Continues Cardiovascular Care Growth with Completion of CathWorks Acquisition

By MedTech Intelligence Staff

CathWorks FFRangio System employs drug-free, wire-free technology for comprehensive physiological assessment.

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Stryker
April 20, 2026
Stryker

Styker Adds IVL Technology to Peripheral Vascular Portfolio with Amplitude Acquisition

By MedTech Intelligence Staff

Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral vascular portfolio

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BD, Becton Dickinson
April 10, 2026
BD, Becton Dickinson

BD Announced Application of CE Mark for the Liverty TIPS Stent Graft

By MedTech Intelligence Staff

Designed to expand treatment options for patients with cirrhosis and complications of portal hypertension, this next‑generation, adjustable‑diameter device represents the latest advancement by BD in interventional therapies addressing complex liver disease, according to the company.

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April 10, 2026

Blackstone and TPG Complete Acquisition of Hologic; Names New CEO

By MedTech Intelligence Staff

Hologic announced the appointment of José (Joe) E. Almeida as Chief Executive Officer, effective immediately upon closing of the previously announced company acquisition.

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April 10, 2026

Endospan Receives FDA Approval for the NEXUS Aortic Arch Stent Graft System

By MedTech Intelligence Staff

The FDA has approved the NEXUS Aortic Arch Stent Graft enabling commercial launch of the NEXUS System in the US.

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April 10, 2026

InVera Medical Receives FDA Clearance for Non-Thermal Chronic Venous Disease Device

By MedTech Intelligence Staff

The InVera Infusion Device is approved for use in the US and EU within its indications.

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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.

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BSC Logo
April 3, 2026
BSC Logo

Boston Scientific receives FDA clearance for the Asurys Fluid Management System

By MedTech Intelligence Staff

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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Columns

October 8, 2026

Cybersecurity by Design: Building Traceable Execution Across the MedTech Lifecycle

How MedTech manufacturers can move cybersecurity upstream, strengthen traceability, and prepare for faster vulnerability response.

August 18, 2026

FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.  

May 20, 2026

Artivion Completes Endospan Acquisition, Expands Aortic Arch Portfolio With FDA-Approved NEXUS System

By MedTech Intelligence Staff

Artivion has finalized its acquisition of Endospan Ltd., adding the FDA-approved NEXUS Aortic Arch System to its portfolio of aortic arch therapies. The deal strengthens the company’s position in the growing endovascular aortic repair market and adds a pipeline of next-generation arch technologies.

May 19, 2026

Signatera CDx Gets FDA Nod as Companion Diagnostic for Muscle-Invasive Bladder Cancer

By MedTech Intelligence Staff

Marks the first FDA-approved use of personalized molecular residual disease (MRD) testing to guide treatment decisions and solidifies Natera’s Treatment on MRD (TOMR) approach for MIBC care.

May 19, 2026

Boston Scientific announces strategic investment in MiRus LLC

By MedTech Intelligence Staff
Boston Scientific Logo

Agreement includes exclusive option to acquire novel, balloon-expandable transcatheter aortic valve made with proprietary rhenium alloy

May 11, 2026

Roche acquires PathAI to transform AI-driven diagnostics

By MedTech Intelligence Staff

PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities, according to the company Roche, will complement the company's digital pathology portfolio to drive laboratory efficiency.

May 4, 2026

Medtronic’s Updated Mitral Valve, Mosaic Neo, Gets FDA approval

By MedTech Intelligence Staff
Medtronic

Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally Invasive Cardiac Surgery (MICS) and robotic cases.

May 4, 2026

Sonire Therapeutics Initiates First U.S. Clinical Study of Ultrasound-Guided HIFU Therapy for Pancreatic Cancer

By MedTech Intelligence Staff
Sonire Therapeutics

SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach

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