Regulatory Approvals

Adagio Medical wins FDA IDE to expand ventricular ablation study

April 10, 2026

Neurescue’s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest

June 11, 2021

Device is FDA IDE approved to start a clinical study in the U.S. to investigate a novel cardiac arrest treatment indication Neurescue, a medical device...

Ibex Granted FDA Breakthrough Device Designation

June 10, 2021

Ibex Medical Analytics, a specialist in AI-powered cancer diagnostics, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which...

Cognoa’s AI app for diagnosing childhood autism gets FDA green light

June 4, 2021

In a first for the use of artificial intelligence in healthcare, the FDA has given a green light to a program designed to help...

AI triage solution for deadly vascular conditions receives FDA clearance and CE Mark

June 3, 2021

Avicenna.AI announces the introduction of CINA CHEST, including AI tools for detection and emergency triage of pulmonary embolism and aortic dissection Medical imaging AI specialist Avicenna.AI announced...

Mental Healthtech Woebot Gets FDA Breakthrough Device Designation

June 1, 2021

WB001 is the first digital therapeutic designed to reduce the burden of postpartum depression Woebot Heath, a pioneer in the development of relational technologies and tools to...

iRhythm gains two FDA approvals for updates to its Zio system

May 28, 2021

iRhythm Technologies has announced two US Food and Drug Administration (FDA) 510K clearances—one for a new and improved design of its flagship monitor and...

Ibex AI-enabled breast cancer diagnostic lands CE mark

May 27, 2021

Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform. Tel Aviv, Israel–based Ibex’s Galen platform uses...

Boston Scientific Completes CE Mark for EXALT Model B Single-Use Bronchoscope

May 26, 2021

Boston Scientific Corporation (NYSE: BSX) announced it has completed CE Mark for the EXALT™ Model B Single-Use Bronchoscope, a single-use device designed for bedside...

JenaValve Technology Receives CE Mark for its Trilogy™ TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis

May 26, 2021

JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement)...

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Adagio Medical wins FDA IDE to expand ventricular ablation study

Anumana receives FDA clearance for ECG-AI Cardiac Amyloidosis algorithm, using a standard 12-Lead ECG

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation

FDA grants 510(k) clearance for Allevion Medical’s Vantage system

FeelTect launches vein ulcer monitoring study at University of Galway

Data supports Boston Scientific Watchman FLX in stroke reduction

iPerf enrolls first patient in study of dual-flow femoral artery cannula

Providence Medical enrols first patients in CORUS-LX system trial

Egg Medical unveils new radiation protection system for clinical use

Starlight Cardiovascular reports first baby treated with Lifeline system

Corcym reports first U.S. implantation of next-gen sutureless aortic valve

Stryker launches next-gen syndesmotic fixation device for ankle stabilization

Vernacare acquires Eakin Surgical Limited

Merit Medical acquires View Point Medical for $140M

Embecta to acquire Owen Mumford for up to $199.4M

GE HealthCare completes $2.3B Intelerad acquisition

E2 raises $80M Series C for Hēlo thrombectomy system

Route 92 Medical brings in $50M growth financing

Beacon Biosignals upsizes Series B to $97M

neuroClues closes €10M Series A, bringing total funding to €25M

Regulatory Approvals

Adagio Medical wins FDA IDE to expand ventricular ablation study

Adagio Medical wins FDA IDE to expand ventricular ablation study

FeelTect launches vein ulcer monitoring study at University of Galway

GS MedTech Funding Tracker – Beacon Biosignals, E2, and more

Egg Medical unveils new radiation protection system for clinical use

Adagio Medical wins FDA IDE to expand ventricular ablation study

FeelTect launches vein ulcer monitoring study at University of Galway

GS MedTech Funding Tracker – Beacon Biosignals, E2, and more

Egg Medical unveils new radiation protection system for clinical use

Guided Solutions Celebrates 25 Years of Transforming Executive Search in MedTech

FDA clears NeurAxis’ self-inflating balloon device RED

Guided Solutions Appoints Marco Müller as New Managing Director Germany to Drive Strategic Growth

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland