Regulatory Approvals

Vesalio earns CE marks for vasospasm, thrombectomy treatments

February 11, 2026

LivaNova LifeSparc ACS pump cleared for extended use

November 21, 2022

LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane...

FDA clears Neocis surgical robot for bone reduction

November 16, 2022

Neocis announced that it received FDA 510(k) clearance for its Yomi surgical robot system for use in guided bone reduction. This represents the second FDA clearance...

Chocolate Touch drug-coated angioplasty balloon for treatment of peripheral artery disease receives FDA approval

November 15, 2022

Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter developed...

Accelus Wins FDA 510(k) Clearance for Remi Robotic Navigation System Software Update

November 14, 2022

Accelus has announced that the U.S. Food & Drug Administration (FDA) had cleared its 510(k) application for its Remi™ Robotic Navigation System software update...

Caption Health Receives Regulatory Approvals for Caption AI™ Technology Platform in Canada and Australia

November 11, 2022

Caption Health, the leader in using AI and services to improve access to heart ultrasound diagnostics, announced new regulatory approvals to market its Caption...

Baebies Receives FDA 510(k) Clearance for G6PD Test on FINDER Platform

November 10, 2022

Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. The test is run...

ProciseDx Announces FDA Clearance of ProciseDx instrument and C Reactive Protein (CRP) Assay

November 9, 2022

ProciseDx Inc. announces FDA clearance of its ProciseDx instrument and C reactive Protein (CRP) test. Procise CRP gives quantitative determination of CRP levels in patient serum...

Exactech’s TriVerse primary knee system obtains FDA 510(k) clearance

November 8, 2022

The TriVerse primary knee system aims to provide cruciate retaining along with anterior and posterior stabilised constructs. Exactech has obtained 510(k) clearance for its TriVerse primary knee replacement...

ABM Respiratory Care receives CE Mark Certification for BiWaze® Cough

November 4, 2022

ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced it has received...

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Vesalio earns CE marks for vasospasm, thrombectomy treatments

Sonorous Neurovascular earns FDA breakthrough mark for novel stent

Median Technologies receives FDA 510(k) clearance for eyonis LCS, an AI-based detection and diagnosis device for lung cancer screening

Eyas Medical Imaging wins FDA 510(k) clearance for the Ascent3T neonatal magnetic resonance imaging system

CorTec announces successful second human implantation of its BCI system

Atraverse reports positive data for Hotwire transseptal access system

Artivion’s aortic stents boost post-surgical outcomes in interventional studies

Biotronik completes first human implants of LivIQ leadless pacemaker

Stryker introduces Mako Handheld Robotics with Mako RPS launch

Leadoptik reports first-in-human use of lung biopsy tech

Spineology launches innovative patient-specific spinal implant

Zimmer Biomet launches new foot and ankle system

Medtronic advances its innovation strategy with intent to acquire CathWorks

Rein Medical becomes part of the Reinsberg Group

BioStem acquires BioTissue’s surgical and wound care assets in $40M deal

Zylox-Tonbridge to acquire German medical technology company Optimed

NuVision Biotherapies raises £4.8m to boost overseas expansion

Stratus Medical raises $10M Series B to complete development of new technology

SonoVascular raises $6M Series A to support thrombectomy system

Bluedrop Medical picks up $1.2M for diabetic foot ulcer detection tech

Regulatory Approvals

Vesalio earns CE marks for vasospasm, thrombectomy treatments

Vesalio earns CE marks for vasospasm, thrombectomy treatments

CorTec announces successful second human implantation of its BCI system

Atraverse reports positive data for Hotwire transseptal access system

Stryker introduces Mako Handheld Robotics with Mako RPS launch

Vesalio earns CE marks for vasospasm, thrombectomy treatments

CorTec announces successful second human implantation of its BCI system

Atraverse reports positive data for Hotwire transseptal access system

Stryker introduces Mako Handheld Robotics with Mako RPS launch

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