Regulatory Approvals

ZOLL achieves EU MDR approval for Zenix device

February 12, 2026

Digital X-ray company Nanox scores first FDA clearance

April 5, 2021

The company's device promises to change the way medical imaging is used and make it much more widely available by cutting the cost. Israeli imaging...

FDA grants Oxehealth Vital Signs De Novo clearance; Oxehealth launches in the US

April 1, 2021

Vision-based patient monitoring and management company will focus on skilled nursing facilities, where its technology service can help clinicians deliver safer, higher quality and...

Caristo Diagnostics announces EU approval for AI technology that can predict heart attacks years in advance

March 30, 2021

Research funded by us has led to EU-approved artificial intelligence (AI) technology that can identify people at high risk of a fatal heart attack...

FDA Grants Breakthrough Device Designation to Tempus’ Atrial Fibrillation ECG Analysis Platform, Developed in Collaboration With Geisinger

March 29, 2021

Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough...

GE Healthcare Gains FDA Clearance of New 3D Surgical Imaging

March 26, 2021

GE Healthcare was granted FDA 510(k) clearance to market OEC 3D, a new surgical imaging system capable of 3D and 2D imaging. This new system combines...

Medtronic secures CE mark for directional lead system for deep brain stimulation

March 24, 2021

Medtronic plc obtained the CE mark for its Sensight directional lead system for deep brain stimulation (DBS) for movement disorders and epilepsy, which is designed...

LimFlow Receives Japan PMDA Approval for Clinical Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients

March 24, 2021

LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery...

Boston Scientific receives FDA approval for TheraSphere device

March 22, 2021

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval of the TheraSphere Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma...

Life Spine Announces FDA 510(k) Clearance for the PROLIFT® Wedge Expandable Spacer System

March 19, 2021

Life Spine, a leading medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that...

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ZOLL achieves EU MDR approval for Zenix device

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

Kandu trial highlights positive outcomes with IpsiHand BCI 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

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

Berlin Heals raises $10M to expand its new less invasive approach

Neurent raises $74M to accelerate chronic rhinitis treatment launch

NuVision Biotherapies raises £4.8m to boost overseas expansion

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

Regulatory Approvals

ZOLL achieves EU MDR approval for Zenix device

GS MedTech Funding Tracker – Neurent, Aerska, and more

Kandu trial highlights positive outcomes with IpsiHand BCI system

Berlin Heals raises $10M to expand its new less invasive approach

ZOLL achieves EU MDR approval for Zenix device

GS MedTech Funding Tracker – Neurent, Aerska, and more

Kandu trial highlights positive outcomes with IpsiHand BCI system

Berlin Heals raises $10M to expand its new less invasive approach

ZOLL achieves EU MDR approval for Zenix device

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