Regulatory Approvals

ZOLL achieves EU MDR approval for Zenix device

February 12, 2026

FDA approves J&J’s Afib ablation devices for use without fluoroscopy

August 8, 2023

The devices can now be guided with ultrasound which reduces radiation exposure to patients and medical staff. Medical staff will no longer need to wear...

SS Innovations Starts FDA and CE Regulatory Approval Processes for SSi Mantra Surgical Robot

August 3, 2023

SS Innovations International, Inc. has announced that it is beginning the process of applying for FDA and CE regulatory approval for its flagship surgical robotic...

Imeka Receives FDA 510(k) Clearance for ANDI Medical Device

August 2, 2023

Advanced Neuro Diagnostic Imaging (ANDI) software extracts features from medical images to map and analyze microstructural properties of white matter Provides adjunctive information for use...

UltraSight receives FDA approval for AI-based cardiac ultrasound technology

July 31, 2023

UltraSight receives FDA approval for AI-based cardiac ultrasound technology. UltraSight has secured approval from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-based cardiac...

Microbot Medical Announces First Steps to Advance CE Mark for Sales in Europe

July 28, 2023

Microbot Medical Inc. has announced the first steps towards its planned European market clearance, by engaging with a leading Notified Body. The Notified Body will audit...

Imperative Care Announces FDA Clearance of Zoom 88 Support, Designed to Bring the Benefits of Intracranial Access to More Stroke Patients

July 27, 2023

Imperative Care, a medical technology company developing connected innovations to elevate care for people affected by stroke and other ischemic diseases, announced U.S. Food...

Inspira™ Technologies Receives Certification of Medical Devices Quality Management Systems, Another Step Towards EU Regulatory Approval

July 25, 2023

Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a company aiming to revolutionize acute respiratory care, is proud to announce it...

STORZ & BICKEL Announces Certification of Medical Vaporizers Under New EU Medical Device Regulations

July 21, 2023

Certification reinforces STORZ & BICKEL's leadership position in medical device design, ensures continued availability of devices worldwide STORZ & BICKEL GmbH ("STORZ & BICKEL"), the...

FDA Clears ReddyPort® Non-Invasive Ventilation Device

July 20, 2023

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation...

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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