Regulatory Approvals

HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

December 18, 2024

Gala Therapeutics Receives FDA Approval to Commence Pivotal Trial to Evaluate the RheOx™ System for Chronic Bronchitis

February 24, 2021

Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announces U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption...

Brainlab Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module for Spine Both Receive FDA clearance

February 23, 2021

Brainlab announced today that the company has reached two major milestones with the FDA clearance for both Loop-X® Mobile Imaging Robot and Cirq®, a robotic...

AI-based voiceprint screener for COVID-19 nets European approval

February 22, 2021

From taste and smell to muscle aches and “COVID toes,” the coronavirus affects the body in a variety of ways—including small changes in a...

OpSens Obtains CE Marking for the OptoWire III

February 19, 2021

OpSens Inc. ("OpSens" or the "Company") (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company commercializing a second-generation fiber optic pressure guidewire to diagnose and treat coronary...

Infant monitoring tech brand Owlet announces SPAC merger for Q2 2021

February 18, 2021

The company currently sells connected wearables and smart monitors to consumers but said that it will be seeking FDA authorization for new products with...

Stroke treatment device from Israel’s BrainQ wins FDA ‘breakthrough status’

February 15, 2021

Only about 5% of victims in the US currently arrive at the hospital in time to benefit from currently approved treatments. BrainQ's AI-based device...

FDA greenlights Visby Medical’s single-use, portable PCR test for COVID-19

February 12, 2021

Visby Medical received a new emergency authorization from the FDA for its rapid, single-use PCR test designed to detect COVID-19 infections at the point...

First Case with HipInsight Augmented Reality for Joint Replacement

February 11, 2021

Surgical Planning Associates (SPA) today announced a major step forward in how surgery can be performed with the introduction of its HipInsight augmented reality (AR)...

ShiraTronics, Inc. receives FDA Breakthrough Device Designation for Chronic Migraine Neurostimulation

February 10, 2021

ShiraTronics, Inc. a privately held medical device company, announced that it has been granted a Breakthrough Device designation by the Center of Devices and...

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Precision Neuroscience raises $102M to support BCI

Flow Medical secures $2m to advance breakthrough thrombolysis catheter for pulmonary embolism treatment

Fluid Biomed raises $27m to advance ReSolv brain aneurysm stent

ENEA-Tech Biomedical foundation invests €6m in BetaGlue Therapeutics

SamanTree Medical’s Histolog scanner shows promise in breast surgery outcomes

Protaryx Medical completes first-in-human trial of transseptal puncture device

EndoQuest wins FDA IDE to study surgical robot in colorectal surgery

ShiraTronics initiates FDA IDE study for implantable neuromod

Verathon launches sustainable single-use laryngoscope

VUZE Medical demonstrates new multi-tool 3D guidance in spine surgery

Globus Medical launches ExcelsiusHub navigation system

Vascular stent graft maker Solaris Endovascular launches to address vascular health challenges

HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

Cercare Medical secures FDA clearance for CT Perfusion Imaging software

Liquet Medical receives FDA 510(k) clearance for the Versus catheter

FemPulse wins FDA IDE for for overactive bladder neuromod

DHG boost market-leading pressure ulcer prevention portfolio with Sumed acquisition

Wellvii, B-Secur partner to integrate ECG into at-home monitoring tech

Flat Medical acquires InjeQ’s IQ-Tip needle system

Vitalograph acquires respiratory diagnostics company Morgan Scientific

Regulatory Approvals

HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

Precision Neuroscience raises $102M to support BCI

Flow Medical secures $2m to advance breakthrough thrombolysis catheter for pulmonary embolism treatment

HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

Cercare Medical secures FDA clearance for CT Perfusion Imaging software

Precision Neuroscience raises $102M to support BCI

Flow Medical secures $2m to advance breakthrough thrombolysis catheter for pulmonary embolism treatment

HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

Cercare Medical secures FDA clearance for CT Perfusion Imaging software

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

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland

FDA clears portable blood, IV fluid warmer from Mequ

Editors’ Choice: Q1 2024 in MedTech