Anika's Integrity™ Implant System Granted 510(k) Clearance for Rotator Cuff Repair Augmentation

Complete Integrity Implant System is now fully cleared; targeting launch in Q1-2024 Integrity is highly differentiated by its knitted structure, resulting...

August 21, 2023 | Monday | News
Sequel Spiral™ Tampon Receives FDA Approval as Medical Device

-Sequel, a startup, dedicated to engineering better health and wellness experiences for women, today announced that its breakthrough spiral tampon has rece...

August 16, 2023 | Wednesday | News
GE HealthCare's Portrait Mobile Gets FDA Nod for Wireless Patient Monitoring

GE HealthCare’s smart phone-sized Portrait Mobile frees the patient from the hospital bed while providing continuous monitoring of vital signs, usi...

August 15, 2023 | Tuesday | News
Imperative Care Unveils New Structure to Elevate Care for Patients with Vascular Diseases

-Imperative Care, Inc., a medical technology company elevating care for people affected by stroke and other ischemic diseases,  announced a new organi...

August 11, 2023 | Friday | News
Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablati...

August 09, 2023 | Wednesday | News
Etiometry's AI Algorithm FDA Cleared to Alert Neonatal Hypercapnia Risk

Etiometry, the leader in clinical decision-support software, announced today its IVCO2 Index™was cleared by the Food and Drug Administration for use ...

August 03, 2023 | Thursday | News
Synaptive Medical Welcomes Provincial Investment to Expand Manufacturing and R&D Activities

The Synaptive MRI is a 0.5T system that was designed to overcome challenges such as accessibility in critical and acute cases like brain tumour and stroke,...

August 03, 2023 | Thursday | News
STERIS Completes the Acquisition of Surgical Instrumentation Assets from BD

“We are pleased to announce the closing of this acquisition, as the brands we are adding will strengthen, complement and expand STERIS’s produc...

August 03, 2023 | Thursday | News
FDA Streamlines Innovation for Opioid Use Disorder Devices

"The FDA continues to seek new ways to advance science to address the public health challenges that families and communities across the country face," said...

July 28, 2023 | Friday | News
FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

The FDA clearance also includes the company's core technology platform, the proprietary AXINON® System, that incorporates diagnostic testing algor...

July 26, 2023 | Wednesday | News
DuoPharma Biotech to scale screening device iBreastExam across Malaysia

Malaysia’s leading pharmaceutical company, Duopharma Biotech Berhad (“Duopharma Biotech”) through its wholly-owned subsidiary, Duopharma ...

July 25, 2023 | Tuesday | News
Advanced FDA Cleared Magstim Horizon 3.0 TMS Now Available in United Kingdom

The advanced and FDA-cleared Magstim Horizon 3.0 transcranial magnetic stimulation (TMS) system is now UKCA registered and available for sale in the UK, pr...

July 10, 2023 | Monday | News
Kalos Medical's DENEX Hypertension Treatment System Earns Korean MFDS Innovative Medical Device Designation

The DENEX system is an innovative medical device that treats hypertension using minimally invasive renal denervation technology. Electrodes are inserted in...

June 28, 2023 | Wednesday | News
ZEISS Accelerates Validation Process for Coordinate Measuring Machines to Achieve FDA Compliance

Validation is a required component of medical device quality assurance. But device manufactures new to CMMs find it challenging to validate the software an...

June 23, 2023 | Friday | News

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