North America

Werfen Secures FDA 510(K) Clearance for Aptiva® Tissue Disease Reagent

New Reagent Aids in Diagnosis of Connective Tissue Disease in Hard-to-Diagnose Autoimmune Diseases, Reducing Time to Diagnosis and Improving Patient Outcomes ...

UL Solutions Rolls Out Medical Device Testing in Michigan, Helping the Industry Advance Safety of Healthcare Technology

UL Solutions helps Michigan's growing medical device industry enhance products' safety, security, usability and interoperability with new testing services in Rochester Hills....

DELFI Diagnostics Introduces FirstLook Lung: A Breakthrough in Blood-Based Lung Cancer Screening

FirstLook Lung uses a breakthrough technology of whole-genome machine learning to analyze fragments of cell-free DNA that are markers of cancer in the blood...

Rhaeos, Inc. Receives $1.5 Million Blueprint MedTech Grant from the NIH to Transform Hydrocephalus Management

Rhaeos, Inc, a clinical stage medical device technology company, is pleased to announce that it has been awarded a $1.5 million grant (Federal Award # 1UG3NS130338) from the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) through its Blueprint MedTech program. This grant will further the development of its FDA breakthrough designated medical technology designed to transform the management of hydrocephalus, a neurological condition affecting ove...

care.ai Enhances Nurses' Tools with Google Cloud's AI and Data Analytics

Platform will ease administrative burdens and improve healthcare facility management and patient care ...

4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate

Company Continues to Build Momentum with Most Recent Portfolio Expansion....

Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Patients implanted with the Evoke® System now eligible for full-body MRI scans...

Beyond Air and Getz Healthcare partner to commercialise nitric oxide therapy in APAC

The partnership provides access to hospitals in Australia, New Zealand, Thailand, Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore and Vietnam ...

Japanese medtech startup Medmain to expand to US

The startup develops and provides PidPort, an AI-powered cloud system that supports digital pathology...

Bio-Gate AG signs LOI with North American medical device manufacturer for trauma implants

Bio-Gate AG (ISIN DE000BGAG981), a leading provider of innovative technologies and individual solutions for health and hygiene, has concluded a preliminary agreement (LOI, Letter-of-Intent) with a North American medical device manufacturer focusing on the trauma sector. The medical device manufacturer intends to use Bio-Gate's "HyProtectTM " coating process for its own implants in human medicine following the FDA approval process. ...