Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
Medtronic Launches NuVent™ Eustachian Tube Dilation Balloon
Medtronic plc has announced the launch of the NuVent™ Eustachian tube dilation balloon, which has been cleared by the U.S. Food and Drug Administration (FDA) for treating chronic, obstructive Eustachian Tube Dysfunction. The NuVent™ balloon serves as an alternative...
New Requirements for Clinical Trial Translations: EU-CTR Provisions to Informed Patient Consent
Within clinical trial translations, informed patient consent forms (ICFs) are an important and mandatory prerequisite for all submissions that not only represent the patient’s individual rights but also serve as an underlying principle of medical ethics. Under the...
FDA Clears Viz.ai’s Cerebral Aneurysm Detection Module
Viz.ai has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz ANEURYSM, a new algorithm that uses artificial intelligence (AI) to detect suspected cerebral aneurysms. The intention is to ensure that patients receive...
FDA Breakthrough Device Designation for Epilepsy Treatment
Precisis GmbH has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Epicranial Application of Stimulation Electrodes for Epilepsy (EASEE) brain stimulator to treat epilepsy. EASEE is a system for individualized brain...
FDA Clearance: LBPs to Treat Parkinson’s Disease
4D pharma plc announced that the FDA has cleared IND applications for two Live Biotherapeutics (LBPs), MRx0005 and MRx0029, for the treatment of Parkinson’s disease. Parkinson’s disease, which impacts more than 10 million people worldwide, is a progressive...
Swissmedic Approval: BeiGene’s BRUKINSA to Treat WM
BeiGene has announced their Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA (zanubrutinib) has been approved by Swissmedic to treat adult patients with Waldenström’s macroglobulinemia (WM). WM is a rare B-cell lymphoma that is primarily found in bone marrow and...
LEXEO Therapeutics: IND Clearance for LX2006 AAV-based Gene Therapy
The US Food and Drug Administration (FDA) has cleared LEXEO Therapeutics’ Investigational New Drug (IND) application for LX2006, an adeno-associated virus (AAV)-based gene therapy candidate to treat Friedreich’s ataxia cardiomyopathy (FA cardiomyopathy). FA...
Tandem Diabetes Care: FDA Clearance for Insulin Pump Using Mobile App
Tandem Diabetes Care today announced a US Food and Drug Administration (FDA) clearance of a bolus insulin dosing feature on the t:slim X2 insulin pump using the t:connect mobile app. This case is the first-ever FDA-cleared smartphone application capable of initiating...
AffaMed: IND Clearance for AM712 to Treat Retinal Diseases
AffaMed Therapeutics’ Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712), a novel proprietary bispecific biologic molecule, has been cleared by the US Food and Drug Administration (FDA). AM712 has been designed to treat retinal...
Axcella: FDA Fast Track for AXA1125 to Treat NASH
The US Food and Drug Administration (FDA) has granted a Fast Track Designation to Axcella Therapeutics’ AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. NASH is the most severe form of fatty liver disease and if left untreated, can lead to...
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