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 Announces First Enrollment of Adaptive Deep Brain Stimulation (aDBS) Trial for Parkinson’s Patients
Medtronic announced today (1/14) the launch of its clinical trial enrollment of the innovative Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD). The novel trial, which will take place across 12 research study sites in the US, Europe...
The European Commission Announces Acceptance of Remote Audits Amidst COVID-19
The European Commission (EC) announced this week that it will now be accepting remote audits during the pandemic for some European medical device and in vitro companies. The cleared pathway comes in time for upcoming deadlines in May 2021 and 2022 for the EU’s MDR...
EMA Grants Orphan Drug Designation for NeuroSense Therapeutic’s ALS Drug Therapy
The European Medical Association (EMA) granted NeuroSense Therapeutics, a clinical stage drug development company, orphan drug designation today (1/12) for PrimeC, a unique combination drug for treatment of Amyotrophic Lateral Sclerosis (ALS). The U.S. Food and Drug...
Abbott Laboratories Announces FDA 510(k) Clearance for Innovative Rapid Handheld Blood Test for Mild TBIs
Abbott Laboratories, a multinational health care and medical device company, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making history as the first ever handheld blood test for traumatic brain injuries (TBIs). The...
The FDA Tracks COVID-19 Mutations Impact on Diagnostic Performance
On Wednesday (1/6) the U.S. Food and Drug Administration (FDA) announced that it is tracking the COVID-19 testing diagnostics with SARS-CoV-2 test developers to determine the efficacy of the already-approved tests on their ability to detect new COVID-19 variants. The...
FDA Grants Fast Track Designation for Gemini Therapeutics’ Treatment GEM103
Today (1/7) Gemini Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted GEM103 treatment of dry age-related macular degeneration (AMD) for Fast Track designation. Gemini Therapeutics is a clinical stage precision medicine company based in...
The Diversity of India and Its Impact on the Global Clinical Trial Landscape
With a population of more than 1.3 billion people, India is one of the fastest growing economies in the world. As their global economy continues to expand, and as clinical trials are continuing to be conducted overseas, India remains unique in both the opportunities...
FDA Releases Statement Urging Healthcare Providers to Follow Proper Dosing Schedules
The U.S. Food and Drug Administration (FDA) released a statement on Monday (1/4) urging healthcare providers to follow the approved dosing schedules for COVID-19 vaccinations, after discussions of changing doses, limiting doses, and extending length of time in between...
FDA Clears BioSerenity’s Electroencephalography (EEG) Wearable Device
Today (1/5) BioSerenity announced that the U.S. Food and Drug Administration (FDA) cleared the Neuronaute® EEG System and IceCap® EEG wearable device. The device is designated for patients diagnosed with epilepsy, and will enable physicians to remotely monitor and...
NDA Submitted by Antengene in South Korea
Antengene submitted yesterday (1/3) a New Drug Application (NDA) with Orphan Drug Designation (ODD) to South Korea’s regulatory body, the Ministry of Food and Drug Safety (MFDS), for ATG-010 (selinexor). The NDA is specifically for the approval of ATG-010 (selinexor)...
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