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.
Long COVID-19 Survivors Report Effects Following Recovery
According to a systematic review consisting of 57 studies and including 250,000+ patients, more than 50% patients with long COVID (persistent postacute sequelae of COVID-19 or PASC) described feeling effects of COVID beyond six months after recovery. The results...
Migraines: Canada Gives Regulatory Approval for ElectroCore
electroCore, a leading bioelectronic medicine company, have received a revised Medical Device License (MDL) from Health Canada to extend its labelling of electroCore’s gammaCore nVNS to include the acute and preventive treatment of migraine in adolescents (aged 12 -...
Breast Cancer: FDA Approves Eli Lilly Verzenio Inhibitor
Eli Lilly and Company has received FDA approval from the US FDA (Food and Drug Administration) for the first and only CDK4/6 inhibitor for a specific group of people with Breast Cancer. Verzenio, abemaciclib, aims to treat adult patients with hormone receptor-positive...
Genematrix NeoPlex HPV 29 Detection Gains European CE-IVD
Genematrix, known for their real-time PCR based molecular diagnostics, have announced that NeoPlex HPV29 Detection has gained European Medical Device Certification (CE-IVD). Designed to simultaneously diagnose 29 genotypes of human papillomavirus (HPV - a key...
Medtronic Hugo Robotic Surgery System Granted European CE Mark
A global leader in medical technology, Medtronic, has been granted CE (Conformité Européenne) Mark for the Hugo™ robotic surgery (RAS) system, giving the green light for sales of the system in Europe. The approval has been given for urologic and gynecologic procedures...
Healthcare AI Technology: Beyond Mental Health and Diabetes
For those following our series on AI in communications, or for anyone closely watching developments in the life sciences, it won’t come as news that technology is one of the most promising new tools for solving challenges in health care and developing new treatments....
FDA Approves ChemoCentryx Drug for Rare Autoimmune Disease
ChemoCentryx has received US FDA (Food and Drug Administration) approval for their drug, avacopan, to treat the rare, fatal autoimmune disease, antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV). The oral drug, brand name Tavneos, will help those...
Finland, Sweden & Denmark Limit Moderna COVID-19 Vaccine
Following the release of a Nordic study, Finland joins Sweden and Denmark in pausing the distribution of the Moderna COVID-19 vaccine for young adult males (under 30) after reports of a rare cardiovascular side effect. The unpublished study will be sent to the...
J&J Submits Booster Emergency Use Authorization to FDA
Johnson & Johnson (J&J) has submitted its data to the US FDA (Food and Drug Administration) for emergency use authorization for its booster shot of the J&J COVID-19 vaccination. The submission is based on the Phase 3 ENSEMBLE 2 study that shows that a...
Acute Lymphoblastic Leukemia (ALL): First Approved CAR T-Cell
The US FDA (Food and Drug Administration) has approved the first-ever chimeric antigen receptor (CAR) T-cell therapy, brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company) for adults with relapsed or refractory acute lymphoblastic leukemia (ALL). The approval...
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