On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s...
Seneca Biopharma announced today (1/20) its preliminary top-line results for their Phase 2 ischemic stroke study. The trial, which took place in Beijing, China, focused on evaluating the relative safety of NSI-566, a neural stem cell therapy, in patients afflicted...
The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as...
The European Medicines Agency (EMA) issued a draft guidance yesterday (1/14) for medicines intended to be used in low- to middle-income countries outside the European Union (EU). The Article 58 process calls for EMA’s Committee for Medicinal Products for Human Use...
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 (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...
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, 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...
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...
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...
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