Currently, we live in a world driven by the 4th Industrial Revolution in which science and technology are continuously evolving. But what exactly is Industry 4.0? It is the process of using tech platforms like Cloud, IoT, AI, and Analytics...
I think I can speak for most people when I say that viable treatments and vaccines are desperately needed at this point to overcome the COVID-19 global pandemic. Not only that COVID-19 has taken so many lives across the globe,...
In recent years, the field of regenerative medicine has gained significant traction and been pointed to as the future wave of medicine. Regenerative medicine focuses on replacing tissues or organs that have been damaged by disease or other conditions and...
The US Food and Drug Administration released a final rule to exempt additional product codes from the requirements of 510(k) submission. FDA believes that this exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs...
A rising trend in the medical and computer science industries is Cloud Computing, or what is commonly known as a platform for “Storage”. When coupled with cutting-edge technologies such as the Internet of Things (IoT) and Machine Learning (ML), it...
How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind...
Are you looking to expand your consumer base and grow your business? International marketing is beneficial by creating long-term business relationships and increasing brand reputation. Expanding your market to a country like Australia is a smart commercial move, but how...
Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, there is a rush to get diagnostic tests and other medical products to detect and treat the emergency available quickly. Given...
The transition to the new EU MDR and IVDR tops the list this year with the concerns and confusion it continues to create within the industry. With a limited number of guidance documents to guide the device makers, companies are...
The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that claims medicinal benefits. While those in the cosmetic industry use the term to advertise the ingredients and benefits of their products, the FDA does not...