Ferdous Al-Faruque
Senior Reporter
Ferdous Al-Faruque, known as Danny, specializes in reporting on new medical device technologies such as mobile health, combination products, unique device identifiers, and issues surrounding interoperability and cyber security. He is also our resident podcast expert, and has brought listeners the voices of top FDA officials as well as industry leaders. Danny is a big sci-fi fan, especially Battlestar Galactica and Star Trek. Qapla'!'}">Ferdous Al-Faruque, known as Danny, specializes in reporting on new medical device technologies such as mobile health, combination products, unique device identifiers, and issues surrounding interoperability and cyber security. He is also our resident podcast expert, and has brought listeners the voices of top FDA officials as well as industry leaders. Danny is a big sci-fi fan, especially Battlestar Galactica and Star Trek. Qapla'!
Latest From Ferdous Al-Faruque
FDA Will No Longer Regulate Certain Medical Software
The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
US FDA Nukes HHS Decision To Exempt Medical Gloves, Other Products From Regulatory Oversight
The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.
Digital Health Roundup, March 2021: Record-Breaking Funding; Exec Chats With Medtronic, Edwards LifeSciences
In this new roundup feature focusing on the most notable developments in digital health, we pick the key news to date.
FDA Authorizes GI Genius As A Smarter AI-Based Colonoscopy Tool
According to a large clinical study, the first such device with AI-enabled software is better at detecting potential lesions than traditional colonoscopies and could allow detection of colon cancer sooner.
Device Week, 9 April 2021 – A Look At The EUA Process For Lucira Health, Ellume COVID-19 Tests
In this week’s case study podcast we discuss first-of-their-kind US FDA emergency use authorizations for at-home COVID-19 diagnostics made by Lucira Health and Ellume.
FDA Plans To Improve COVID-19 EUA Process, Inspection Work Based On Report Recommendation
The agency is taking to heart several recommendations made by an independent reviewer earlier this year in a report on its COVID-19 response.