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Ferdous Al-Faruque

Senior Reporter

Washington, DC

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

Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates

In this roundup of developments in digital health, we highlight the key news and announcements from August and September.

Digital Health Artificial Intelligence

FDA: Keep Cybersecurity Vulnerabilities Messaging Short And Simple

The US agency published a paper that’s based on recommendations from experts and other stakeholders on how to best let patients know their device may be vulnerable to a cybersecurity attack.

Cybersecurity Safety

MDUFA IV Report: US FDA Needs To Publish Digital Health Guidance

Booz Allen Hamilton’s report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.

Regulation Policy

Pentagon Forks Over Another $109M To Make OraSure’s COVID-19 Antigen Test

The latest funding would upgrade OraSure’s Pennsylvania plant, build a new factory and increase production of its antigen test by 100 million units by 2024.

Commercial Companies

Device Week, 1 October 2020 – MDUFA And MCIT In Spotlight At AdvaMed's MedTech Conference

In this week’s podcast, reporters discuss the high points of the recent AdvaMed MedTech Conference. Ferdous Al-Faruque goes in-depth on FDA comments about user fees, while Brian Bossetta discusses varying points of view on Medicare coverage of breakthrough devices – including the crucial role of real-world evidence.

Device Week Regulation

Aggregating Adverse Events Data Should Be Sponsor Responsibility: FDA

The US agency has published a draft guidance outlining investigator and sponsor responsibilities in which it says sponsors are better suited to report aggregated adverse events to regulators.

Clinical Trials FDA
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