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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'!
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Latest From Ferdous Al-Faruque

In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium

As the 2017 window to fully repeal the medical device tax has all but closed, lawmakers and industry are now focusing on another extended moratorium of the tax. A new bill proposes to give medical device-makers more time without the tax to develop business plans and more breathing room for Congress to consider a full repeal. Medtech Insight speaks with co-sponsor Rep. Erik Paulsen and industry advocates.

Legislation Business Strategies

Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work

US FDA dropped three big digital-health guidances related to medical software as part of its initiative to help to streamline a path to market for a sector that is "increasingly embraced" by the health system and needs regulatory certainty, according to agency. But initial industry reaction to perhaps the most highly anticipated of the document, on clinical-decision-support software, is somewhat critical.

Regulation Digital Health

Shuren: More Than A Dozen MDDTs Under Review, But No More This Year

The head of US FDA's device center says there are a substantial number of medical device development tools under review by the agency that could help speed up data collection for product approvals and clearances, but they are not likely to be OK'd by the agency until next year.

Regulation Clinical Trials

3D-Printing Final Guidance Clarifies Manufacturing Practice Expectations

A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology. The final guidance makes minor clarifications, but for the most is identical to the draft.

Regulation Manufacturing

First Expedited NGS Test Breaks Through FDA Review

FDA has approved FoundationOne CDx, the first next-generation sequencing test to clear the agency's expedited access pathway as a breakthrough-designated diagnostic. The companion diagnostic also nabbed a positive national Medicare coverage propose simultaneously thanks to the FDA/CMS Parallel Review Program.

Regulation Reimbursement

Dems Come Out Swinging During Azar Senate HELP Committee Hearing

During his first Senate confirmation hearing, top Democrats attacked Trump HHS secretary nominee Alex Azar for his ties to the pharmaceutical industry and support of right-wing ideology espoused by the White House.

Legislation Leadership
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