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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

MTI Profile: US FDA's Second-In-Command Has Her Eye On A Tech-Forward Future

As principal deputy commissioner of the FDA, Amy Abernethy is focused on developing overarching policies that affect all its product centers. But perhaps what will stand as her legacy is her work to develop a data-centered strategy to improve how the agency reviews products and ensures their long-term safety and efficacy.

Leadership FDA

Top FDAer Skeptical Of Wearable Devices, Says Agency Is Working To Improve Standards And Technology

Amy Abernethy, the principal deputy commissioner at the US FDA, told attendees at a 25 July medical conference that she's somewhat skeptical about using wearable technologies for clinical needs because they still haven’t proven their accuracy. However, she says the device center is working hard to develop new standards for such products and is looking for funding to develop them.

Regulation Digital Health

Device Week, 9 August 2019 – Safety Concerns With Cardiac Devices; User Fees Go Up

In this week's podcast, Medtech Insight’s Ferdous Al-Faruque chats with Elizabeth Orr about the the latest safety concerns over cardiac devices such as drug-eluting stents and implantable cardioverter defibrillators. They also discuss the agency’s recently released user-fee rates and how they’ve increased historically.

Device Week Regulation

New Heartache For Abbott Implantable Cardiac Devices After Manufacturing Flaw Discovered

US regulators have notified the public about a recall of certain Abbott Ellipse implantable cardioverter defibrillators that are prone to electrical shorting due a manufacturing flaw. While the number of devices so far in the US is very small, the recall highlights continued issues with the ICDs since Abbott acquired them from St. Jude almost three years ago.

Regulation Safety

Medtech Firms To See Significant User Fee Increases In FY 2020

Most categories of medical device user fee applications will be 6% more expensive starting in October. Establishment registration fees will see more than a 7% increase as well, regardless of whether a company is considered a small business.

Regulation Approvals

A Brave New World: Regulatory Flexibility Key To AI Development, Stakeholders Say

About 130 stakeholders representing a broad spectrum of the health-care industry are asking the US FDA to consider taking a soft touch in any future guidance document addressing artificial intelligence and machine learning devices in order to keep up with developments in the field. Drug lobbyists have also asked the agency to develop guidance that reaches across centers to avoid future conflicts.

Regulation Digital Health
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