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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

FDA's Speedy Apple Watch De Novos Raise Questions For Industry

The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.

Digital Health Regulation

AdvaMed's Top Hill Strategist JC Scott Departs; Greg Crist Will Fill Role

Greg Crist, the top public affairs executive at AdvaMed, is stepping in to head the trade group's government affairs operations, as JC Scott departs to lead the Pharmaceutical Care Management Association.

Appointments Policy

Third-Party Review: FDA Seeks Tangible 510(k) Results Over Next Three Years

Under a new plan and draft guidance issued by US FDA, the agency is hoping to streamline and improve its third-party review program. The goal is to spend substantially less FDA resources re-reviewing low-to-moderate risk 510(k) applications that go through the program and allow products to enter market sooner.

Regulation Medical Device

FDA: Apple De Novo Approvals Signal Innovation To Digital Health Firms

The latest Apple Watch includes an electrocardiogram that has received de novo clearance from US FDA to detect irregular heart rhythms. The approval, say two top US FDA regulators, is a signal to the digital health industry that the agency is trying to help them innovate.

Digital Health Regulation

Government Watchdog Recommends FDA Improve Cybersecurity Reviews

HHS OIG is recommending US FDA hold more pre-submission meetings, amend their Refuse-to-Accept checklist and update their "Smart" template for agency reviewers to improve oversight of medical device cybersecurity.

Regulation Cybersecurity

Shuren: New Uncertainty Draft Guidance Looks Beyond p-Values

After years of talking about how to tackle uncertainty of benefit/risk in devices under review, US FDA has released a guidance on the issue. Medtech Insight caught up with FDA device center director Jeff Shuren at a meeting in Washington, DC, to talk about the guidance and what he hopes will come of it.

Regulation FDA
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