Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

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'!
Advertisement
Set Alert for Articles By Ferdous Al-Faruque

Latest From Ferdous Al-Faruque

Device-Tax Repeal Opportunity Slips Away As GOP Pulls Health Bill From Consideration

The House Republican conference decision to pull the American Health Care Act from consideration means repeal of the medical device tax has died, at least in the short term. After hours of debate on the floor, and failing to gather enough votes to pass the bill, House Speaker Paul Ryan and President Trump called a halt to the Affordable Care Act repeal effort, saying they will now focus on other objectives, such as tax reform.

Policy Legislation

Classified: Next-Gen Sequencing Analyzers, Mobile Glucose Monitoring, Restless-Leg Devices

FDA issued orders officially finalizing regulatory classifications and special controls for next-generation sequencing analyzers; "secondary display" devices for continuous glucose monitor data; and vibratory counter-stimulation devices for restless leg syndrome. And the agency is working towards formalizing 510(k) exemptions for future devices of these types as well.

Diabetic Care In Vitro Diagnostics

Q&A: Mark McClellan Discusses Gottlieb, Cures And More

Former FDA Commissioner Mark McClellan talked with Medtech Insight about FDA Commissioner-nominee Scott Gottlieb, who he has worked closely with in the past at FDA and CMS. He also discussed 21st Century Cures Implementation, President Trump's budget blueprint and more.

Regulation Legislation

FDA Pitches Novel Pathway For Software

In this video from the inaugural Digital Medtech Conference, in San Francisco, FDA's Bakul Patel discusses the agency's thinking behind a proposed "FDA Precheck" program to expedite the path to market for "software as a medical device" products, and industry players respond.

Regulation StartUps and SMEs

Software Fast Track? US FDA Asks Developers To Envision 'Precheck' Program

Developers of "software as a medical device" are unique to other device-makers in how fast their products are developed and updated. FDA digital health leader Bakul Patel is asking companies to provide input on the agency's idea for an expedited pathway for software that would be based on established trust.

Regulation StartUps and SMEs

Video: AdvaMed Puts Digital On Display With San Francisco Meetup

AdvaMed's March 2 Digital Medtech Conference was a coming-out party of sorts for its new Digital division, with members including Apple, IBM and Qualcomm. The meeting brought together tech companies large and small that are exploring the medical arena. Here's a video of Medtech Insight's post-conference chat with AdvaMed Chief Strategy Officer Andrew Fish.

Policy Regulation
See All
Advertisement
UsernamePublicRestriction

Register