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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

Podcast: Legal Expert Advises On Patentable Subject Matter As Courts Send Conflicting Message

Three major cases have provided different interpretations of what is considered patentable subject matter, and to top it off a new guideline from the US Patent and Trademark Office has added to the confusion, according to a legal expert. Harness Dickey’s Chris Cauble walks us through what patent-seekers need to know and how to prepare their patent filings in this interview (podcast and transcript).

Intellectual Property Innovation

Medtronic Plans To Issue Software Fix In Second Half Of 2019 Following Pulse Generator Recall

US FDA has designated Medtronic implantable pulse generators that could cause the product leads to fail as a class I recall. The company says health-care providers for patients implanted with the IPGs should change the device settings for the time-being until it can issue a software update, which is estimated to be completed sometime in the second half of the year.

Recalls Safety

Medtech Security Organization Adopts Widely Used Automation Cybersecurity Standard

The medtech cybersecurity group MDISS says it will adopt the ISA/IEC 62443 cybersecurity standard that has been widely used in an array of industries for the medical device industry. This comes following news from the European medtech group COCIR that it was also considering adopting the standard.

Cybersecurity Standards

New Device Tax Repeal Bills Are Coming, With Candidate Klobuchar's Help

Despite a recent report that Sen. Amy Klobuchar, D-Minn., is backing away from leading efforts to repeal the medical device tax due to her presidential ambitions, sources say she is working with Sen. Pat Toomey, R-Pa., to cosponsor a repeal bill this year. Similarly, on the US House-side, Rep. Ron Kind, D-Wisc., is calling on his colleagues to support a full repeal bill as well.

Legislation Lobbying

Muddy Waters Short-Sells Inogen, Citing Inflated Market Projections

The short seller that took on St. Jude Medical two years ago on cardiac-device cybersecurity now is targeting Inogen, maker of portable oxygen concentrators. Muddy Waters says the research firm that projected Inogen’s market penetration is way off and the company’s leadership is far too optimistic.

Cybersecurity Business Strategies

CDRH Will Experiment With Pre-Cert Pilot Participants To Figure Out Right Metrics, Processes

With a regulatory framework and test plan in place, US FDA says it will use the rest of the year to run experiments in its pre-cert pilot program to figure out what metrics it needs to gather and processes it needs to develop to make the new paradigm for digital health products a reality. The agency says it plans to update stakeholders as needed on its progress.

Digital Health Regulation
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