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Latest From Ferdous Al-Faruque
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).
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.
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.
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.
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.
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.