Echosens SA obtained clearance from the U.S. FDA to expand the indications for screening with its Fibroscan system. The approval removes contraindications for pregnancy and active implant and includes patients with confirmed or suspected liver disease. It designates Fibroscan as a noninvasive aid for clinical management, diagnosis and monitoring of adult and pediatric patients with liver diseases. The age has been removed as the first selection probe and exam-type step.
Batteries used in medical devices don’t always perform as expected, but Abbott Laboratories has issued an advisory to users of its Freestyle glucose monitoring systems in connection with overheating of the batteries used in the device’s readers, a problem the company said is not related to the batteries themselves. Abbott Park, Ill.-based Abbott has received reports of battery swelling and overheating in the reader unit, but advised users that use of non-Abbott charging cables seems to drive the risk of such episodes, urging users to stick with the USB charging cables that came with the readers.
The U.S. FDA has wrapped up an October 2015 draft guidance for animal studies for medical devices, which prompted some lengthy responses from stakeholders concerned about some unique terms, such as device “handling.” Despite industrial opposition to the inclusion of that term, the final guidance retains the term handling and defines it in part as the manner in which the device “responds to the demands of the operator,” a term that may or may not be encompassed by the FDA’s overarching policy for human factors engineering.
The U.S. FDA has issued a guidance on when to file a new 510(k) for a class II device that has undergone significant modification, but that doesn’t mean everyone in the device business is paying attention. The FDA hit Synovo Production Inc., of Fullerton, Calif., for a number of violations of the Quality System Regulation (QSR), but also alleged that the manufacturer/specification developer made a number of modifications to its femoral resurfacing cup for hip implants without a new regulatory filing, leading the agency to direct the company to immediately cease production of the device.
The Biden administration has released the National Cancer Plan, a framework that expands and builds on the Cancer Moonshot program which came into being in 2016. The National Cancer Plan includes a strategies section that calls for development of new methods for detecting cancer and new imaging technologies for early cancer detection, just two provisions that would seem to portend good times ahead for companies that manufacture these products.
The U.S. FDA has been working for some time to develop less clunky regulatory mechanisms for digital health products, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health, has been touting a voluntary alternative pathway (VAP) as a modernized approach to premarket review.
The Advanced Medical Technology Association (Advamed) and the Biotechnology Innovation Organization (BIO) have teamed up on a friend-of-the-court brief for the U.S. Supreme Court’s upcoming hearing on twin cases that examine the question of a defendant’s state of mind when filing claims with federal health programs. Advamed and BIO argue that the existing judicial approach is critical to ensuring that companies in the life sciences are not subject to treble damages when acting reasonably in connection with products reimbursed by federal health programs, adding that an overturn of existing judicial practice would stifle innovation at the cost of patient access to life-saving medical therapies.
Developers of artificial intelligence (AI) and machine learning (ML) algorithms have found themselves returning repeatedly to the U.S. FDA for seemingly modest updates to their products, a problem that may soon be relieved by an FDA draft guidance on predetermined change control for AI and ML. However, Brad Thompson of Epstein, Becker & Green, P.C., told BioWorld that the terms of the draft “hugely increases the burden on developers to plan ahead” in order to obtain that postmarket relief from repeated 510(k) filings, a concession that device manufacturers and software developers may be more than willing to make.
Mergers and acquisitions in the U.S. have been under tremendous regulatory pressure over the past two years, a trend that seems likely to continue for the foreseeable future. However, Lina Khan, chairwoman of the U.S. Federal Trade Commission (FTC), said in a March 27 public forum that the agency will not wait for airtight cases to pursue legal remedies in part because the perfect case does not always arise, but also because the courts can be provoked into validating a novel legal theory even if the court does not ultimately side with the FTC.
A lot of eyes and ears were tuned to the U.S. Supreme Court’s March 27 argument in Amgen Inc. v. Sanofi SA with its focus on how much enablement is necessary in broad genus patent claims.
