The U.S. FDA posted notice of a recall of the system monitor for the Heartmate left ventricular assist device by Abbott Laboratories, an action necessitated by reports of a series of malfunctions that may lead to inadvertent operator error.
After snaring the U.S. FDA’s approval for the Evoque tricuspid valve device, Edwards Lifesciences Corp. petitioned the Centers for Medicare & Medicaid Services for a national coverage determination for transcatheter tricuspid valve replacement devices.
In a ruling delivered June 28, the U.S. Supreme Court brought an end to four decades of a practice of judicial deference to federal government agencies in litigation under the Chevron doctrine, a practice that some argue has enabled regulatory mischief.
A trio of regulators devised a series of good machine learning practices in 2021, a key point of consideration for many algorithms that will eventually be used in thousands of medical applications in the coming years.
The device industry has been clamoring for legislation that would require Medicare coverage for FDA-designated breakthrough devices, a wish that is one step closer to fulfillment as of June 27.
The U.S. FDA reissued a 2022 draft guidance for clinical trial diversity at the behest of legislation from Congress, ballooning the previous nine-page draft to 23 pages.
The problems with devices for low-volume conditions are well known, and regulatory agencies such as the European Union’s Medical Device Coordination Group are working to ease the regulatory hurdles for these products.
Sometimes a court cites long-standing precedent in deciding how to handle a case, but the U.S. Court of Appeals for the Federal Circuit leveraged a decision it rendered only last year in deciding a patent case between Apple Inc., and Omni Medsci Inc.
Medicare spending in the U.S. continues to climb at a worrying pace, given that policymakers are apt to respond by putting the squeeze on the doctors and hospitals that purchase and implant medical devices.
The trade secret dispute between Acton, Mass.-based Insulet Corp. and Eoflow Co. Ltd., of Seongnam, South Korea, addresses several key questions in the area of intellectual property law, including the circumstances in which injunctive relief is and is not appropriate.
