Japan has long been one of the premier markets for medical technology, but this market has suffered from a reputation for slow adoption of technologies outside the cardiovascular device space, a problem the Pharmaceuticals and Medical Devices Agency is keen to address.

Patent litigation doesn’t always create outlandish damages awards but when it does, the outlandishness typically trends toward inordinately large sums. This was decidedly not the case in the Federal Circuit hearing in a patent lawsuit pitting Intuitive Surgical Inc., of Sunnyvale, Calif., against Rex Medical LP, of Conshohocken, Pa., given the damages awarded to Rex amounted to a mere $1.

John Squires, the recently anointed director of the U.S. Patent and Trademark Office, has determined that a machine learning patent application met the standard for patent subject matter eligibility, an outcome that seems to bode well for ML-based patent applications going forward.

Digital mental health tools are popping up with some regularity lately, but both Australia’s Therapeutic Goods Administration and the U.S. FDA have enough concerns about these products that they are taking a closer look at their risks and benefits.

The budget impasse between Democrats and Republicans on Capitol Hill has implications for a wide range of federal government operations, including at the U.S. FDA, which is absorbing another round of layoffs and cannot accept new premarket filings that require user fee submissions.

John Squires, the recently anointed director of the U.S. Patent and Trademark Office, has determined that a machine learning (ML) patent application met the standard for patent subject matter eligibility, an outcome that seems to bode well for ML-based patent applications going forward.

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) reported that it will seek to deepen its collaboration with other regulators, a list that includes but is not limited to the FDA. MHRA said that the U.K.-U.S. reliance program would apply to not only class II devices under the 510(k) and de novo programs, but to class III PMA devices as well, promising a somewhat more streamlined path to a market ripe with opportunity for the devices and diagnostics industries.

The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans for software as a medical device. The problem for advocates of regulatory harmonization is that the IMDRF draft overlaps awkwardly with the FDA’s approach, which has issued separate policies for the AI subset of device software functions and a separate guidance for all other devices, including non-AI software.

The U.S. FDA device center’s guidance agenda for fiscal 2026 is the classic case of something old and something new, but what was borrowed from FY 2025 may make some blue.

The U.K. Medicines and Healthcare Products Regulatory Agency has decided to lean into personalized medicine with the adoption of the concept of a “preference zone” for determining when a therapy can and cannot be used for a specific patient, a concept that is liable to lead to more demanding postmarket surveillance.