The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) is among the regulators across the globe that are scrambling to keep pace with artificial intelligence (AI) in medical devices, releasing an April 30, 2024, paper on its own approach. One of the key considerations in this paper is that MHRA expects to up-classify some AI-enabled device software functions in its ongoing regulatory revamp, a prediction that suggests a more stringent premarket path for these products in the years ahead.
Recent advances in artificial intelligence (AI) have generated a tsunami of popular dystopian musings, but the U.S. Patent and Trademark Office (PTO) has its own concerns about AI’s impact on intellectual property. PTO recently announced that it is looking for feedback on the use of AI to produce what litigants might spuriously claim is prior art, a concern that must be addressed if the patent system is to avoid crashing under the weight of an unmanageable volume of AI-generated clutter.
In what represents its first patenting, PBSF Inc. filed for protection of brain monitoring and neuroprotection strategies for infants at high risk on a large scale.
Lund, Sweden based-Paindrainer AB received notification from the European Patent Office that it intends to grant this patent application for its digital tool, Paindrainer, which coaches users in managing their pain and provides guidance on how to reach a personalized activity balance to reach an optimal functional level and alleviate pain.
In what represents just the third PCT filing to have been published in the name of Zurich, Switzerland-based Siva Health AG, protection is sought for a computer-implemented method of classifying an individual suffering from chronic cough.
In one of the biggest startups ever, Xaira Therapeutics has launched with more than $1 billion from investors. The financing, according to BioWorld records, is roughly equivalent to Roivant Sciences Inc.’s $1.1 billion raise in August 2017 and Galderma Inc.’s $1 billion private placement in June 2023. Xaira said it plans to leverage advanced machine learning research and expansive data generation to power new models for developing new therapeutics.
In one of the biggest startups ever, Xaira Therapeutics has launched with more than $1 billion from investors. The financing, according to BioWorld records, is roughly equivalent to Roivant Sciences Inc.’s $1.1 billion raise in August 2017 and Galderma Inc.’s $1 billion private placement in June 2023.
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.
A computational program based on single-cell transcriptome sequencing has identified six types of senescent cells, enabling the design of more precise senolytic drugs. The success of these compounds depends on their ability to recognize senescent cellular patterns and avoid proliferating cells, differentiated cells, or quiescent (temporarily resting) cells.
One of the problems with the European Union’s Artificial Intelligence Act is that it spans all sectors of the E.U. economy, an approach that Sen. Bill Cassidy (R-La.) suggested is less than optimal in remarks to this year’s meeting of the Medical Device Manufacturers Association. Nonetheless, Cassidy said some in the Senate are keen to pass legislation without taking proper stock of the lack of congressional expertise, which runs the risk that hasty legislation may create more problems than it solves.
