The North American Spine Society Annual Meeting provided a positive view of one area in orthopedics that may be immune from the effects of widespread use of GLP-1 medications. Recent data indicates volumes and seasonality have finally recovered from pandemic impacts. Major trends discussed at the conference included expanded use of robotic systems, increased customization and adoption of augmented reality technology.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.
For individuals who develop an unexpected psychosis, there is something to be said for testing them for autoimmune antibodies. And something against. At the 36th Congress of the European College of Neuropsychopharmacology (ECNP) this week, the topic was worth a controversy session, where speakers presented the pros and cons of the approach. Currently used tests have a specificity of 99%. But as Ester Coutinho, consultant neurologist at the University of Coimbra, pointed out, the validity of diagnostic tests depends on the prevalence of the disorder one is looking for as well. Coutinho estimated that autoimmune psychoses account for 1% of psychoses overall.
Unlocking the future of drug development often means removing obstacles that currently stand in the way. Reimbursement is one of those obstacles, as is keeping humans deeply involved as innovators and patients even as artificial intelligence (AI) increases its role. A panel of developers spoke about what they anticipate will be the biggest changes in the coming 10 to 20 years at the BioFuture 2023 conference in New York on Oct. 5. A common theme was reforming the structure of reimbursements, which has traditionally been a problem in the digital therapeutic realm, according to Eric Elenko, chief innovation and strategy officer at Puretech Health plc.
Springboarding off the success of its AI-based imaging software for cancer detection, the deep learning-based artificial intelligence (AI) company Lunit Inc. has another AI software, called the Lunit Scope, up its sleeve for which it hopes to gain U.S. FDA approval by 2025.
“Change is the only constant” is an ageless truth. In the search for age-related biomarkers, it is also a prosaic confounding factor.
Age-related biomarkers will be critical for the development of antiaging therapeutics. “Nobody is planning to do a life span study in humans,” Eric Verdin told the audience at the 10th Conference on Aging Research and Drug Development in Copenhagen on Monday. “Hence the need for … surrogate markers.”
Artificial intelligence (AI) continues to entice. On the exhibition floor at the 2023 Congress of the European Academy of Neurology, one company’s booth featured “Mindart” technology. A passersby could answer a short series of prompts, and get a unique image based on the input made by generative AI. Entertainment aside, medically speaking, AI applications “are still research,” Riccardo Soffietti told his audience at one of several sessions devoted to AI. “But obviously, research is the future.”
Artificial intelligence (AI) faces a number of interesting hurdles in the EU, such as the still-developing Artificial Intelligence Act (AI Act), which seems destined to treat health care uses as high-risk propositions. Corinne Dive-Reclus, director of global lab insights at Roche Diagnostics, said there are possible solutions, such as overwriting the AI Act’s risk classifications with the risk category provided by existing regulations, but there is an open question as to whether a fix will be in place to prevent a potentially disastrous risk framework for AI in health care.
Breakthroughs in early detection of cancer offer increasing hope for better outcomes and longer lives for individuals affected by malignancies. This year’s American Society of Clinical Oncology annual meeting highlighted strong results from several companies at the forefront of this potential transformation.