Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has jumped on board the e-consent train for clinical trials, publishing a guidance for the use of electronic means for obtaining a study participant’s informed consent.
China’s recovery from its zero-COVID policy has failed to gain the momentum expected, with many experts predicting a slow or even negative growth rate. A slower economy, combined with a push toward self-reliance, bodes poorly for diagnostics manufacturers in the U.S. who may find themselves not just shut out of the huge market but facing stiffer competition around the globe. Further, policies designed to build a domestic next-generation sequencing industry have created headwinds for San Diego-based Illumina Inc. and others, noted Kyle Mikson and Alex Vukasin of Canaccord Genuity in an in-depth report.
Wearoptimo Pty. Ltd. saw the publication of a patent application for its method and system for analyzing measurements from a wearable patch with sensors connected to microstructures that when applied to the skin penetrate the stratum corneum and enter the viable epidermis.
People who can’t verbalize their pain often end up being under medicated, and Painchek Ltd. uses artificial intelligence (AI) to identify the presence of pain even when it may not be obvious. This gives a voice to those who cannot verbalize pain, while also driving objectivity and consistency in pain assessments.
When the data and safety monitoring board (DSMB) for Biocardia Inc.’s phase III pivotal trial of its Cardiamp cell therapy for heart failure advised pausing the study in July to analyze the interim results, the company expressed confusion as there were no reported treatment-emergent safety issues and aggregated blinded data showed better than expected outcomes. With the recommended external analysis now complete, the company confirmed the study is unlikely to achieve its primary endpoint at one year. The trial has now been unblinded.
Magassist Co. Ltd. has been granted a breakthrough device designation by the U.S. FDA for its interventional ventricular assist device (VAD), which is expected to accelerate the development and approval of the product.
A woman in Nambour, Australia, is the first patient to receive a minimally invasive implantable neuromodulation device for severe migraine and cluster headache in a first-in-human study conducted by Salvia Bioelectronics BV.
Researchers at the National University of Singapore (NUS) developed an aero-elastic pressure sensor to be applied to minimally invasive surgeries, aiming to address issues caused by existing pressure sensors.
India is taking steps to separate how it regulates medical devices and pharmaceuticals, as it works to reduce its dependency on imports of devices and turn itself into a global hub for med-tech innovation and manufacturing.
Two new sets of draft guidelines in China aim to strengthen and streamline registration systems while clearly spelling out additional rules for device makers to ensure quality management and controls, including strengthening controls over any outsourced manufacturing and calling of makers of implantable devices to manufacture in house.
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