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Investors are backing imaging diagnostics company Magnetic Insight Inc. with $17 million to develop its magnetic particle imaging (MPI) technology. The clinical imaging application consists of two core technologies: hardware and a tracer that, together, produce 3D images of how a patient’s body works. Venture firm Celesta Capital led the series B round with Alumni Ventures Group, Gaingels and existing investors 5AM Ventures and Sand Hill Angels participating.
Artificial intelligence (AI) and machine learning (ML) are all the rage in 2022 when it comes to medical radiology, but regulators across the globe are struggling to devise regulatory frameworks that ensure safety and efficacy without strangling innovation. There are a number of other stakeholders in this sphere of med tech, however, each with their own considerations. In this six-part series, BioWorld will examine these considerations in an effort to characterize the working environment for AI and ML as it exists now, and what that environment might look like in the years ahead.
Detecting the spread of cancer is a high priority for most health systems, but the U.K. National Health Service currently has a limited range of options when it comes to detecting breast metastases. That may change soon thanks to a review by the National Institute of Health and Care Excellence (NICE), which may endorse the use of the Sentimag system with Magtrace.
Beacon Biosignals Inc. has teamed up with Stratus Inc., a provider of electroencephalogram (EEG) services, to improve at-home brain monitoring and neurodiagnostics using Beacon’s machine learning-driven neuroanalytics platform. The collaboration will increase opportunities for home-based studies of Alzheimer’s and other neurological diseases.
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
The Spanish National Research Council, CSIC, has just been awarded funding from the European Research Council to establish proof of concept for new type of flat-plate positron emission tomography scanner (PET) that can be attached to the patient’s body to accurately monitor cancer proton therapy results in real time.
Perkinelmer Inc. said the Vega is a first-of-its-kind preclinical ultrasound system that will accelerate preclinical research and drug development studies of cancer, cardiovascular, liver, kidney and other diseases. The imaging platform combines hands-free automation with high-throughput capability, which the company said is a major advance over manual ultrasound scanning across the bodies of individual lab mice.
Semiconductors chips, a key component in many medical devices, continue to be in short supply as COVID-19-driven supply chain disruptions continue. The shortage comes at the worst possible time, with demand for the chips on an upward trend. Nano-x Imaging Ltd.’s (Nanox) solution to the shortage was to open a semiconductor chip fabrication plant in Yongin, South Korea, to produce Nanox.source, a semiconductor chip that replaces the filament in the analog X-ray tube.
Clinicians are still at liberty to use medical products outside the labeled indication for use, but the U.S. FDA believes radiologists may be unaware of the limitations of radiological computer-aided triage and notification (CADt) software for intracranial large-vessel occlusion (LVOs). The agency advised clinicians that these programs are not intended for use as a substitute for radiologist review of images, but instead should be used only to flag suspect images as part of an effort to triage these patients.
The U.S. CMS has suspended the effective date of the radiation oncology (RO) model for bundled care under the Medicare outpatient prospective payment system. The development stems from congressional legislation that pushed the start date back until next year, giving stakeholders who are opposed to the program more time to press their case with Congress and the agency.