The authors of a recent journal article see problems with the FDA’s approach to premarket review of artificial intelligence (AI) algorithms, including an undue reliance on single-site algorithm development. Regulatory attorney Brad Thompson told BioWorld, however, that hospital administrators want algorithms that maximize accuracy for their populations and are not averse to in-house development of just such an algorithm, thus creating a source of tension between what hospitals want and what the FDA expects.
COVID-19 has caused a surge in telemedicine, increasing access to health care without having to physically visit a doctor. In similar ways, it is changing things in the operating room, where advanced technology platforms enable surgeons and specialists to observe or weigh in on surgeries and allow manufacturer reps to assist in procedures using new devices.
HONG KONG – Coreline Soft Co. Ltd. has taken its first step into the Greater China market after receiving approval from Taiwan’s Food and Drug Administration (TFDA) on April 8 for its Aview suite of artificial intelligence (AI) medical solutions.
Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology.
Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology. The company’s goal is to take the medical devices that have been used most ubiquitously throughout medicine, one by one, and replace them with smart technologies that incorporate such things as software, sensors and signals technologies.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acarix, Akili Interactive, Boston Scientific, Cardiac Dimensions, Lumithera, Medcura, Pixium Vision, Protokinetix.
Vysioneer Inc. has won the FDA’s nod for its Vbrain artificial intelligence (AI)-powered tumor autocontouring software. The company said Vbrain is the first AI device to receive FDA clearance for tumor autocontouring in radiation therapy. Vbrain is a neural network-based AI solution, trained from clinical data.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips, Roche.
TORONTO – Robotics researchers at Ontario’s University of Waterloo are stealing a page from makers of autonomous or self-driving vehicles, developing wearable, motor-controlled technology to restore physical mobility in people with disabilities without the need to think about or guide the system. The project, called Exonet, is being led by Brokoslaw Laschowski, who contrasts this approach with engineers ramping up the ability of users to control the exoskeleton.
TORONTO – “There’s no magic pill that helps patients with concussion except physical activity,” Ashleigh Kennedy, CEO of Neurovine Inc. told BioWorld. But how does a patient in rehab know when to put on the brakes if they’re working too hard physically or mentally?
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