Just six weeks after receiving FDA 510(k) clearance for its optical coherence tomography (OCT) imaging system (v2.1), Perimeter Medical Imaging AI Inc. received breakthrough device designation from the FDA for its next-gen product, the OCT imaging system with integrated artificial intelligence (AI).
HONG KONG – Beijing Stonewise Technology Co. Ltd., a med-tech firm that uses artificial intelligence (AI) to aid in the discovery of small molecule drugs, closed series B and B+ financing rounds that added $100 million to its pocket. The company intends to use the proceeds to upgrade its AI-enabled drug discovery platform.
Microsoft Corp. will purchase Nuance Communications Inc. for $19.7 billion in cash in a move that demonstrates a massive commitment to building out the Microsoft Cloud for Healthcare reported in late 2020. The acquisition, which is expected to close by the end of 2021, doubles the Redmond, Wash.-based company’s total addressable market in the health care provider space, bringing it to nearly $500 billion. The size of the transaction is notable even for a company with the active acquisition history of Microsoft.
Cosmo Artificial Intelligence Ltd. received the FDA’s nod for its GI Genius intelligent endoscopy system. The device – the first of its kind, according to the agency – uses artificial intelligence (AI)-based on machine learning to improve the detection of lesions during colonoscopy. It will be rolled out in the U.S. by Medtronic plc, which has exclusive worldwide distribution rights.
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. 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.
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.
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.
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