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).
Anyone who has had a malignant tumor removed knows the anxiety that follows. Did any traces of cancer remain, and if it returns, will doctors catch it before it’s too late? To reduce the uncertainty and improve patient outcomes, C2i Genomics Inc. has raised a $100 million series B funding round led by Casdin Capital to advance software that is 100 times more sensitive in detecting residual disease than legacy technologies.
The Biden administration’s fiscal 2022 budget proposal included an allocation for an office described as the Advanced Research Projects Agency – Health, or ARPA-H, which would receive $6.5 billion as part of the National Institutes of Health.
TORONTO – For Scott Kadwell, president of Markham, Ontario-based RSK Medical Inc., the distributor tagged to sell the Health Canada approved Gammacore Sapphire, the device represents “a shift from a business to business to a direct-to-consumer business model.” For Rockaway, N.J.’s Electrocore Inc. which developed the self-administered technology, it’s one more regulator to have greenlighted the FDA cleared, CE-marked device for treating intractable migraine and cluster headache.
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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reverses HHS premarket notification exemptions; ITC will check findings for Zimmer/Heraeus dispute.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perimeter Medical Imaging AI.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Castle Biosciences, Gynesonics, Nanoview Biosciences.
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