In this interview, Dr. Samir Shah, Chief Medical Officer at Qure.ai, shares why achieving FDA approval is crucial for their AI solutions and for fostering trust in the technology. Dr. Shah discusses how their…
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Breaking News: FDA’s Landmark Decision
The Food and Drug Administration (FDA) made a groundbreaking announcement on January 15, 2025, revoking the authorization of Red No. 3 in food products and ingested medications. This decisive action…
Women’s Health company Teal Health announced it garnered an additional $10 million in seed funding to support the launch of the Teal Wand, an at-home self-collect cervical cancer screening device, which is currently under…
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What You Should Know:
– Teal Health, a women’s health company dedicated to eliminating cervical cancer, announced today it has raised an additional $10M in seed funding led by Emerson Collective and Forerunner, with continued…
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Groundbreaking AI Healthcare Regulations Unveiled
The U.S. Food and Drug Administration (FDA) has initiated a transformative step in healthcare technology by releasing comprehensive draft guidance for AI-enabled medical devices on January 6, 2025. This pioneering…
Noam Solomon, CEO at Immunai
For over a decade, we’ve heard about AI’s transformative potential in therapeutics (Tx), but where’s the evidence? Has it all been hype? Can AI still revolutionize Tx? Or is there…
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French medtech startup Robeauté has raised $28 million (£23m) to develop its microrobots which enter the brain to diagnose, treat and monitor neurological conditions.
The robots, which are the size of a grain of rice,…
In November 2021, California-based virtual reality therapeutic company AppliedVR became the first medical extended reality (XR) company to be granted FDA De Novo clearance for a virtual reality healthcare product. AppliedVR’s RelieVRx (formerly EaseVRx) is…
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Breakthrough in Sleep Apnea Management
The FDA has marked a historic milestone by approving the first pharmaceutical treatment option for certain patients with obstructive sleep apnea. Dr. Sally Seymour, director of the FDA’s division of…
News
FDA issues draft guidance for supporting development and marketing of AI-enabled devices throughout the Total Product Life Cycle. It also publishes draft guidance for the use of AI to support development of drugs and…
