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From an FDA regulatory history standpoint, it’s a major milestone. From clinical labs’ perspective it’s a power grab. For IVD firms, it’s a welcome, but incremental step. Ultimately, FDA’s lab-developed test rule, published April 29, could just end up being another waystation on the long-winding path to legislative reform.
By combining advances in AI and machine learning, image data extraction, and 3D printing, Carlsmed believes it can bring precision medicine to spine surgery. Investors supported the company’s strategy with a $52.5 million Series C.
The EU adds an extra round to its ongoing “scientific advice” pilot for high-risk devices. Excerpted from Pathways’ Picks April 2: EU Advice Pilot Extends, NTAP Watch, FDA Standards Scheme Starts Small.