Ad Hominis: FDA Authorizes Memic Innovative’s Surgical Robot
The device can conduct laparoscopic hysterectomies, giving surgeons more mobility while leaving less scarring.
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The International Consortium of Investigative Journalists started publishing the findings of its "Implant Files" investigation last month, but the two main industry groups in the US have not picked up any significant political backlash resulting from the reporting so far.
The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.