The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several negative responses.

An artificial intelligence algorithm developed at Sheba Medical Center in Israel can identify patients at high risk of pulmonary embolism as soon as they walk through the hospital doors, a study published in the Journal of Medical Internet Research found. Using only information available from the patient’s medical history, the machine learning tool flagged high-risk patients before the initial clinical checkup occurred.

The U.S. FDA’s draft guidance for in vitro diagnostics under a Section 564 public health declaration broke little new conceptual ground, but the Association for Molecular Pathology (AMP) urged the agency to reconsider the COVID-19 experience.

In what represents the first patenting to emerge in the assignee’s name, additional protection is being sought for Rapidpulse Inc.’s aspiration system, which delivers high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy and remove thrombus from the neurovasculature.