The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several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The U.S. FDA’s draft guidance for in vitro diagnostics under a Section 564 public health declaration broke little new conceptual ground, but the Association for Molecular Pathology (AMP)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.
Speculation about potentially wider meaning among developers of psychedelic drugs was reignited after the complete response letter (CRL) from the U.S. FDA to Lykos Therapeutics Inc. for midomafetaminecapsules, which the company wants to use in combination with psychological intervention to treat post-traumatic stress disorder (PTSD). CEO Amy Emerson called the FDA move “deeply disappointing,” adding that San Jose, Calif.-based Lykos plans to request a meeting with the FDA to ask for reconsideration.
Concerns of lower-than-expected efficacy, which prompted AN2 Therapeutics Inc. to pause enrollment in the phase III portion of the phase II/III trial earlier this year, turned out to be well-founded, as top-line data proved disappointing for epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease. As a result, the company is dropping the program and restructuring.
Aldeyra Therapeutics Inc. has bounced back from a complete response letter in November to produce positive phase III data for reproxalap in treating dry eye disease. The company is one of many developing treatments using diverse mechanisms of action.
Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Angelman syndrome, with improvements seen in clinically important aspects of the disease, including communication, behavior, cognition and motor abilities, Neuren CEO Jon Pilcher said during an Aug. 9 conference call.
Minneapolis-based Smiths Medical Inc., recalled two entries in the company’s CADD-Solis line of ambulatory infusion pumps due to problems with the preloaded software.
Nevro Corp. retained advisors to explore strategic alternatives, including a possible sale of the business or acquisitions that could shift its focus to earlier points in the pain management process. The spinal cord stimulator company faces increased competition in its core market.
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