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Regulatory
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PMD 200 platform in operating room

Medasense gets FDA nod for its nociception technology

Feb. 23, 2023
By Annette Boyle
Medasense Biometrics Ltd. received U.S. FDA marketing authorization for its PMD-200 patient monitor with nociception level index (NOL) technology that monitors patients’ physiological response to pain during surgery. NOL uses a multi-parametric sensor platform combined with artificial intelligence (AI) algorithms to generate a ‘signature of pain’ for patients under anesthesia who are also receiving opioids and other analgesics.
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US CMS refuses to budge on coverage of Alzheimer’s drugs

Feb. 23, 2023
By Mari Serebrov
Despite pleas from patient advocacy groups and bipartisan pressure from the U.S. Congress, the Centers for Medicare & Medicaid Services (CMS) isn’t budging on its national coverage determination for amyloid-targeting monoclonal antibodies approved to treat Alzheimer’s.
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Regulatory actions for Feb. 23, 2023

Feb. 23, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Innovation Zed, Medasense Biometrics, Mologic, Remidio.
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Regulatory actions for Feb. 23, 2023

Feb. 23, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Alimera, Cognition, Erydel, Fapon, GSK, Pfizer, PTC, Sage, Seagen, Viiv, Vir.
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Product recall concept image

GE Healthcare recall for imaging systems addresses potentially fatal detector collapse

Feb. 22, 2023
By Mark McCarty
GE Healthcare Technologies Inc. reported a recall of several systems in its nuclear medicine line of high-end imaging systems for two potential issues that could lead to the collapse of a detector weighing more than half a ton onto the patient. According to the U.S. FDA listing for the recall, no injuries or fatalities have been reported in connection with these issues, but the announcement resurrects an episode from 2013 in which a patient in New York lost his life when a nuclear imaging camera collapsed during an imaging procedure.
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US ITC’s exclusion order favors Alivecor over Apple, but order held pending appeal of IPR

Feb. 22, 2023
By Mark McCarty
Alivecor Inc. has nudged the U.S. International Trade Commission (ITC) into issuing a limited exclusion order for products by Apple Inc. that are said to violate patents held by Alivecor, but there is one more stage gate to go for Alivecor. The ITC order notes that the exclusion won’t go into force until resolution of an inter partes review (IPR) involving the two firms, a process that could devour as much as a year and a half before a resolution is available.
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UK begins review of what’s needed to revive clinical trial scene

Feb. 22, 2023
By Mari Serebrov
Looking to turn around the decline of clinical trials within its borders, the U.K. government appointed James O’Shaughnessy, a former health minister, board member of Health Data Research UK and a senior partner at Newmarket Strategy, to conduct an independent review of the country’s commercial clinical trial landscape.
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Regulatory actions for Feb. 22, 2023

Feb. 22, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rapidai, Spectrum Solutions.
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Regulatory actions for Feb. 22, 2023

Feb. 22, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Akebia, Alnylam, Arcutis, Azafaros, Beckley, Biohaven, Biosyngen, Chemomab, Cincor, GC, Icosavax, Kadimastem, Mezzion, Optinose, Orasis, Pfizer, Regeneron, RVAC, Sinovac, Valneva, Vaxcyte.
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US FDA’s final amended rule for radiological products in force

Feb. 21, 2023
By Mark McCarty
The U.S. FDA recently proposed a modest overhaul of the rules pertaining to radiological products and other categories of products in an effort to eliminate duplicative or obsolete rules, such as a requirement for triplicate reports for variances in system performance.
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