The question of bias in artificial intelligence (AI) algorithms is generally thought to be overcome by ensuring that the data set used to train the algorithm is representative of the population at large. However, Naomi Aaronson, executive director of clinical evaluation at the Blue Cross Blue Shield Association, said its not that simple because demographic data can combine in unpredictable ways and thus “the only real understanding of whether it works is in the clinical validation” of the algorithm in various settings.
With a 14% increase in regulatory news over this time last year, 2021 has proved to be the busiest that the biopharma industry has ever seen, as companies continue to seek clearances of their late-stage pipeline products with a backdrop of an unprecedented number of COVID-19 pandemic efforts.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Histosonics, Thermo Fisher Scientific.
The third time proved the charm for Adamis Pharmaceuticals Corp.’s high-dose naloxone injection, Zimhi, which gained FDA approval for use in treating opioid overdose, nearly three years after the San Diego-based company first submitted an NDA.
Omeros Corp.’s complete response letter (CRL) from the FDA regarding its BLA for narsoplimab did not come as much of a surprise to Wall Street, but still was enough to drive shares (NASDAQ:OMER) down 26.6% to close Oct. 18 at $5.67, a loss of $2.06.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Apellis, BMS, Chiesi, Gilead, Janssen, Lava, Merck, Pfizer, Rhythm, Sobi.
PERTH, Australia – Australia’s TGA issued new guidance to help device manufacturers better understand new classifications for active medical devices, including software-based medical devices, and clinical decision support software.
Feops SA reported that its Heartguide product has received de novo authorization from the FDA for pre-operative planning of left atrial appendage occlusion (LAAo) with the Boston Scientific Corp. Watchman device. The software platform is designed to help physicians virtually model clinical scenarios with different implant positions and sizes of the Watchman device using digital twin technology based on patient-specific virtual replicas of the heart. It is currently commercially available in the EU, U.K., Canada and Australia for transcatheter aortic valve implantation and LAAo workflows.
The FDA reported Oct. 14 that software used with the Alinity m test kit by Abbott Laboratories is being recalled for the potential for false positive results, a problem due to software used to automate the processing of the test. This recall was originally issued in mid-September, but the Abbott Park, Ill.-based company is advising labs to treat any test result as presumptive at best.
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