Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neocis, Nowdiagnostics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apogenix, Black Diamond, Chi-Med, Foresee, Hemoshear, Larimar, Momenta, Nabriva, Protara, Realta.
PARIS – Therapixel SA, of Nice, France, has obtained 510(k) clearance from the U.S. FDA for its Mammoscreen technology, a software platform based on artificial intelligence (AI) and used by radiologists for reading screening mammograms. “Obtaining FDA clearance is the result of working with radiologists over the past three years in order to develop a powerful tool providing relevant assistance in their day-to-day work,” Matthieu Leclerc-Chalvet, CEO of Therapixel, told BioWorld.
The U.S. FDA has rewritten the emergency use authorization (EUA) for the Laboratory Corp. of America Holdings Inc. (Labcorp) COVID-19 polymerase chain reaction (PCR) test to allow for diagnostic testing of those who are asymptomatic and those who have no reason to suspect they are infected with the SARS-CoV-2 virus.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Fortress Diagnostics, Lemaitre Vascular, MedPAC.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Color, Labcorp, Rapid Medical, Stratus Medical, Zebra Medical.
“Nothing to see here” seems to be the general reaction to the four executive orders President Donald Trump signed Friday in an effort to reduce U.S. prescription drug prices. Two of the orders – one on importing drugs from Canada and the other on kicking the safe harbor out from under the rebates pharmacy benefit managers (PBMs) get from drug companies – instruct Health and Human Services (HHS) to continue, or resume, rulemaking on those measures.
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