Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Binx Health, Cerus Endovascular, Nines, Refine USA, Rheonix, Synaptive Medical.
Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Akarx, Alpha Cognition, Annovis Bio, Banner Life Sciences, Biocardia, Dova, Galectin, Genmab, Glaxosmithkline, Inmed, Junshi, Marker, Medivir, Neon, Pharming, Seelos, Zentalis.
Artificial intelligence-focused Chronolife SAS, of Paris, has secured class IIa medical certification from the EU for its smart T-shirt, which has the new brand name Keesense. The reusable, washable T-shirt is designed for comfortable, round-the-clock use. It works by transmitting data to a paired smartphone app via Bluetooth.
Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.
The FDA’s 15-day deadline for responses to warning letters has long been a sore spot for device makers, who might argue that some of the more complex regulatory findings require more than 15 days to analyze and address. That same timeline was found in both the draft and final versions of the non-binding feedback guidance for device inspections despite industry’s pleas that such a tight deadline leads to rushed judgment and potentially inadequate responses by managers at the manufacturing site.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diatherix, Medtronic, Photopharmics, Psychemedics, Senseonics, Vuno.
Six of six critically ill COVID-19 patients survived after being treated as compassionate care cases with Capricor Therapeutics Inc.’s lead candidate, an off-the-shelf cardiac cell therapy. The success prompted the FDA to review the data and approve the company’s expanded access protocol for treating as many as 20 more COVID-19 patients.
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