Philips launches BV family of C-arms:
This article was originally published in Clinica
Philips has launched its BV family of mobile C-arms, which are more manoeuvrable than its previous C-arm product line, and can be used in a range of applications. The BV Libra is intended for routine surgery, the BV Endura is designed for vascular imaging, and the BV Pulsera is targeted at lengthy, more complicated interventional procedures. The Pulsera can also be used outside the operating room as an economic cardiovascular imaging system, because it is four to five times cheaper than dedicated, fixed room systems, according to Philips.
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.