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Florida-based medical device specification developer KL Distributing was handed a Form 483 for inadequate purchasing controls, training, medical device reporting (MDR) and other lapses.
Modulight’s ML6710i photodynamic laser for use with Bauch + Lomb’s Visudyne (verteporfin) for the treatment of age-related macular degeneration (AMD) may help fill an unmet medical need, the companies said.
Companies can find it challenging to figure out the most efficient and compliant method to bring new medical devices to the U.S. market. A thorough understanding of the nuances involved in FDA regulation of new devices is necessary for companies to successfully launch new products in the U.S. without regulatory complications. Both regulatory and business factors must be considered.
Penn Medicine cancer center in Philadelphia has performed the first ever patient treatment with Varian’s Halcyon and Ethos radiotherapy systems using the company’s HyperSight imaging technology.
The European Medicines Agency (EMA) is taking on a new role in monitoring and mitigating medical device shortages during public health emergencies, through a yet-to-be-created Medical Devices Shortages Steering Group (MDSSG).