Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods….
Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods….
…and training new FDA investigators; $5 million in funding has been requested to go towards a strategy for new and alternative methods for product testing in an effort to reduce…
…and training new FDA investigators; $5 million in funding has been requested to go towards a strategy for new and alternative methods for product testing in an effort to reduce…
…the possibility of a whole new set of opportunities. The pandemic was a catalyst for exploring alternate care settings, for example using remote monitoring with smart devices combined with televisits…
…the possibility of a whole new set of opportunities. The pandemic was a catalyst for exploring alternate care settings, for example using remote monitoring with smart devices combined with televisits…
…on the Preliminary Regulatory Impact Analysis for this proposed rule, the FDA estimated that there are approximately 4,445 companies that do not currently comply with ISO 13485. To those companies,…
…on the Preliminary Regulatory Impact Analysis for this proposed rule, the FDA estimated that there are approximately 4,445 companies that do not currently comply with ISO 13485. To those companies,…
…the company stated, “It is not necessary to remove affected Philips V60/V60 Plus ventilators from service.” Thus far there have been no reports of injuries, adverse events or patient deaths…
…the company stated, “It is not necessary to remove affected Philips V60/V60 Plus ventilators from service.” Thus far there have been no reports of injuries, adverse events or patient deaths…
…not going away anytime soon and will continue to grow as new compliance challenges arise. It’s never too late to take the leap into this new digital age. There are…
…not going away anytime soon and will continue to grow as new compliance challenges arise. It’s never too late to take the leap into this new digital age. There are…
…devices have become a prominent part of daily life, and most notably for patients who are managing chronic conditions. Although commercial devices such as the Fitbit or Apple Watch are…
…devices have become a prominent part of daily life, and most notably for patients who are managing chronic conditions. Although commercial devices such as the Fitbit or Apple Watch are…
…but now is connected may no longer be supported or technologically costly or infeasible to remediate, too. In cases when a patch is unavailable, some type of compensating control must…
…but now is connected may no longer be supported or technologically costly or infeasible to remediate, too. In cases when a patch is unavailable, some type of compensating control must…
…has shifted to set the stage for a new paradigm in therapy advancement: Personalized care. There is significant opportunity to develop therapies that create new standards of care and initiate…
…has shifted to set the stage for a new paradigm in therapy advancement: Personalized care. There is significant opportunity to develop therapies that create new standards of care and initiate…
Yesterday the FDA issued an alert to medical device users and manufacturers about a cybersecurity vulnerability in software components that could allow an unauthorized attacker to gain complete system access…
Yesterday the FDA issued an alert to medical device users and manufacturers about a cybersecurity vulnerability in software components that could allow an unauthorized attacker to gain complete system access…
