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Spencer Hutchins, whose company Reflexion Health's rehabilitation gaming software Vera was recently cleared by FDA says companies like his often have the engineering chops to build medical device software but not the regulatory know-how.
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Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.
The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.