Friday, September 22, 2017
In healthcare, the speed of innovation is more critical than in other industries. Lives depend on it. So the FDAs recent decision to increase the pace of delivering new life-saving medical devices to market is a significant step.
[ Read More ]The FDA has officially kicked off a hiring process to fill more than a dozen positions within the agencys new digital health unit. The government’s job board lists two open positions for “interdisciplinary engineer” that will help develop and implement new policies for regulating innovative health devices.
[ Read More ]The Food and Drug Administration has issued final premarket guidance for how medical device manufacturers should address secure data exchange between devices and with other health IT systems.
[ Read More ]In a step that heralds a new era in cancer treatment, the US Food and Drug Administration (FDA) said on Wednesday it had approved a form of gene therapy that is highly effective at fighting an aggressive form of leukaemia in young patients with no other options.
[ Read More ]NxStage Medical, a company based in Lawrence, MA that focuses on hemodialysis equipment, won FDA clearance for its System One to be used by the patients at home and by themselves. This is the first such clearance that gives people with end stage renal disease a new level of independence from clinics and at-home carers.
[ Read More ]The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.
[ Read More ]Abbott received FDA approval for its HeartMate 3 left ventricular assist device (LVAD), a pump designed to augment cardiac output in patients with severe heart failure that are waiting for their heart to recover or that are in line for a transplant. Featuring the Full MagLev, as the technology is called by Abbott, the HeartMate
[ Read More ]The agency is instructing patients with certain implantable cardiac pacemakers from St. Jude Medical – now owned by Abbott Laboratories – to visit their physicians for firmware updates to address cyber vulnerabilities that can potentially be remotely exploited by hackers and that pose safety concerns.Approximately 465,000 such devices are in use in the U.S., an
[ Read More ]The U.S. Food and Drug Administration is getting tough on clinics marketing stem cell “therapies” that are unproven and potentially dangerous.
[ Read More ]TRENTON, N.J. (AP) The Food and Drug Administration has approved a new medicine for use against a rare, rapidly progressing blood cancer after other treatments have failed.The agency approved Pfizer Inc.’s Besponsa for patients with a type of advanced acute lymphoblastic leukemia. By then, life expectancy is low.”These patients have few treatments available and today’s
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