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Clinical / R & D
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Breathing Easy: ALung CEO Talks Novel Hemolung Device, FDA's Breakthrough Pathway, Landmark US/UK Clinical Trials
In a deep-dive sit-down interview with Medtech Insight, ALung Technologies CEO Pete DeComo dishes on US FDA's Breakthrough Devices Program and explains why his firm's novel artificial lung device, Hemolung, is worthy of traveling the expedited pathway to agency approval. DeComo also details two pivotal Hemolung clinical trials in the US and UK, and explains why Hemolung isn't marketing the device for commercial use despite being approved in 36 countries outside the US. He also talks about a future portable version of Hemolung, but noted that's not where ALung is focused right now. "Our first task is that first-generation technology – to get it to market, make it the standard-of-care, and then, if you are successful with all of that, you can do all of those wonderful other things as it relates to portability and wearability," DeComo says.
Clinical Trials
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Latest From Clinical Trials
Results Recap: Trial Results Presented At ObesityWeek, AHA, And Veith Meetings
Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition, covering the week of Nov. 9 - Nov. 15, includes trial data presented at the Veith symposium Nov. 13 - 17 in New York, the American Heart Association Scientific Sessions in Chicago Nov. 10 - 12, and the ObesityWeek meeting in Nashville Nov. 11 - 15.
QUOTED. Nov. 16, 2018. Scott Gottlieb.
US FDA is proposing to amend its regulations to allow an institutional review board to waive or alter informed consent when a clinical investigation "poses no more than minimal risk" to human subjects and includes safeguards to protect their rights and safety. See what agency head Scott Gottlieb said about it here.
Device Week, Nov. 15, 2018 – Digital Solutions Of The Future, And Clinical Trial News And Insights
On this week’s podcast, Reed Miller talks to Medtech Insight’s managing editor Marion Webb about digital health technologies of the future, showcased at the Exponential Medicine conference in San Diego, featured in depth in the latest Market Intelligence story. Medtech Insight’s deputy editor Reed Miller introduces Medtech Insight’s new “Tracking Trials” section, which features a list of trials that are starting, ending or finishing enrollment; including the “Results Recap,” a summary of trials that announced results. He also gives an update of key clinical trial news from this week’s American Heart Association meeting in Chicago.
New Technology
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Latest From Innovation
Latest Sapien Valve Gets EU Go-Ahead, But Germany Will Have To Wait
Edwards Lifesciences plans a "controlled rollout" of its Sapien 3 Ultra transcatheter heart valve replacement in Europe following the CE mark announced Nov. 16. But a patent dispute with Boston Scientific will prevent Edwards from launching it in Germany.
Device Week, Nov. 15, 2018 – Digital Solutions Of The Future, And Clinical Trial News And Insights
On this week’s podcast, Reed Miller talks to Medtech Insight’s managing editor Marion Webb about digital health technologies of the future, showcased at the Exponential Medicine conference in San Diego, featured in depth in the latest Market Intelligence story. Medtech Insight’s deputy editor Reed Miller introduces Medtech Insight’s new “Tracking Trials” section, which features a list of trials that are starting, ending or finishing enrollment; including the “Results Recap,” a summary of trials that announced results. He also gives an update of key clinical trial news from this week’s American Heart Association meeting in Chicago.
QUOTED. Nov. 14, 2018. Matteo Lai.
Matteo Lai, CEO of a company that makes the first US FDA-cleared seizure-monitoring smart watch, says users don't care much about artificial intelligence or fancy technology. Rather, they simply want the device to be easy to use and to do its job. See what Lai said about it here.
Approvals
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Latest From Approvals
Latest Sapien Valve Gets EU Go-Ahead, But Germany Will Have To Wait
Edwards Lifesciences plans a "controlled rollout" of its Sapien 3 Ultra transcatheter heart valve replacement in Europe following the CE mark announced Nov. 16. But a patent dispute with Boston Scientific will prevent Edwards from launching it in Germany.
Global Device Approvals, Weekly Snapshot: Pelvic Floor Strengthener, Peripheral Stent
A snapshot of medical device approvals captured in Medtech Insight's Approvals Tracker. A muscle stimulation device to treat urinary incontinence passed US FDA's review, while a peripheral artery stent with a new delivery system gained European sign off.
Special 510(k) Pilot Includes All Qualifying Submissions, FDA Says
US FDA officials clarified how devices can qualify for an ongoing special 510(k) pilot program during a Nov. 8 online seminar.
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