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A draft guidance document by the US FDA that tackles medical device cybersecurity will likely be issued in the next several months, says Linda Ricci, a health scientist for the agency’s Office of Device Evaluation. Check out her comments on cybersecurity here.
Medical device regulations that were set in place by the US FDA in the 1990s are evolving with the emergence of digital-health products and their iterative nature, medtech consultant Jon Speer says. Check out his comment here.
Device maker Avatera Medical is preparing to launch a new surgical robot system on the market in 2020. See why company CFO Oliver Kupka calls the system the “German Robot” here.
Medical device manufacturers that build bridges with US FDA investigators will have an easier go of things during facility inspections, ex-agency official Ricki Chase says. By doing this, firms can extend that trust to the agency as a whole. Check out her comments here.
While a lot of medtech companies are working on developing artificial intelligence and machine learning products, the technology is moving far faster than regulators can keep up. One self-proclaimed “standards nerd,” however, has taken it upon himself to aggregate already recognized AI/ML standards to try stay up-to-date with the technology. See what Philips Healthcare’s Pat Baird said here.
Mountain View, CA-based AliveCor, which received US FDA clearance for its KardiaMobile 6L six-lead ECG device, was among the innovative companies presenting at the Exponential Medicine conference in San Diego. See what Suraj Kapa, a professor at the Mayo Clinic, said about it here.
The health-care sector remains ripe for investments, according to an expert panel of private equity investors. See what Steve Dyson, partner at UK private equity firm Apax Partners, said about it during a panel discussion at the recent Jefferies Healthcare Conference in London.
Tusker Medical won US FDA approval for its Tubes Under Local Anesthesia (Tula) System, the first device allowing ear tubes to treat recurrent ear infections in children to be installed in the physician's office under local anesthesia. See what Jeff Shuren, director of the agency's device center, said about it here.
LimFlow expects the US Food and Drug Administration to approve its percutaneous deep vein arterialization system for patients with advanced critical limb ischemia by the end of 2021. See what Lim Flow's CEO, Dan Rose, said about it here.
Court rulings related to the False Claims Act (FCA) this year focused on whistleblower rules and further clarifying the theory of liability given in the Supreme Court's 2016 Escobar decision. Device manufacturers, however, should also be aware of the FDA's ongoing focus on the opioid epidemic. See what Jonathan Phillips, an attorney with Gibson Dunn, said about it here.
The US Senate has settled with the House on another continuing resolution maintaining a 2019 funding level for the FDA and other agencies through 20 December. The Trump administration appears eager to avoid a repeat of last year’s negotiations, which led to a federal shutdown. See what Steven Grossman with the Alliance for a Stronger FDA said about the chances of the government shutting down again this year.
The US FDA has approved CooperVision Inc.’s MiSight, the first contact lens that can help slow the progression of nearsightedness (myopia) in children. See what CooperVision president Daniel McBride said about it here.
Device manufacturers often fall down when conducting process validation activities because they fail to continually monitor their processes, consultant and former FDA investigations branch director Ricki Chase says. See her comments here.
The US FDA has cleared the Pentax Medical Video ED34-i10T2, the first duodenoscope for the US market with a sterile, disposable elevator component designed to reduce the number of parts that need to be disinfected between uses. See what Jeff Shuren, director of the agency’s device center, said about it here.
Cardiawave's non-invasive ultrasound therapy is feasible and safe in patients with severe symptomatic aortic stenosis, according to early trial results presented at the annual American Heart Association meeting. See what Cardiawave's CEO, Benjamin Bertrand, said about it here.
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