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Robotic surgery giant Intuitive Surgical reported higher-than-expected third-quarter revenues of $1.13bn, exceeding analyst's expectations. See what Wells Fargo's senior analyst, Larry Biegelsen, wrote about it here.
New Orleans-based UTC Laboratories agreed to pay $41.6m to resolve alleged violations of the False Claims Act, the US Department of Justice (DOJ) announced recently. See what CJ Porter, special agent in charge with the Department of Health and Human Service Office of the Inspector General, said about it here.
Johnson & Johnson's medical device businesses grew 5.3% on an organic basis in the third quarter led by the Bioscience Webster electrophysiology unit. See what Ashley McEvoy, Johnson & Johnson's worldwide chairman for medical devices, said during the earnings call here.
Abbott signed a deal with Tandem Diabetes Care to develop diabetes solutions combining Abbott's glucose-sensing technology with Tandem's insulin delivery systems. See what Tandem's CEO and president, John Sheridan, said about the partnership here.
At a recent industry meeting, US FDA recall officials emphasized that, contrary to what some device-makers may believe, there’s no requirement that recall documentation be submitted on paper, rather than electronically. See what Cecilia Wolyniak, the agency's recall team leader, said about it here.
Charlie Kim, president and CEO of software firm Soom, told Medtech Insight that he wanted to make a free app that provides safety and recall information for medical devices after his daughter almost died while being treated with a recalled device. See what he said about the experience here.
The Medical Device Manufacturers Association has advised the US Medicare agency to consult closely with orthopedic societies before finalizing a proposal to permit outpatient facilities and ambulatory surgery centers from performing knee and hip procedures. See what MDMA president and CEO Mark Leahey said about it here.
John Laschinger – a former US FDA cardiac devices medical officer who is now cardiac chief medical advisor for device-maker W.L. Gore & Associates – offered tips to manufacturers on how best to work with the agency. Check out his advice here.
Once upon a time, the US FDA's largest challenge around recalls communication was getting the word out about potentially dangerous products. But now a bigger risk is that recall notifications will be missed in a daily flood of communications, the agency's Doug Stearn says. Check out his comment here.
Elena Kyria, founder of UK-based recruitment firm Elemed, offers advice to people who are looking to change jobs within the medtech sector and are looking for regulatory opportunities. Check out her comments here.
Over the years, the US FDA's Jeff Shuren has proudly said that the agency's device center is the “gold standard” of global medical device regulations. But he now wants to move away from that concept. See what Shuren said here.
The US FDA is warning health-care providers and the medtech industry of serious vulnerabilities on certain operating systems used in medical devices that could allow malicious hackers to harm patients. See what the FDA's Suzanne Schwartz said about it here.
The US FDA will likely exercise enforcement discretion for device-makers when the agency rolls out its new rule that harmonizes the Quality System Regulation with international standard ISO 13485. See what Jeff Shuren, head of the agency's device center, said about it here.
Thomas Polen will take over as CEO of Becton Dickinson & Co. on 28 January 2020 when the current CEO, Vincent Forlenza, retires. See what Thomas Polen, who is the current COO of Becton Dickinson, said about it here.
Abbott Laboratories gained FDA approval for its low-dose, recharge-free Proclaim XR neurostimulator. See what pain specialist Jay Shah, CEO and executive medical director of the SamWell Institute for Pain Management said about it here.
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