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San Francisco-based digital health start-up Steady Health has launched the first "virtual" full-service diabetes clinic for patients in California. See what Henrik Berggren, CEO and founder of Steady Health, said about it here.
The rapid adoption of robotic-assisted surgery must be carefully monitored to ensure surgeons' enthusiasm for this technology does not compromise patient safety, according to a new study. See what Kyle Sheetz, a researcher at the University of Michigan who analyzed data from the Michigan Surgical Quality Collaborative, a partnership between Michigan hospitals and Blue Cross/Blue Shield of Michigan, said about it here.
Medtech Insight sat down with US FDA's principal deputy commissioner Amy Abernethy at the recent CES meeting in Las Vegas to talk about the agency's progress on the Technology Modernization Action Plan (TMAP), the pre-certification program for digital health products, and the FDA's plans for 2020. The FDA will hold a public meeting on 27 March to discuss the TMAP. See what FDA's Abernethy said about it here.
A panel of longtime industry experts recently convened to give manufacturers advise on the 10 best and 10 worst things they could do during an inspection by the US Food and Drug Administration. See what David Elder, executive VP of Greenleaf Health, said about it here.
Medtronic said it will acquire Stimgenics, which developed a differential target multiplexed spinal cord stimulation waveform, for an undisclosed figure. See what Marshall Stanton, who heads up Medtronic's pain therapy business, said about it here.
Draft legislation designed to make it easier for companies to gain patents for medical software is likely to make a comeback in the US Congress this year. Proponents of the bill say it will reverse a trend set by a six-year-old Supreme Court case that virtually made it impossible to get software patents. See what attorney Philip Nelson said about it here.
Illumina Inc. has agreed to pay $98m to terminate its merger agreement with Pacific Biosciences of California Inc. following opposition from antitrust regulators in the US and UK. See what Illumina CEO Francis deSouza said about it here.
University of California San Francisco physicians Rita Redberg and James Salazar share concerns about the state of medtech postmarket surveillance in the US in a recent editorial published by JAMA Internal Medicine. See what they wrote here.
French company Robocath expects its R-One robotic-assistance platform to make interventional cardiology more efficient and safer for interventionalists. See what company CEO Lucien Goffart said about “momentum in vascular robots” here.
Over the past year, next-generation sequencing (NGS) company Foundation Medicine has ramped up publishing research on genetic markers for cancer in peer-reviewed journals. Gaurav Singal, Foundation Medicine's chief data officer, says he’s particularly proud of the company's portfolio of solid tissue and liquid biopsy assays that complement each other to help diagnose and treat cancers. Check out his comment here.
ConMed's CFO Todd Garner told delegates at the Jefferies Healthcare conference that the company's orthopedic franchise is focused on its pipeline and meeting customer's needs. See what the CFO said about it here.
US congressional leaders and medtech industry advocacy group AdvaMed are giving their full-throated endorsement to a US-Mexico-Canada (USMCA) trade agreement announced by the US Trade Representative's Office on 10 December. See what AdvaMed's president and CEO, Scott Whitaker, said about it in a statement here.
Corindus Vascular Robotics Inc. expects its CorPath GRX robotic intervention system will eventually be part of a widespread system of "telerobotic" intervention sites operated by specialists located far away. See what Tejas Patel, an interventional cardiologist at the Apex Heart Institute in Ahmedabad, India, said about it here.
The global insulin pump market is expected to see significant growth, reaching $5.1bn by 2023. A new Market Intel story looks at the competitive landscape of the three leading companies in this market, Medtronic, Insulet and Tandem Diabetes Care, which are all expected to launch new products in 2020. See what Viral Shah, an assistant professor of medicine and pediatrics at the University of Colorado, said about the diabetes market here.
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.
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