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Less-invasive technologies to treat benign prostatic hyperplasia are fast becoming viable alternatives to medication and surgery. Here's what one researcher in the area, Steven Raman, had to say about the new options.
The US FDA has abandoned all near-term plans to inspect Chinese manufacturing facilities in the wake of the coronavirus crisis. See what agency head Stephen Hahn said about it here.
The Chinese government's plan to reduce tariffs it imposed on a slew of US exports is expected to have minimal impact on the overall medtech industry. See what Ralph Ives, AdvaMed's executive VP for global strategy, said about it here.
The US Centers for Disease Control and Prevention (CDC) developed a diagnostic test relatively quickly after news hit that a new coronavirus is spreading across China. Now top health officials say diagnostic manufacturers should help scale up the production of these tests. See what Anne Schuchat, principal deputy director of the CDC, said about it here.
The US FDA cleared Caption Health's Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. See what Caption Health's co-founder and president, Charles Cadieu, said about it here.
Israel start-up Serenno Medical is planning a US launch for the Sentinel continuous urine output monitor for automatic monitoring and detection of acute kidney injury in patients treated in an intensive care unit. See what Serenno's CEO, Tomer Lark, said about it here.
This quarter, Denver, CO-based start-up BioIntelliSense and its strategic partner, UCHealth, will begin clinical testing of the BioSticker, a wearable sensor designed to remotely monitor patients' vital signs that was recently cleared by the US Food and Drug Administration. See what BioIntelliSense's founder and CEO, Jim Mault, said about it here.
Liquid biopsy firm Angle PLC says it will progress a de novo US FDA submission for its Parsortix blood test by March. The company held a Q-submission meeting with the agency last month to discuss regulatory requirements. See what Angle CEO Andrew Newland said about it here.
Medtech counterfeiters are endangering the lives of US patients with their illicit trade in counterfeit devices to American hospitals, and Congress could assist by giving the FDA the authority to destroy the fakes, Johnson & Johnson executive Rich Kaeser says. Check out his comments here.
The new US-Mexico-Canada (USMCA) free-trade agreement aims to make it easier for the three countries to align on inspecting medical device manufacturing facilities by using the Medical Device Single Audit Program (MDSAP). Former US FDA official Kim Trautman explains how Mexico – which currently doesn’t accept the results of MDSAP audits – can come up-to-speed with the program.
The new US Food and Drug Administration commissioner has outlined his top priorities for the agency, including the use of data and patient input to guide regulatory decisions, and feedback from staff on how to improve the agency. See what the agency's commissioner, Stephen Hahn, said about it here.
Boston Scientific recently presented encouraging results of its COMBO study and discussed its partnership with IBM Health using digital health technologies and algorithms to gain an objective understanding of pain. See what Rafael Carbunaru, VP of R&D at Boston Scientific's neuromodulation division, said about it here.
The US Centers for Disease Control and Prevention (CDC) has posted instructions for how to run a real-time reverse transcription polymerase chain reaction (RT-PCR) assay to detect coronavirus and is sharing it with state labs to help detect more cases of the virus. See what Nancy Messonnier, director for CDC's National Center for Immunization and Respiratory Disease, said about it here.
By 2040, the health-care industry will see a major transformation where consumers enabled by digital technologies and open source, secure access to health data will be able to manage their own health, according to a Deloitte analysis. A panel of experts discussed Deloitte's vision for the future of health care during CES 2020. See what Neal Batra, a principal in Deloitte's Life Sciences and Health Care practice, said about it here.
Abbott is encouraged by results from two studies of its Proclaim XR neurostimulation system for chronic pain, presented at the annual North American Neuromodulation Society (NANS) meeting in Las Vegas. See what Steven Falowski of Neurosurgical Associates of Lancester in Pennsylvania said about it here.
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