Medical Devices: Page 125
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Courtesy of Centers for Disease Control and Prevention
BARDA backs push for clinical-grade wearable to detect signs of COVID-19
As companies like Fitbit aim to leverage their wrist-worn devices to monitor for disease symptoms, developers at Northwestern University argue that consumer tech falls short compared to clinical-grade, chest and neck-worn wearables.
By Nick Paul Taylor • July 2, 2020 -
UnitedHealthcare adds coverage of Tandem insulin pumps
The updated policy brings Tandem's technology in network for the nation's largest private payer, widening options for its estimated 250,000 members with Type 1 diabetes, four years after Medtronic pumps gained preferred status.
By Maria Rachal • July 1, 2020 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
UK raises red flags about Stryker's $4B bid for Wright Medical
The Competition and Markets Authority suggested the proposed acquisition would result in Stryker controlling 90% of Britain's total ankle replacement prostheses market.
By Greg Slabodkin • July 1, 2020 -
CMS proposes major market expansion in potential boost for Abbott's MitraClip
Analysts at Cowen estimate the agency's proposal could double or triple the number of U.S. mitral regurgitation patients eligible for the treatment.
By Nick Paul Taylor • July 1, 2020 -
Notified body poll finds multi-month waits for COVID-19 conformity assessments
More than half surveyed by the European Commission expect to spend six months to a year processing applications for certain devices addressing coronavirus.
By Nick Paul Taylor • July 1, 2020 -
Q&A
Q&A: New NESTcc chief on the real-world evidence group's 'pivot point' and COVID-19
Sandra Siami, the new head of the National Evaluation System for health Technology Coordinating Center, says the pandemic's limitations on traditional clinical studies have put alternative sources of device data in the limelight.
By Maria Rachal • June 29, 2020 -
FDA nod to Boston Scientific cardiac monitor clears challenge to Abbott, Medtronic
The medtech giant is betting remote adjustment will put its LUX-Dx insertable system in a position to take on rivals, which have a years-long head start.
By Nick Paul Taylor • June 29, 2020 -
Texas again halts elective surgeries, showing fragile nature of rebound
The renewed restrictions spurred questions about whether states or individual health systems in other hotspots like Arizona and California will enforce similar pullbacks in procedures.
By Maria Rachal • June 26, 2020 -
CMS wants to make home health telemedicine permanent after COVID-19
Agencies would be able to keep using the tech for beneficiaries under the Medicare home health benefit beyond the public health emergency, including remote patient monitoring, according to a proposed rule fact sheet.
By Rebecca Pifer • June 26, 2020 -
Medtronic renal denervation registry shows blood pressure improvements persist at 3 years
The update on Thursday from the medtech giant comes months after Symplicity clinical trial results boosted its long-running effort to win FDA approval.
By Nick Paul Taylor • June 26, 2020 -
Polares raises $40M to target competitive mitral regurgitation market
The medtech plans to finish pilot clinical studies of a transcatheter mitral valve hemi-replacement device, seeking to treat a slice of a population that's proven worthwhile for MitraClip maker Abbott.
By Nick Paul Taylor • June 26, 2020 -
Courtesy of Tandem Diabetes
FDA signals support for automated insulin dosing tech, backing new development tool
As the diabetes technologies meet regulators' safety and efficacy benchmarks, the agency wants to help developers assess patient and family-reported quality of life factors.
By Maria Rachal • June 25, 2020 -
Baxter, B. Braun infusion pumps among millions of devices implicated in Ripple20 cyber alert
Despite warnings that a remote hacker could gain control of a pump, medtechs affected by the vulnerabilities described it as low risk and manageable.
By Greg Slabodkin • June 24, 2020 -
Medtronic Evolut TAVR system gets expanded label in Europe
New indications allow a less-invasive alternative to traditional open heart surgery for a group of severe aortic stenosis patients who tend to be younger and more active, and in higher-risk patients with bicuspid aortic valves.
By Susan Kelly • June 23, 2020 -
FDA affirms potential to miss MDUFA deadlines, weighs virtual advisory panels
Separately, the agency announced virtual meetings in September on using patient preference information in medical device regulatory decisions and considering patient-reported outcomes in evaluating devices.
By Nick Paul Taylor • June 23, 2020 -
FDA
Mainstay wins FDA approval for chronic back pain device following mixed clinical data
The premarket approval comes 19 months after the ReActiv8 neurostimulation system failed a clinical trial aimed at generating data to break into the U.S. market.
By Nick Paul Taylor • June 23, 2020 -
Moody's: US healthcare system rebounds from COVID-19 in May, but uneven road lies ahead
Last month saw improvement in care volumes, but recent pullbacks in hot spots like Arizona may exemplify the bumpiness to come for recoveries at medical device companies.
By Ron Shinkman • June 19, 2020 -
Dufour, Tia. (2020). "White House Press Briefing" [Photograph]. Retrieved from Flickr.
Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says
The agency has grappled with how to leverage real-world data in regulating medical devices, and is now leaning on it to update emergency use authorizations, FDA chief Stephen Hahn said at a forum on Thursday.
By Maria Rachal • June 19, 2020 -
Lack of data encryption for Baxter devices flagged in flurry of DHS alerts
The Department of Homeland Security's cyber agency published four advisories, ranging from 7.5 to 8.6 on its 10-point severity scale, about vulnerabilities in infusion pumps, hemodialysis delivery systems and other tech.
By Nick Paul Taylor • June 19, 2020 -
Courtesy of Tandem Diabetes
Tandem's insulin dosing algorithm OK'd for use in younger kids
FDA's decision to expand the pediatric indication was supported by an NIH-funded trial that found the automated insulin dosing system helped improve time in range for children ages 6 to 13.
By Maria Rachal • June 17, 2020 -
Thermo Fisher, MedRhythms gain breakthrough device designations
A companion diagnostic for certain brain tumor patients and a digital therapeutic for stroke patients with walking impairments are among the latest technologies tapped by FDA for the priority review program.
By Susan Kelly • June 17, 2020 -
Endologix stent graft tied to 5 deaths gets high-risk recall label from FDA
The Class I recall marks an escalation of a polymer leak issue first reported in 2018. Endologix now says the leaks are due to a "material weakness," not incorrect use as it originally concluded.
By Nick Paul Taylor • June 17, 2020 -
Heart rhythm bodies see 'clear concerns' with using wearables to detect arrhythmias
A paper published on Monday by the Heart Rhythm Society, along with counterpart groups in Asia, Europe and Latin America, found wearable-triggered false positives can cause unwarranted concerns and screening.
By Nick Paul Taylor • June 16, 2020 -
Medtronic inks up to $337M in diabetes funding, Blackstone Life Sciences' 1st medtech investment
The announcement came in conjunction with the ADA's Scientific Sessions this weekend, which also featured data on its advanced hybrid closed loop system that will back an FDA premarket approval submission.
By Susan Kelly • June 15, 2020 -
Paclitaxel-coated balloon, stent labels in Europe to have mortality warning update
A notice posted by British medical device regulators outlined 12 affected products including Boston Scientific's ELUVIA stent, Cook Medical's Zilver PTX stent, and Medtronic's IN.PACT Admiral balloon.
By Greg Slabodkin • June 15, 2020
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