Medical Devices: Page 122
-
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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Abbott's FreeStyle Libre 2 gets long-awaited iCGM nod from FDA
The designation may stiffen competition for Dexcom, whose G6 device was the sole integrated continuous glucose monitor on the U.S. market. But Abbott's device isn't yet OK'd for use with automated insulin dosing systems.
By Nick Paul Taylor , Maria Rachal • June 15, 2020 -
Key data on Medtronic's 780G, Insulet's Horizon kick off ADA 2020
Abbott, Dexcom and Tandem will also present results at the virtual American Diabetes Association meeting that runs through Tuesday.
By Maria Rachal • June 12, 2020 -
CMS to review at-home ventilation of COPD patients amid variability in device use
Findings from a July Medicare Evidence Development & Coverage Advisory Committee meeting and resulting policy changes could potentially impact ResMed and Philips Respironics.
By Nick Paul Taylor • June 12, 2020 -
Moody's lowers medtech earnings forecast, pegs J&J, Zimmer among hardest hit by COVID-19 fallout
The ratings agency expects the pandemic to curb sales of the large, mostly investment-grade medtechs it covers by 10% this year, with earnings dropping as much as 30%.
By Nick Paul Taylor • Updated June 15, 2020
Previous
