Medical Devices: Page 123
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Surgeons, device makers grow more confident in elective care comeback
As some medtechs indicate forecasts entering Q2 may have been too conservative, a Bain & Co. survey of physicians and administrators suggests rising capacity for elective procedures, albeit without sales reps at full force.
By Maria Rachal • June 11, 2020 -
MedTech Europe pitches virtual audits to clear MDR coronavirus logjam
The trade group contends technology such as smart glasses and webcams can enable notified bodies to view facilities without having to visit in person.
By Nick Paul Taylor • June 11, 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 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Trump admin encourages return to elective care, with precautions
Major surgeries should still be limited as much as clinically possible among higher risk patients, and facilities should prepare to screen all visitors and staff for symptoms, according to new CMS guidelines.
By Shannon Muchmore • June 10, 2020 -
Permission granted by Geisinger Health
Siemens Healthineers, Geisinger ink 10-year digital health partnership
It's one of the medtech's largest partnerships of its kind in North America, as it plans to provide diagnostic imaging and artificial intelligence-enabled applications to the health system over the next decade.
By Greg Slabodkin • June 9, 2020 -
Edwards wins approval to introduce Sapien 3 valve in China
The transcatheter heart device specialist has been eyeing the wealthy, aging nation's untapped market potential for new cardiovascular disease treatments.
By Susan Kelly • June 9, 2020 -
Boston Scientific secures CMS pass-through nod for single-use endoscopes
The alternative payment pathway gives Medicare beneficiaries access to new devices while the agency is still gathering cost data. The company's Exalt D device is the first single-use, flexible duodenoscope to be cleared by FDA.
By Susan Kelly • June 8, 2020 -
Surmodics gets CE mark for Abbott-backed paclitaxel-coated balloon
The company will receive a $10.8 million milestone payment from Abbott, which licensed exclusive commercialization rights to the device for peripheral artery disease patients in 2018 in a bid to take on Medtronic's drug-coated balloons.
By Maria Rachal • June 8, 2020 -
Insulet's pivotal study back on track, setting up Horizon launch in early 2021
The diabetes device maker fixed a software glitch it found with the smartphone-controlled automated insulin delivery system three months ago. Abbott and Dexcom plan to make their CGM tech compatible with the system.
By Maria Rachal • June 5, 2020 -
European Commission lays out timeline for next steps toward MDR, IVDR
Targets for issuing upcoming implementing acts, including those on reprocessing single-use medical devices and the delayed Eudamed database, range from the coming quarter to two years from now.
By Nick Paul Taylor • June 4, 2020 -
PMA major deficiency letters tick up, 510(k) asks for info flatline: MDUFA report
FDA's second quarter report for fiscal 2020, which covered January through March, also showed that the agency still has many guidance document priorities to check off its list.
By Maria Rachal • June 4, 2020 -
Medtronic, Titan Medical ink robotics development, license agreements
The beleaguered robotic surgery company said Thursday it will receive up to $31 million from Medtronic's licensing of technologies. It's the medtech giant's second robotics deal this year as it works to launch its own soft tissue robot.
By Greg Slabodkin • June 4, 2020 -
Haemonetics unveils back-to-back divestitures of blood supply assets
The company saw a 25% to 30% drop in April plasma collections and is now preserving cash, but Wall Street analysts see a few upcoming growth drivers.
By Nick Paul Taylor • June 4, 2020 -
CMS relaxes more value-based model rules in wake of pandemic
Payments and reporting rules related to joint replacements, end stage renal disease and diabetes care were among those addressed.
By Shannon Muchmore • June 3, 2020 -
Jacob Bell/MedTech Dive
Fitbit, NASA get latest FDA emergency authorizations for ventilators
Fitbit's invention is considered an emergency resuscitator, the same label given to a device manufactured by Boston Scientific. NASA's breathing machine builds on a version of a full-fledged ventilator that gained FDA's OK in April.
By Nick Paul Taylor • June 3, 2020 -
JAMA reanalysis goes against 5-year Abbott stent study findings, upping odds of death
The JAMA Internal Medicine report raised doubts about the claim percutaneous coronary intervention is noninferior to bypass surgery and fueled a call for changes to guidelines.
By Nick Paul Taylor • June 3, 2020 -
Many heart device trials 'small and fragile,' come with misleading spin: JAMA study
A JAMA Internal Medicine review of 216 trials of invasive cardiovascular interventions also found commercial sponsor involvement linked to more distortion or misrepresentation of the data.
By Nick Paul Taylor • June 2, 2020 -
Brian Tucker / MedTech Dive - With assets via Getty Images
How 3 smaller medtechs are navigating COVID-19
Neuronetics, TransEnterix and CVRx are all specialized device makers seeking to maintain operations and win new customers at a time when medtech sales are disrupted and supplies to help resume them are tough to come by.
By Maria Rachal • June 1, 2020 -
Four deaths trigger Class I recall for parts of Medtronic's HeartWare system
The FDA issued the safety alert Thursday, its second in quick succession. The ventricular assist device has been the subject of more than a dozen such high-risk recall notices since 2014.
By Nick Paul Taylor • May 29, 2020 -
Health systems, ASCs see restart of elective care taking months despite steps to ease patient fears
The biggest worry among providers is the possibility of an outbreak or second wave, followed by low patient demand and inadequate supplies, according to a new survey from consulting firm Deloitte.
By Shannon Muchmore • May 28, 2020 -
Spine, cancer doc leaders among top recipients of device, drug industry funds, analysis finds
Officials at 10 influential medical associations in the U.S. have extensive financial ties to industry, according to a study published in BMJ.
By Samantha Liss • May 28, 2020 -
EU group sets path for pre-MDR notified body renewal, coronavirus-era surveillance
A new guidance applies to designating authorities and medical device sector notified bodies whose designations would have expired between this week and the Medical Device Regulation's delayed go-live date next May.
By Maria Rachal • May 28, 2020 -
Emergency authorization granted to COVID-19 ICU prediction software
The FDA nod for CLEW Medical's system is among a series of regulatory OKs for products designed to inform care for infected patients.
By Nick Paul Taylor • May 28, 2020 -
FDA Breakthrough Devices Program nears 300 designations
The agency has tapped 50 devices so far this year, with recent nods to Orteq, Thermedical, ArcherDX, Helius, PhotoPharmics and Terumo.
By Susan Kelly • May 27, 2020 -
Analysts saw 30% drop in TAVR growth in April, but Q2 may be better than feared
The Jefferies tracker suggests volume expectations for players in the transcatheter aortic valve replacement market, such as Edwards Lifesciences and Medtronic, may prove a bit conservative.
By Nick Paul Taylor • May 27, 2020 -
Medtechs eye key role of ASCs in return of elective care
Elective procedures were increasingly moving from hospitals to lower-cost ambulatory surgery centers prior to COVID-19. Now, ASCs may have a new advantage as a setting where patients feel safer returning to care.
By Maria Rachal • May 26, 2020
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