Medical Devices: Page 121
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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 -
Explore the Trendlineâž”
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 -
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 -
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 -
Inari Medical launches IPO, shares take off
The maker of mechanical thrombectomy devices sees a $3.6 billion annual U.S. market opportunity. It had the best first-day performance of 74 initial public offerings launched so far this year, Bloomberg calculated.
By Susan Kelly • May 26, 2020 -
ResMed, Medtronic embrace remote tech amid COVID-19, say it's here to stay
The crisis has sped adoption of digital health technologies to help hospitals create safe physical distances between healthcare workers and patients. Execs say some could become permanent products.
By Greg Slabodkin • May 26, 2020 -
Martha plots M&A, Hugo robot sees delay: Takeaways from Medtronic's Q4
Despite the negative impacts of COVID-19 on revenue in the latest quarter, the medtech giant has its strongest balance sheet in years and is looking for acquisition opportunities in the pandemic landscape.
By Maria Rachal , Greg Slabodkin • May 22, 2020 -
FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions
Companies that market medical devices under premarket approvals or humanitarian device exemptions can make limited modifications to design and production without giving prior notice, according to special guidance.
By Nick Paul Taylor • May 22, 2020 -
April was dismal for US hospitals, with long road ahead, surveys find
Operating margins plummeted 174% last month compared to April 2019 and were down 118% from March of this year as surgeries, ER visits and outpatient appointments declined drastically during the COVID-19 pandemic.
By Shannon Muchmore • May 21, 2020 -
Medtronic's revenue dropped 26% in Q4 as coronavirus hit broadly
New CEO Geoff Martha told investors Thursday nearly all sides of the business were negatively impacted by the pandemic's effects.
By Greg Slabodkin • May 21, 2020 -
Hospitals push FEMA to form broad supply pact with medtech
The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.
By Nick Paul Taylor • Updated May 26, 2020 -
AdvaMed, health systems set ground rules for return of sales reps
Hospitals, nurses and the medtech industry issued guidance to pave the way for device company representatives to re-enter healthcare facilities.
By Susan Kelly • May 20, 2020 -
COVID-19 drives EC to change rules on notified body designations
The European Commission is allowing certain deviations from normal procedures governing notified bodies, enabling renewal of designations under the outgoing device regulations without performing on-site assessments.
By Nick Paul Taylor • May 20, 2020
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