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

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

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

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

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