Canada regulations news for medical devices and IVDs

The new Canadian requirement for summary reports goes into effect on 18 Dec. 2021. Learn how to leverage your PSUR for an efficient submission.

By Nancy Morrison, RQM+ • Dec. 13, 2021

Edwards sees double-digit 2022 sales growth boosted by another TAVR jump

The cardiac device maker estimated 12% to 15% growth next year for transcatheter aortic valve procedures. During its annual investor conference, Edwards also updated future growth projections for key markets.

By Ricky Zipp • Dec. 9, 2021

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

FDA floats independent contractor to track MDUFA hiring following medtech pressure

The agency made the offer during the Medical Device User Fee Amendments V meetings in response to industry negotiators who want a clearer picture of how the program uses the money it receives.

By Nick Paul Taylor • Dec. 9, 2021

Study finds surgery volumes bounced back after 2020 COVID-19 shutdown, confirming medtech sales trends

Confounding factors such as healthcare staffing shortages caused the delta variant headwind to drag on — and, now, rapidly increasing inpatient volumes are leading U.S. hospitals to once again delay surgical procedures.

By Nick Paul Taylor • Dec. 9, 2021

Study links cochlear implants to new bone formation, long-term residual hearing loss

Ultra-high spatial resolution CT detected new bone formation in two-thirds of the patients within four years of implantation, which adversely affected their long-term hearing preservation, according to a study in the journal Radiology.

By Nick Paul Taylor • Dec. 8, 2021

Implantable cardioverter defibrillators are underused in women, racial minorities: study

The proportion of people who received an ICD rose from 11.6% in 2003 to 17% in 2014, according to the Mayo Clinic study. However, that overall figure masks differences between patient groups.

By Nick Paul Taylor • Dec. 8, 2021

Tandem Diabetes Care targets 1M customers by 2027

The insulin pump maker expects to triple its installed units over the next five years behind new product launches and capturing market share as use among Type 1 and Type 2 patients is projected to take off.

By Ricky Zipp • Dec. 7, 2021

Cancer treatments lead latest FDA breakthrough device designations

The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.

By Nick Paul Taylor • Dec. 7, 2021

Insulet's Omnipod 5 insulin pump cleared by FDA after months of delays, sending shares up 9%

The clearance better positions Insulet to compete with rival Tandem Diabetes Care, and comes while Medtronic's diabetes group is managing multiple product safety problems.

By Susan Kelly , Ricky Zipp • Updated Jan. 28, 2022

Can medical device reps have a healthy work-life balance and a growing career? Yes and yes.

Medical device reps face long work days and extensive travel schedules, but technology is changing the way they do business.

Dec. 6, 2021

Device recalls jumped 36% in Q3, first quarterly increase since 2020: report

The primary reasons for recalls in the quarter were software issues, which have been the leading causes in 21 of the last 22 quarters, according to Sedgwick's November U.S. product recall index.

By Ricky Zipp • Dec. 3, 2021

NuVasive resumes US shipments of titanium-based orthopaedic devices, gets FDA thumbs up

The agency voiced its support for the reintroduction of the Precice products, telling healthcare providers that the availability of the devices is in the best interests of patients as the benefits outweigh the known risks.

By Nick Paul Taylor • Dec. 2, 2021

EU finalizes implementing regulation for Eudamed medical device database

The European Commission has provided a framework for the basic operation of the system, slated for a May 2022 launch, including how to access it, what it will do in the event of a database malfunction and IT security measures.

By Nick Paul Taylor • Dec. 2, 2021

Medical device security continues to be casualty of hospital-medtech divide

FDA says manufacturers and hospitals are both responsible for protecting devices from growing cybersecurity threats. However, experts say healthcare providers carry a much heavier load.

By Greg Slabodkin • Dec. 1, 2021

Cyber playbook sets out strategies for modeling threats to medical devices

The FDA-funded guide arrives against a backdrop of calls from the agency for the medtech industry to step up its threat modeling throughout the device lifecycle in order to strengthen cybersecurity and patient safety.

By Nick Paul Taylor • Dec. 1, 2021

FDA updates eSTAR ahead of expanding filing template for De Novo submissions

The platform has been available for manufacturers to voluntarily submit 510(k) submissions since September 2020. The agency will start accepting De Novo applications when a final rule takes effect early next year.

By Nick Paul Taylor • Nov. 30, 2021

4 takeaways from Medtronic's latest earnings report

The medtech giant on Tuesday discussed a wide range of issues impacting the company, from whether procedure volumes rebounded in November to the chances of it spinning off non-core or underperforming business units.

By Nick Paul Taylor • Nov. 24, 2021

Roundup: COVID-19 surge, hospital labor shortages, supply chain issues hit medtechs in latest earnings

After the industry began recovering in the first half of the year, top companies reported that the delta variant surge put a drag on businesses last quarter.

Nov. 23, 2021

Medtronic blames revenue miss on COVID-19 resurgence, hospital staffing shortages

CEO Geoff Martha said the medtech was hit in its second quarter by pandemic-related challenges that weighed on procedure volumes, particularly in the U.S.

By Greg Slabodkin • Nov. 23, 2021

FDA resumes domestic surveillance inspections as omicron cases decline

The regulator has restarted the examinations, following a six-week freeze in response to the variant's surge. FDA plans to conduct foreign prioritized inspections starting in April.

By Nick Paul Taylor • Updated Feb. 7, 2022

Rise of TAVR increased overall aortic valve replacement, improved outcomes: study

The growth of transcatheter procedures has driven a 60% increase in aortic valve replacement and cut one-year mortality in older adults, according to data published in the Journal of the American College of Cardiology.

By Nick Paul Taylor • Nov. 23, 2021

Latest breakthrough device designations go to brain-computer interface, exo-suit

Regulatory privileges were awarded to Blackrock Neurotech's brain-computer interface, designed to assist immobile patients with performing activities, and ReWalk Robotics' exo-suit, which is intended to help stroke patients walk. 

By Nick Paul Taylor • Nov. 22, 2021

New iRhythm CEO talks Medicare pricing, larger medtech competitors, international markets

"I think the near-term noise is something that we'll work through, but the underlying technology has never been questioned," Quentin Blackford told MedTech Dive.

By Ricky Zipp • Nov. 19, 2021

Stryker dismisses robotics threat from J&J, Zimmer with bullish forecast

CEO Kevin Lobo said during Thursday's analyst day that the company is "poised and ready to pounce" if valuations fall as Stryker looks to leverage M&A in long-term growth plans.

By Nick Paul Taylor • Nov. 19, 2021

Medtronic leadless pacemaker flagged by FDA for safety risks

The agency said in a letter to healthcare providers that cardiac perforations associated with Medtronic's Micra device are more likely than traditional pacemakers to be associated with serious complications, such as death.

By Nick Paul Taylor • Nov. 18, 2021