Medical Devices

NEJM commentary calls for 510(k)s for OTC hearing aids after senators pan FDA delay to rule

While critics of the delay acknowledged FDA's coronavirus-related workload this year, the agency has failed to come through with the draft regulation required by a 2017 law.

By Nick Paul Taylor • Nov. 23, 2020

Abbott on track to top Q4 CGM sales estimates, rise in US FreeStyle Libre scripts suggests

UBS analysts predict the franchise will grow around 40% in the quarter, well above estimates, based on an increase in prescriptions for the new integrated continuous glucose monitor.

By Nick Paul Taylor • Nov. 23, 2020

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By MedTech Dive staff

J&J readies rivals to da Vinci and Mako, eyeing new markets for robots

Johnson & Johnson won't begin marketing its orthopaedics platform until 2021, with general surgery offering Ottava a few years behind, but its Monarch robot targeting lung cancer diagnosis continues to gain ground.

By Maria Rachal • Nov. 20, 2020

MedTech Europe backs proposed EU Health Union but flags potential hangups

The trade group fears moving responsibility for administering the IVDR and MDR expert panels to the European Medicines Agency could slow deployment.

By Nick Paul Taylor • Nov. 20, 2020

Notified bodies report early success with remote audits but challenges remain

While there have been benefits to going remote during the pandemic, 57% of those polled by a European trade group say they take longer than on-site assessments and most encounter problems due to poor network connections.

By Nick Paul Taylor • Nov. 20, 2020

Older patients less willing to have elective procedures as COVID-19 surges: survey

Patient sentiment has deteriorated since September, according to findings from Needham, even as medtech companies have taken steps to encourage a return to care.

By Nick Paul Taylor • Nov. 19, 2020

Hospitals across US cancel elective procedures — again

Although distinct from wholesale shutdowns earlier this year, health systems from Chicago to El Paso are again putting off non-emergency care, which often includes joint replacement surgeries.

By Hailey Mensik • Nov. 18, 2020

iRhythm wearable linked to more afib diagnoses, though road to payer uptake called 'grind'

Analysts were broadly encouraged by the new data, while cautioning that unlocking the market for this population will take time. Wall Street took a wait-and-see approach, with the stock closing down 9% on Tuesday.

By Nick Paul Taylor • UPDATED: Nov. 18, 2020 at 10:11 a.m.

Boston Scientific calls it quits on Lotus Edge TAVR program

Shares fell 10% after a voluntary recall led Boston Scientific to end the product line entirely. The surprise move gives Medtronic and Edwards Lifesciences the opportunity to gain back ground in the near term.

By Maria Rachal • UPDATED: Nov. 17, 2020 at 11:16 a.m.

Medtronic trial suggests cryoablation bests drug therapy in atrial fibrillation

Ablation was successful in 75% of patients at 12 months, compared to a 45% success rate in the drug cohort, according to a company-sponsored study in the New England Journal of Medicine.

By Nick Paul Taylor • Nov. 17, 2020

FDA draft guidance expands electromagnetic compatibility advice for medtechs

A new document builds on a very brief final guidance from 2016, as the agency looks to gather the right information on how devices function in intended electromagnetic environments.

By Nick Paul Taylor • Nov. 17, 2020

BD's Alaris infusion pumps flagged for cybersecurity vulnerability

The Department of Homeland Security alert scored the issue 6.5 out of 10 and said a successful attack that exploited the weakness could force operators to manually program the pumps.

By Nick Paul Taylor • Nov. 13, 2020

3 ways Biden's COVID-19 approach could impact medtech

A new administration — regardless of who's in power — means device makers can anticipate shifts at key government agencies like the FDA.

By Maria Rachal , Greg Slabodkin • Nov. 12, 2020

Dialysis device maker Outset Medical tops revenue targets in first quarter since IPO

The portable dialysis system company benefited from the pandemic environment, which is driving increased interest in home dialysis and growth in its base business. 

By Nick Paul Taylor • Nov. 12, 2020

Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills

The Senate appropriations committee released a series of budget proposals for fiscal 2021. FDA's device center is slated for a 5% funding increase, making it one of the only centers set to receive less than requested.

By Nick Paul Taylor • Nov. 11, 2020

UK fleshes out post-Brexit approach to regional medical device marking

The Medicines and Healthcare products Regulatory Agency further clarified conformity marking as medtechs prepare for the transition period to end.

By Nick Paul Taylor • Nov. 11, 2020

Top picks for who could run HHS, CMS under Biden

Former Obama adviser and ACA architect Ezekiel Emanuel as well as high-profile state officials like New Mexico Governor Michelle Lujan Grisham are among those considered likely advisers.

By Rebecca Pifer • Nov. 10, 2020

What Intuitive is looking for through its new $100M venture fund

Surgical robots have been Intuitive's sweet spot. As the company moves into VC for the first time, its broader focus on minimally invasive care, including interest in digital tools and precision diagnostics, opens more opportunities.

By Maria Rachal • Nov. 09, 2020

Zimmer reports record robot installs, ASC-inspired M&A

While the company benefited from a rebound in elective procedures, execs warned investors the recovery slowed as the third quarter drew to a close.

By Nick Paul Taylor • Nov. 06, 2020

Insulet, Tandem raise 2020 outlooks as diabetes tech proves resilient to COVID-19 headwinds

Concerns that the pandemic would depress the number of new insulin pump customers have played out less severely than predicted.

By Maria Rachal • Nov. 06, 2020

Patients shirked diagnostic testing, in-person preventive care amid telehealth boom this spring

Routine preventive services that can't be done virtually, such as mammograms and colonoscopies, plunged 65% in March and April compared to the year prior, according to an analysis published in JAMA Network Open.

By Hailey Mensik • Nov. 05, 2020

Even if Biden wins, divided Congress stifles chance for more progressive health policies

Results of the election are not final and may be uncertain for weeks, but the most likely scenario points to mostly incremental change, a positive for many parts of the healthcare sector.

By Shannon Muchmore • Nov. 05, 2020

BD returns to growth on COVID-19 antigen tests, but predicts price erosion

The company said sales related to its rapid testing could hit $1.5 billion next year, with the prospect of demand continuing into 2022. However, management thinks Abbott's $5 test could drive down its pricing.

By Nick Paul Taylor • Nov. 05, 2020

Docs paid by ICD makers more likely to favor manufacturer: JAMA study

Yale researchers found patients were more likely to receive certain cardiac devices from the company that made the largest payment to their doctor, though quality of care did not appear to be affected.

By Susan Kelly • Nov. 04, 2020

Stryker closes Wright Medical acquisition after year-long wait

The Kalamazoo, Michigan-based medtech highlighted the shoulder, elbow, wrist, hand, foot and ankle devices it's gained, along with preoperative planning technology, now that the deal is final.

By Maria Rachal • UPDATED: Nov. 11, 2020 at 8:48 a.m.