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

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

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. 9, 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. 6, 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. 6, 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. 5, 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. 5, 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. 5, 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. 4, 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

MedPAC pans CMS idea to lean on commercial payers for Medicare coverage decisions

The advisory group warned against threats to transparency and rigor in response to a proposed rule defining the term "reasonable and necessary" and adding a faster coverage pathway for FDA-designated breakthrough devices.

By Susan Kelly • Nov. 3, 2020

CMS finalizes rejection of Baxter, Outset dialysis device add-on payments

The broader, now final, ESRD rule is meant to support use of equipment and supplies for at-home dialysis treatment.

By Nick Paul Taylor • Updated Nov. 3, 2020

FDA approves Boston Scientific paclitaxel-coated balloon as sector revives after scrutiny

Studies have failed to confirm a late mortality signal that prompted an agency warning and advisory committee meeting in 2019. Boston Scientific now sees the recovery of the devices as a tailwind for its business.

By Nick Paul Taylor • Nov. 3, 2020

Stryker, NuVasive, Globus forge on with surgical robots through COVID-19

Despite worries that the pandemic's financial strain on customers may slow adoption of the expensive tools for knee, hip and spine surgery, device makers' Q3 reports reveal momentum.

By Maria Rachal • Oct. 30, 2020

Medtronic to pay $9.2M to settle DOJ influence, kickback allegations

The medtech giant is accused of offering "lavish" benefits in promoting a certain infusion pump to a South Dakota neurosurgeon, and misreporting those payments under a required CMS program.

By Nick Paul Taylor • Oct. 30, 2020

Medtronic acquires thyroid surgery tech in 7th tuck-in deal of 2020

An addition to the medtech's pandemic-battered ENT business, Ai Biomed's PTeye system won De Novo authorization from FDA in 2018 for its ability to help surgeons spare important calcium-regulating tissue during procedures.

By Maria Rachal • Oct. 29, 2020

Baxter Q3 sales up 4% as virus-driven demand offsets headwinds

The renal care business continues to grow during the pandemic but lower ER utilization and fewer hospitalizations, particularly in the U.S., hurt revenues by more than $65 million in the quarter.

By Greg Slabodkin • Oct. 29, 2020

Teleflex lines up $525M to buy hemostat specialist Z-Medica

The medtech predicts the trauma surgery and emergency medicine-focused products will begin adding up to $70 million in revenue next year, providing growth drivers outside its key interventional urology segment.

By Maria Rachal • Oct. 29, 2020

CMS competitive bidding process fails to drive expected savings, sparking rethink

While Needham analysts contend one action removes an overhang for Inogen, Invacare and ResMed, those at Jefferies see a "major negative" in the agency's determination to lower rates outlined in a proposed rule. 

By Nick Paul Taylor • Oct. 29, 2020

Smith & Nephew lays path to 10% growth for acquired Integra assets

The medtech is moving deeper into the extremity orthopaedics turf fought over by the likes of Zimmer Biomet and Stryker acquisition target Wright Medical.

By Nick Paul Taylor • Oct. 29, 2020

Dexcom revenue growth dampened amid shift to lower pharmacy prices

The 26% rise in Q3 revenue, which came from a nearly 40% increase in sales, beat analysts' consensus estimates and were good enough for the company to raise its 2020 outlook. Still, shares closed down 9% on Tuesday. 

By Maria Rachal • Oct. 28, 2020

Neovasc angina device fails to win FDA panel backing, stock tumbles 43%

By a vote of 17-1, experts on FDA's circulatory system devices panel said the available data did not provide reasonable assurance of effectiveness, though most thought the Reducer system was safe for patients.

By Susan Kelly • Oct. 28, 2020

Boston Scientific sales not yet back to growth as Watchman hit compounds COVID-19 impacts

The medtech is aiming for organic revenue growth in Q4 after falling 5.7% in Q3. CEO Mike Mahoney said estimating the remaining procedure backlog and new patient funnel "remain a challenge" and vary by business and region.

By Nick Paul Taylor • Oct. 28, 2020

MDUFA V talks kick off as FDA grapples with onslaught of COVID-19 submissions

Medtech industry groups broadly expressed a desire to maintain the status quo after FDA Commissioner Stephen Hahn described the strain on agency workers under MDUFA IV as unsustainable.  

By Maria Rachal • Oct. 28, 2020

Neovasc refractory angina treatment faces FDA panel review

The agency's ultimate approval decision on the Canadian company's CE-marked device has important financial implications for the medtech, which saw its revenue plunge and operating loss deepen in the second quarter.

By Susan Kelly • Oct. 27, 2020