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

Explore the Trendline➔

Top 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

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

FDA grants 510(k) to Abiomed's artificial lung, teeing up use in COVID-19

While LivaNova and Medtronic already sell ECMO devices, Abiomed is focusing on a relatively compact design to differentiate the device from the pack.

By Nick Paul Taylor • Oct. 27, 2020

Despite recent rebound, hospitals find admissions still well below pre-pandemic levels

Trends from health systems in New York and California suggest patients may have lost health insurance as a result of the economic fallout from the pandemic

By Ron Shinkman • Oct. 26, 2020

FDA, Philips warn of data bias in AI, machine learning devices

The comments come 18 months after FDA unveiled a yet-to-be-finalized framework for modifying AI/ML-based software as a medical device using real-world learning and adaptation.

By Greg Slabodkin • Oct. 26, 2020

Stryker buyout of Wright poised to pass 1-year mark without closing

CEO Kevin Lobo said last month the $5.4 billion buyout, which has faced antitrust hurdles, was on track to be finalized in early October.  

By Maria Rachal • Oct. 26, 2020

EU notified body designation pipeline points to IVDR bottleneck

An update from the European Commission reveals only a few notified bodies are likely to join the four already designated over the coming months.

By Nick Paul Taylor • Oct. 26, 2020

Medtech Q3 results signal diagnostics boom, mixed bag on device growth

Hologic, BD and Zimmer Biomet are among the medtechs set to add to the growing mass of late summer data points this week.

Updated Nov. 2, 2020

Neuromod devices at the fore in latest FDA breakthrough designations

Liquid biopsies also stand out as an area where U.S. regulators are encouraging development and prioritizing review.

By Nick Paul Taylor • Oct. 23, 2020

Robotic surgery pricier, with no measurable benefit in hernias: Cleveland Clinic trial

Certain procedures with Intuitive's da Vinci took 55% longer than those done laparoscopically, which drove up costs. The findings also punctured the perception that robotic platforms may reduce postoperative pain. 

By Nick Paul Taylor • Oct. 22, 2020

Edwards TAVR sales grow 6% but Q4 forecast disappoints

A resurgence of COVID-19 cases in Europe and parts of the U.S. creates uncertainty about the fourth quarter, execs acknowledged, but noted talks with hospitals suggest widespread global disruption to surgeries is unlikely.

By Nick Paul Taylor • Oct. 22, 2020