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

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

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

Abbott device growth returns as Wall Street queries staying power of COVID-19 test boom

CEO Robert Ford argued that focusing on how coronavirus test demand will evolve "misses the point," touting the longer-term benefits of its now-expanded diagnostic platforms footprint.

By Maria Rachal • Oct. 21, 2020

FDA floats framework to message cybersecurity threats to patients

The proposal, which has the agency and industry sharing responsibility for making the information easy to find, comes as the risks to medical devices continue to grow.

By Nick Paul Taylor • Oct. 21, 2020

Robotic surgery startups help drive Q3 medical device funding over $5B, an all-time high

CB Insights also listed the progress of neuromodulation devices and Medtronic's deals in diabetes and neurosurgery as other highlights.

By Nick Paul Taylor • Oct. 20, 2020

FDA, medtechs envision new era for clinical trials amid COVID-19 shake-up

Medtronic, for example, has faced "very significant delays" in getting products approved as a result of research disruptions, the company's VP of global clinical affairs said during a discussion at TCT.

By Maria Rachal • Updated Oct. 20, 2020

Future of COVID-19 products, device shortages, CDS top CDRH 2021 to-do list

Regulators aim to publish final guidance on five topics and draft documents on another dozen priority areas in the coming year. A few of the goals are carryovers as priorities shifted during the public health emergency.

By Susan Kelly • Oct. 19, 2020