Medical Devices
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Retrieved from Michigan Medicine on October 02, 2026
Edwards’ adjustable heart valve for children lands FDA approval
The device could help young patients avoid multiple open-heart surgeries as they grow, FDA officials said.
By Susan Kelly • Oct. 2, 2026 -
FDA to prioritize guidance on AI, surgical robots next year
The FDA outlined its A-list and B-list guidance priorities for the 2027 fiscal year.
By Nick Paul Taylor • Oct. 2, 2026 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
FDA selects first 5 participants for READI-Home initiative
The innovation challenge is focused on developing home devices that could help reduce hospital readmissions.
By Elise Reuter • Oct. 1, 2026 -
Medtronic drug-coated balloon gets FDA breakthrough status
Medtronic plans to study the device in patients with peripheral artery disease below the knee, a historically difficult condition to treat.
By Susan Kelly • Oct. 1, 2026 -
Medtronic reveals cardiac mapping and ablation software clearances
The regulatory authorizations come as Medtronic looks to differentiate itself in the fast-growing pulsed field ablation market targeted by rivals Abbott, Boston Scientific and J&J.
By Nick Paul Taylor • Oct. 1, 2026 -
US-China trade board carves path for tariff relief on $60B of goods
The board has proposed lower tariffs on U.S.-bound household goods and toys, but the White House did not specify reduction amounts or an implementation date.
By Max Garland • Sept. 30, 2026 -
Sofinnova raises 82M euros to fund medtech startups
The venture capital firm expects to launch up to eight new medtech ventures over the next five years.
By Susan Kelly • Sept. 29, 2026 -
Carlsmed names new CFO
Former ZimVie CFO Richard Heppenstall fills the vacancy created by the departure of Leo Greenstein, who is leaving Carlsmed to pursue other professional interests.
By Nick Paul Taylor • Sept. 29, 2026 -
FDA issues draft guidance for surgical robots
A two-day public workshop on evaluating robotic surgery systems with autonomous or remote capabilities is also on the agency’s agenda, as telesurgery advances globally.
By Susan Kelly • Sept. 28, 2026 -
GE HealthCare to explore applying generative AI to radiation therapy workflows
The company has teamed up with a Mass General Brigham research team to help care teams access patient-specific information.
By Nick Paul Taylor • Sept. 28, 2026 -
Intuitive expands push into cardiac market with CE mark
After de-emphasizing heart surgery for decades due to limits with its earlier platforms, the surgical robot maker is eyeing the large market in cardiovascular disease treatment.
By Susan Kelly • Sept. 25, 2026 -
Precision Neuroscience raises $250M for brain-computer interface work
The Series D round is part of a surge in investment into BCI startups and brings Precision Neuroscience’s total funding to $430 million.
By Nick Paul Taylor • Sept. 25, 2026 -
BD hires Arthur Hu as chief information and digital officer
BD predicted that Hu’s experience at Lenovo will be an important advantage as technology becomes increasingly central to how leading medtech companies operate.
By Nick Paul Taylor • Sept. 24, 2026 -
CVRx names John Landry as CFO
Landry joins in the aftermath of an investor’s call for the sale of the heart failure device company.
By Nick Paul Taylor • Sept. 23, 2026 -
Deep Dive
Telerobotic surgery is advancing around the world. Will the US embrace it?
Medtech companies are preparing for a day when telesurgery, performed by a surgeon often hundreds of miles from the patient, could become a viable option for more people.
By Susan Kelly • Sept. 23, 2026 -
Cordis wins FDA approval for sirolimus-eluting balloon
The approval gives physicians an alternative to uncoated balloons and Boston Scientific’s paclitaxel-coated device.
By Nick Paul Taylor • Sept. 22, 2026 -
Retrieved from CooperSurgical on September 21, 2026
Activist investor urges Cooper Companies to replace CEO, sell some assets
Citing “chronic underperformance,” Jana Partners is calling for new leadership and for the company to evaluate the sale of its fertility and medical device assets.
By Elise Reuter • Sept. 21, 2026 -
Neptune Medical secures FDA nod for endoscopy robot
The robot is intended to give physicians more control of the endoscope during a colonoscopy procedure, which can help with detection and removal of lesions.
By Susan Kelly • Sept. 18, 2026 -
FDA clears vessel-sealing device for Medtronic’s Hugo robot
Widely adopted in open and laparoscopic surgeries, the LigaSure instrument is now available for use with the Hugo robotic system.
By Nick Paul Taylor • Sept. 17, 2026 -
Recor Medical ex-CEO Lara Barghout joins Medtronic
Barghout, who led Recor when it won FDA approval of the first renal denervation treatment for hypertension, is the new president of Medtronic’s Interventional Cardiology Therapies business.
By Susan Kelly • Sept. 16, 2026 -
CMS expands ACCESS pilot to boost use of digital health tech
The CMS is expanding the number of covered conditions under the program to include heart failure, COPD, substance use disorders and tobacco cessation.
By Elise Reuter • Sept. 16, 2026 -
J&J sells Laminar LAA closure assets it bought 3 years ago
The decision is part of J&J’s strategy to prioritize resources for the greatest impact and positions Laminar for success under dedicated ownership, a spokesperson said.
By Susan Kelly • Sept. 16, 2026 -
Dexcom gives CFO Jereme Sylvain expanded role
Sylvain will work as chief operating officer of the diabetes technology company while continuing as its CFO.
By Nick Paul Taylor • Sept. 16, 2026 -
OIG urges crackdown on equipment suppliers in Medicare Advantage
The agency says the CMS and MA organizations aren’t doing enough to screen durable medical equipment providers, especially out-of-network companies that aren’t enrolled in Medicare.
By Eric Wicklund • Sept. 15, 2026 -
Intuitive single-port robot earns CE mark for new indication
Gaining authorization for transvaginal gynecologic procedures expands the list of indications for da Vinci SP in Europe.
By Nick Paul Taylor • Sept. 15, 2026