Medical Devices
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Courtesy of EOFlow
Insulet awarded $452M in EOFlow patent fight
A jury found that competitor EOFlow and former executives misappropriated trade secrets for Insulet’s Omnipod insulin pumps.
By Elise Reuter • Dec. 5, 2024 -
Courtesy of Edwards Lifesciences
Edwards expects new TAVR approval in mid-2025 to boost sales
U.S. approval of an expanded indication for transcatheter aortic valve replacement in patients without symptoms is among the growth catalysts Edwards outlined in an investor day presentation.
By Susan Kelly • Dec. 5, 2024 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Sarah Silbiger via Getty Images
FDA issues final guidance on postmarket updates to AI-enabled devices
By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.
By Elise Reuter • Dec. 4, 2024 -
Violeta Stoimenova via Getty Images
Haemonetics to offload whole-blood business for up to $67M
Selling the assets to Italy’s GVS should help Haemonetics improve its revenue growth and profit margins, analysts said.
By Susan Kelly • Dec. 4, 2024 -
tadamichi via Getty Images
Transmedics appoints Gerardo Hernandez as CFO effective immediately
Hernandez started this week but his predecessor, Stephen Gordon, will continue as a non-executive employee until the end of March and serve as a senior adviser for one year after.
By Nick Paul Taylor • Dec. 4, 2024 -
Permission granted by CMR Surgical
Q&AHow CMR Surgical is taking on robotics’ ‘800-pound gorilla’
“I don't think a monopoly market is healthy,” said CMR co-founder Mark Slack, discussing robotic surgery pioneer Intuitive Surgical’s continuing dominance in the market.
By Susan Kelly • Dec. 3, 2024 -
Courtesy of GE Healthcare
GE Healthcare to buy radiopharmaceutical firm Nihon Medi-Physics
GE Healthcare has identified radiopharmaceuticals as a growth driver for the company and Japan as a key market.
By Elise Reuter • Dec. 3, 2024 -
Permission granted by Movano Health
Movano receives FDA nod for smart ring’s pulse oximeter feature
Movano Health plans to market the Evie Ring to organizations that run clinical trials and healthcare companies that are helping patients manage chronic diseases.
By Nick Paul Taylor • Dec. 3, 2024 -
Permission granted by Johnson & Johnson
J&J appoints Shawn Millerick to lead vision care unit in the Americas
Millerick, who spent time at Abbott and Alcon, is responsible for defining strategy and driving growth at a J&J business that sells products including Acuvue contact lenses.
By Nick Paul Taylor • Dec. 2, 2024 -
Noam Galai via Getty Images
Advamed CEO stresses need for safety, efficacy after Trump picks Makary to lead FDA
Martin Makary, a Johns Hopkins surgeon and researcher, has been critical of the FDA. He could have the most influence over device policy among Trump’s nominees.
By Ricky Zipp • Nov. 27, 2024 -
Permission granted by Embecta
Embecta discontinues insulin patch pump development
CEO Dev Kurdikar said the decision may “come as a surprise” as Embecta just received FDA clearance for a patch pump, but the company “did not intend to do a full market launch of this product.”
By Elise Reuter • Nov. 26, 2024 -
Chip Somodevilla via Getty Images
Trump calls for 25% tariffs on imports from Canada and Mexico
The president-elect also called for additional 10% tariffs on imports from China as part of his day one White House plans.
By Philip Neuffer • Updated Nov. 26, 2024 -
Spencer Platt/Getty Images via Getty Images
Medtronic wins VA contract to install AI-powered endoscopy units
The three-year contract expands Medtronic’s work with the VA to cover the installation of almost 100 more GI Genius endoscopy modules at U.S. centers.
By Nick Paul Taylor • Nov. 26, 2024 -
gorodenkoff via Getty Images
Zimmer wins FDA approval for cementless partial knee implant
The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S.
By Nick Paul Taylor • Nov. 26, 2024 -
Courtesy of Intera Oncology
Boston Scientific to buy Intera Oncology, maker of liver cancer treatment
Intera makes a pump and a chemotherapy drug to treat liver tumors. Boston Scientific sees the purchase as a way to provide more comprehensive cancer treatments.
By Elise Reuter • Nov. 25, 2024 -
gremlin via Getty Images
Sponsored by AltiumFrom SpaceTech to MedTech: What medical device engineering teams can learn from aerospace
High-stakes industries like aerospace and MedTech face similar challenges with outdated workflows. Streamlined, cloud-based systems are driving change.
Nov. 25, 2024 -
Courtesy of Medtronic
Medtronic nets FDA nod for smart insulin pen app
The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous glucose monitor for people who take multiple daily insulin injections.
By Susan Kelly • Nov. 22, 2024 -
Sarah Silbiger via Getty Images
FDA plan would alert public sooner on high-risk device recalls
The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of potentially high-risk recalls and when the public is notified.
By Ricky Zipp • Nov. 22, 2024 -
Courtesy of Medtronic
Medtronic buys surgical instrument developer Fortimedix
Fortimedix develops flexible surgical instruments that are responsive enough to navigate the body and enable endoscopic and minimally invasive procedures.
By Nick Paul Taylor • Nov. 22, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips revises ventilator directions after airflow issue tied to 4 injuries
Aerosol deposits could accumulate on a sensor and affect oxygen delivery, the FDA said in a recall notice. Several of the ventilator models were previously recalled for separate problems.
By Susan Kelly • Nov. 21, 2024 -
Courtesy of Identifeye Health
Verily alum looks to improve access to retinal scans
CEO Vicky Demas joined Identifeye Health, a startup building an AI-supported retinal imaging device, after stints with Google’s sibling Verily and Grail.
By Elise Reuter • Nov. 21, 2024 -
Win McNamee / Staff via Getty Images
Advamed CEO welcomes Dr. Oz as Trump’s pick to lead CMS
Scott Whitaker said Mehmet Oz knows firsthand the impact of medical technologies on disease prevention and treatment. Oz holds a patent on Abbott’s Mitraclip heart device.
By Susan Kelly • Nov. 20, 2024 -
Win McNamee/Getty Images via Getty Images
Trump nominates Dr. Oz to oversee Medicare, Medicaid as CMS head
On Truth Social, President-elect Donald Trump said Oz, who is best known for his eponymous TV show, would take on the “illness industrial complex.”
By Sydney Halleman • Nov. 20, 2024 -
Courtesy of Medtronic
Medtronic’s ablation sales slowed by PFA supply issues
CEO Geoff Martha said the business did not meet internal growth expectations last quarter due to third-party supply issues that have now been resolved.
By Ricky Zipp • Nov. 19, 2024 -
Permission granted by Abbott
Abbott opens plant in Ireland to boost Libre 3 sensor production
More than 800 people will be employed at the plant, which will make more Libre sensors than any of the company’s other facilities.
By Nick Paul Taylor • Nov. 19, 2024
