Medical Devices: Page 3
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Courtesy of 3M.
3M spins out Solventum
The new company will need to work through debt from the spinoff and sole-source arrangements with 3M.
By Elise Reuter • April 1, 2024 -
Permission granted by Politan Capital Management
Masimo faces another proxy challenge from Politan Capital
The activist shareholder seeks two more seats on Masimo’s board, after both candidates it nominated last spring were voted in.
By Susan Kelly • April 1, 2024 -
Trendline
The EU Medical Device Regulation
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems with continued extensions and outstanding questions still in play.
By MedTech Dive staff -
Permission granted by Osso VR
Osso VR to lay off 67 people at corporate HQ
Art and illustration jobs were heavily affected by the layoffs, which will be complete by May 27.
By Nick Paul Taylor • April 1, 2024 -
Permission granted by Johnson & Johnson
Q&AJ&J’s Aldo Denti on digital technology in orthopedics
The chairman of J&J subsidiary DePuy Synthes talked about how surgical robots and other technologies have contributed to procedures moving to outpatient facilities.
By Elise Reuter • Updated April 1, 2024 -
Courtesy of Roche
Roche wins FDA approval for first molecular malaria blood donor screening test
The company is pitching the test as a way to improve the safety and availability of blood.
By Nick Paul Taylor • March 28, 2024 -
Mario Tama/Getty via Getty Images
J&J in talks to buy Shockwave Medical: WSJ
The healthcare giant could follow up its $16.6 billion acquisition of Abiomed with another deal for a heart device company, the WSJ reported Tuesday.
By Ricky Zipp • March 27, 2024 -
Sarah Silbiger via Getty Images
FDA hits Renovo with warning letter over reprocessed medical devices
The letter accuses Renovo of adding models other than the ones covered by its 510(k) clearances.
By Nick Paul Taylor • March 27, 2024 -
Sara Silbiger via Getty Images
Neuronetics wins FDA clearance for device to treat adolescents with depression
William Blair analysts called the clearance a positive surprise, explaining that the FDA has denied several therapies in the patient population.
By Nick Paul Taylor • March 27, 2024 -
Sarah Silbiger via Getty Images
FDA re-issues ban on electric shock devices
The agency tried to ban the devices in 2020, but a federal appeals court overturned the decision.
By Elise Reuter • March 26, 2024 -
Courtesy of Abbott
Abbott receives CE mark for 6-year insertable cardiac monitor
The device can continuously monitor a patient’s heart rhythms for either three or six years, depending on users’ needs.
By Nick Paul Taylor • March 26, 2024 -
Courtesy of Johnson & Johnson
J&J files for FDA approval of Varipulse pulsed field ablation platform
The company wants to catch up with rival PFA systems from Medtronic and Boston Scientific that have already received FDA authorization.
By Nick Paul Taylor • March 26, 2024 -
Courtesy of BusinessWire/Masimo
Masimo to split off consumer business
The decision comes two years after the pulse oximetry specialist acquired Sound United for its audio brands in a $1 billion deal.
By Susan Kelly • March 25, 2024 -
Sarah Silbiger via Getty Images
Vyaire Medical recalls Airlife resuscitators over defect linked to 2 death reports
The recall covers respiratory support devices made in 2017 or earlier that can fail to provide enough ventilation.
By Nick Paul Taylor • March 22, 2024 -
Permission granted by Stryker
Q&AStryker’s next head of joint replacement talks about new revision, robotics products
Katherine Truppi will become president of Stryker’s joint replacement business on March 31 after more than 20 years at the company.
By Elise Reuter • March 22, 2024 -
Courtesy of Medtronic
Medtronic claims win in Axonics patent row, pushes for jury trial
New rulings from a U.S. patent appeal board are the latest step in the companies’ intellectual property dispute over sacral neuromodulation devices.
By Nick Paul Taylor • March 22, 2024 -
Courtesy of Abiomed/J&J
Abiomed’s latest Impella recall linked to 129 injury, 49 death reports
The J&J subsidiary warned about the risk of the catheter perforating the heart in updated instructions for use. Impella devices were part of four Class I recalls in 2023.
By Elise Reuter • March 21, 2024 -
Courtesy of Insulet Corp.
Insulet names Ana Maria Chadwick CFO
Chadwick succeeds Wayde McMillan, who left last year to become CFO for 3M’s health spinoff.
By Nick Paul Taylor • March 21, 2024 -
Courtesy of Intuitive Surgical
Intuitive aims to keep challengers at bay with new surgical robot
The soft tissue robotics leader looks to set itself apart from upcoming rivals with the first new da Vinci system in 10 years.
By Susan Kelly • March 20, 2024 -
Courtesy of Sequel Med Tech
Deka’s automated insulin delivery system, powered by patient-led app, gets FDA clearance
Sequel Med Tech will sell the new system, which integrates with Tidepool’s Loop insulin dosing algorithm.
By Nick Paul Taylor • March 20, 2024 -
Sara Silbiger via Getty Images
FDA stops two manufacturers from importing plastic syringes
The agency issued import alerts to Jiangsu Caina Medical and Jiangsu Shenli Medical Production because their products didn’t meet quality requirements or were different from FDA-authorized versions.
By Nick Paul Taylor • Updated April 8, 2024 -
Retrieved from Titan on September 12, 2022
Titan Medical to merge with imaging firm Conavi, ending strategic review
The combined company will focus on selling Conavi’s cardiovascular imaging system used in minimally invasive procedures.
By Elise Reuter • March 19, 2024 -
Justin Sullivan / Staff via Getty Images
J&J Medtech, Nvidia partner to bring AI to the operating room
The companies see the collaboration as a way to help facilitate the fast, secure deployment of AI algorithms for surgical decision-making.
By Nick Paul Taylor • March 18, 2024 -
N/A via Getty Images
Deep Dive6 ways the FDA can improve medical device recalls
Experts said improving how adverse events are tracked and requiring manufacturers to use electronic notifications could make devices safer.
By Elise Reuter • March 18, 2024 -
Courtesy of Intuitive Surgical
Intuitive details launch plan for new da Vinci 5 robot
The fifth generation of the company’s flagship robotic surgery system will be introduced in a phased launch.
By Susan Kelly • March 18, 2024 -
Courtesy of Intuitive Surgical
Intuitive lands FDA clearance for new da Vinci robot
The soft tissue robotics leader incorporated new features into the system, from tissue sensing feedback to a smaller size and more comfortable console.
By Susan Kelly • March 15, 2024
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