Medical Devices: Page 2
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"Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
FDA’s plan to expand device surveillance faces challenges, GAO finds
Funding issues and limited use of unique device identifiers are hurdles to expanding an FDA system to monitor medical device safety, the federal watchdog said.
By Nick Paul Taylor • Aug. 21, 2024 -
Retrieved from Masimo on August 20, 2024
Masimo’s consumer audio brands attract more suitors
Negotiations with a potential joint venture partner will continue while Masimo initiates discussions with new parties that have expressed interest in the consumer audio business.
By Susan Kelly • Aug. 21, 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 -
Permission granted by Johnson & Johnson
J&J to buy heart failure implant maker V-Wave for up to $1.7B
J&J has agreed to pay $600 million upfront for the private company as it works to expand its portfolio of cardiovascular devices.
By Susan Kelly • Aug. 20, 2024 -
Edwards continues M&A spree with Genesis’ TAVR tech
Edwards, which has made a series of acquisitions in recent months, is also investing $25 million in Singapore-based Genesis Medtech.
By Susan Kelly • Aug. 19, 2024 -
Permission granted by Histosonics
Histosonics raises $102M for noninvasive treatment to destroy tumors
Using sound waves to break down tumor tissue can offer patients with liver cancer an alternative to surgery, radiation and chemotherapy.
By Susan Kelly • Aug. 19, 2024 -
Erin Scott / U.S. White House. Retrieved from Flickr.
Biden pledges $150M for medical tech to improve cancer surgery
Awards include funding for microscopy and imaging tools to help surgeons ensure all cancer is removed during a procedure.
By Elise Reuter • Aug. 16, 2024 -
Permission granted by Stereotaxis
Stereotaxis earns CE mark for new surgical robot
CEO David Fischel said the platform, called GenesisX, is designed to address challenges hospitals have faced when installing the company’s earlier robotic systems.
By Susan Kelly • Aug. 15, 2024 -
Courtesy of Tandem Diabetes Care
Tandem warns iPhone app still draining insulin pump batteries
Despite a software update in March, users are still reporting that the app is rapidly depleting their insulin pump batteries, causing unexpected shutdowns.
By Elise Reuter • Aug. 15, 2024 -
Permission granted by Neuronetics
Neuronetics inks Greenbrook merger to acquire treatment centers
William Blair analysts said the deal changes Neuronetics’ profile “from device-centric to a device-service business operating brick-and-mortar facilities.”
By Nick Paul Taylor • Aug. 15, 2024 -
Retrieved from Otsuka Precision Health on August 14, 2024
Otsuka Precision Health launches first digital therapeutic for depression
Intended to supplement medications, the six-week, app-based treatment will cost $50 on a cash-pay basis.
By Elise Reuter • Aug. 14, 2024 -
Retrieved from Globus Medical on August 14, 2024
Globus receives warning letter over spine navigation robot
The FDA said Globus delayed reporting complaints about misplaced screws, despite information that “reasonably suggests” the Excelsius GPS system malfunctioned.
By Nick Paul Taylor • Aug. 14, 2024 -
Tim Boyle via Getty Images
Baxter agrees to sell kidney care unit to Carlyle for $3.8B
Selling the business, called Vantive, rather than spinning it off, should maximize shareholder value and give Baxter more flexibility to pursue other growth opportunities, the company said.
By Susan Kelly • Aug. 13, 2024 -
Courtesy of Medtronic
Medtronic wins FDA approval for asleep deep brain stimulation
Medtronic said Monday it is the first company to receive FDA approval to offer DBS surgery while a patient is asleep or awake.
By Nick Paul Taylor • Aug. 13, 2024 -
Retrieved from Breas Medical on August 12, 2024
Breas Medical flags risk of formaldehyde exposure in ventilators
Testing showed the potential for short-term exposure to elevated levels of formaldehyde under specific conditions.
By Nick Paul Taylor • Aug. 12, 2024 -
Courtesy of 3M
Solventum raises earnings forecast after first independent quarter
Four months after separating from 3M, CEO Bryan Hanson told investors on Solventum’s first earnings call that “a lot could have gone wrong, and it didn’t.”
By Elise Reuter • Aug. 9, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls infusion pumps over software issues
The devices may fail to emit alarms, have unresponsive stop and power keys, and reveal passwords.
By Nick Paul Taylor • Aug. 9, 2024 -
Permission granted by Axogen
Axogen names ex-Abbott exec Michael Dale as CEO
Dale will replace Karen Zaderej, who is leaving the provider of peripheral nerve injury devices after 14 years as CEO.
By Nick Paul Taylor • Aug. 9, 2024 -
Courtesy of Orthogrid Systems
Zimmer to buy surgical navigation company Orthogrid
CEO Ivan Tornos said Zimmer hopes to grow its market share in hip procedures with the purchase. He also shared an update on the company’s new shoulder surgical robot.
By Elise Reuter • Aug. 8, 2024 -
Rebecca Pifer/MedTech Dive
CMS finalizes notice on Medicare coverage for breakthrough devices
Through the new pathway, called Transitional Coverage for Emerging Technologies, the CMS will consider five medical device candidates yearly for national coverage.
By Elise Reuter • Aug. 8, 2024 -
Courtesy of Nevro
Nevro considers sale as competition for pain market ramps up
CEO Kevin Thornal told investors Nevro felt “an urgency” to respond to a market that is being reshaped by direct and indirect competition.
By Nick Paul Taylor • Aug. 8, 2024 -
Permission granted by Medtronic
Abbott, Medtronic partner on diabetes tech
Abbott will develop a glucose sensor that can only connect with Medtronic's insulin delivery technology.
By Elise Reuter • Aug. 7, 2024 -
Bruce Bennett via Getty Images
Henry Schein’s slow recovery from cyber incident hits Q2 results
William Blair analysts said the “lingering impacts from the cyberattack are somewhat surprising.”
By Nick Paul Taylor • Aug. 7, 2024 -
Courtesy of Medtronic
Medtronic recalls nerve monitoring system linked to 10 injuries
Medtronic has asked users to be aware the devices may not alert when on a nerve, which could lead to injuries during surgery.
By Nick Paul Taylor • Aug. 7, 2024 -
Sarah Silbiger via Getty Images
FDA seeks feedback on health equity for medical devices
The agency plans to develop a framework for when devices should be evaluated in diverse populations to support marketing authorization.
By Nick Paul Taylor • Aug. 6, 2024 -
Courtesy of Ascensia Diabetes Care
Q&AAscensia’s new head of CGM talks plans for a 365-day sensor
Brian Hansen recently joined Ascensia, which markets Senseonics’ implantable glucose sensors. The current version lasts 180 days, but Senseonics is seeking FDA approval for a one-year sensor.
By Elise Reuter • Aug. 6, 2024
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