Medical Devices: Page 7
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Courtesy of Dexcom
Dexcom prices first over-the-counter glucose monitor
Known as Stelo, the device is intended for people who don’t take insulin and costs $89 per month.
By Elise Reuter • Aug. 26, 2024 -
Sarah Silbiger via Getty Images
FDA seeks feedback on predetermined change control plans
The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.
By Nick Paul Taylor • Aug. 26, 2024 -
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Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
Sarah Silbiger via Getty Images
Defibtech recalls chest compression device linked to patient death
Customers are asked to return affected devices due to a problem in the motor that could stop compressions.
By Nick Paul Taylor • Aug. 26, 2024 -
Retrieved from Stryker on August 23, 2024
Stryker to add back pain treatment with Vertos Medical buy
Stryker’s latest purchase comes amid a pickup in medtech M&A, with Johnson & Johnson, Boston Scientific and Edwards Lifesciences all active this year.
By Susan Kelly • Aug. 23, 2024 -
Courtesy of Procept Biorobotics
Procept wins FDA clearance for updated prostate surgery robot
Procept Biorobotics has added AI capabilities and switched to a single-use scope to support mass-market adoption.
By Nick Paul Taylor • Aug. 22, 2024 -
Avosb via Getty Images
Zoll to buy Vyaire’s ventilator business with $37M auction bid
Vyaire Medical held a virtual auction of assets after filing for Chapter 11 bankruptcy protection in June.
By Nick Paul Taylor • Aug. 21, 2024 -
"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 -
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
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