Medical Devices: Page 23
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Courtesy of Getinge
Getinge to limit US sales of heart devices after FDA safety warning
CEO Mattias Perjos said the action will have “some negative financial impact,” but the total effect will depend on customers' response.
By Nick Paul Taylor • May 16, 2024 -
Maks_Lab via Getty Images
Stereotaxis inks APT buyout to gain catheters for surgical robots
The partners are developing a robotically steered diagnostic catheter for use with Stereotaxis’ cardiovascular robots.
By Nick Paul Taylor • May 16, 2024 -
Explore the Trendlineâž”
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 -
Courtesy of Boston Scientific
Boston Scientific recalls more than 1M angiographic catheters
Hospitals should discontinue use of the devices and return them due to potential safety risks, Boston Scientific wrote in a March letter to customers.
By Susan Kelly • May 15, 2024 -
Courtesy of Abbott
Abbott recalls Heartmate pump after 70 injuries, 2 deaths reported
In the latest notice, which follows a February recall of the device for a separate issue, Abbott took action due to reports of blood leakage and air entrapment.
By Susan Kelly • Updated May 16, 2024 -
Courtesy of Simon Dawson / 10 Downing Street
Siemens Healthineers invests $314M in new MRI manufacturing plant
Siemens said the facility will support 1,300 jobs, including the more than 600 people it currently employs in the area.
By Nick Paul Taylor • May 15, 2024 -
Stringer via Getty Images
GE Healthcare warns of cybersecurity risks in ultrasound devices, software
Cybersecurity group Nozomi Networks Labs identified 11 vulnerabilities across several systems and software in an investigation of imaging machines.
By Nick Paul Taylor • May 15, 2024 -
Nick van Bree via Getty Images
US hikes tariffs on medical products from China
The rate increases will apply to equipment including syringes, face masks and surgical gloves.
By Elise Reuter • Updated May 14, 2024 -
Courtesy of Pacific Biosciences
Pacific Biosciences to lay off 195 employees as part of cost cuts
More than half of the job losses stem from the closure of the genome sequencer’s San Diego office amid an ongoing industry slump.
By Susan Kelly • May 14, 2024 -
deberarr via Getty Images
FDA targets health inequality by improving at-home devices
Michelle Tarver, an FDA official, said a new program is meant to advance health equity by considering people’s living conditions as part of medical device design.
By Elise Reuter • May 13, 2024 -
Mario Tama via Getty Images
J&J’s Megadyne discontinues pediatric electrode pad after burn reports
Megadyne discontinued the product globally after receiving four reports of patients being burned in procedures when the electrode pads were used.
By Nick Paul Taylor • May 13, 2024 -
Sarah Silbiger via Getty Images
Route 92 catheter recall tied to 2 injuries, 1 death
The affected devices were manufactured by an outside supplier, not Route 92, and had product quality problems.
By Nick Paul Taylor • May 13, 2024 -
Courtesy of BusinessWire/Masimo
Masimo offers Politan a concession to avoid second proxy fight
Activist investor Politan immediately snubbed Masimo’s offer to accept one nominee to its board, insisting two new directors are needed to resolve governance issues at the pulse oximetry specialist.
By Susan Kelly • May 10, 2024 -
Sarah Silbiger via Getty Images
FDA posts final guidance on remanufacturing medical devices
Nearly three years after publishing draft guidance, the FDA has changed the title and added a section on the regulatory requirements for remanufacturers in the final version of the text.
By Nick Paul Taylor • May 10, 2024 -
Retrieved from The Food and Drug Administration.
How stricter EtO regs could shape the medtech industry
In April, the EPA issued a final rule that would limit emissions of ethylene oxide from device sterilizers. The FDA is also taking actions to help reduce emissions of the toxic sterilant.
By Elise Reuter • May 10, 2024 -
Permission granted by Abbott
Q&AAbbott’s Jennifer Jones-McMeans on treating PAD below the knee
Jennifer Jones-McMeans, a leader in Abbott’s vascular unit, discussed the company’s newly approved stent for the tough-to-treat condition in an interview with MedTech Dive.
By Susan Kelly • May 9, 2024 -
Permission granted by Stryker
Surgical robots are ‘gift that will keep on giving,’ ortho firms say
Stryker, Zimmer and Globus reported double-digit sales growth in their robot segments and outlined plans for new products.
By Elise Reuter • May 9, 2024 -
Courtesy of Tandem Diabetes Care
Tandem reports 224 injuries related to faulty insulin pump app
A problem with Tandem’s iPhone app could drain the battery of the connected insulin pump, causing it to power down sooner than expected.
By Nick Paul Taylor • May 9, 2024 -
Courtesy of Getinge
FDA tells providers to stop using Getinge heart devices
After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.
By Nick Paul Taylor • May 9, 2024 -
Courtesy of Samsung
Samsung Medison to buy AI ultrasound company Sonio
Sonio’s software uses deep learning to improve image quality. Its software will remain compatible with all ultrasound machines, the company said.
By Elise Reuter • May 8, 2024 -
Courtesy of Integra
Integra still addressing problems at Boston plant
A third-party audit of the Boston facility identified more issues, forcing Integra to keep Surgimend and Primatrix off the market for the foreseeable future.
By Nick Paul Taylor • May 8, 2024 -
Courtesy of Outset Medical
Outset Medical gets FDA nod for dialysis accessory months after halting sales
Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.
By Elise Reuter • May 7, 2024 -
Courtesy of CMR Surgical
CMR Surgical names new CFO
Shlomi Cohen takes over the role as the surgical robotics company focuses on global expansion and competing with market leader Intuitive Surgical.
By Susan Kelly • May 7, 2024 -
Courtesy of Masimo
Masimo’s at-home baby monitor cleared for use without prescription
A proposed separation of Masimo’s consumer business, which is currently under consideration, would likely include the Stork monitoring system.
By Susan Kelly • May 7, 2024 -
Courtesy of Medtronic
Medtronic wins approval to sell renal denervation device in China
Medtronic expects sales in China of the Symplicity Spyral blood pressure treatment to “be modest in the short-term.”
By Nick Paul Taylor • May 7, 2024 -
Permission granted by Nextbeam
Deep DiveEtO causes cancer. Device sterilizers are scrambling to find alternatives.
No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.
By Elise Reuter • May 6, 2024
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