Medical Devices
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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 where the electrode pads were used.
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 -
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 -
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Nearly three years after publishing draft guidance, the FDA has changed the title and added a section on the regulatory requirements for remanufacturers in the final version of the text.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 -
Ramberg via Getty Images
UK sets out position on regulating AI as a medical device
Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.
By Nick Paul Taylor • May 3, 2024 -
Courtesy of Cue Health Press Kit
Cue Health to cut 230 employees
Declining COVID-19 test sales have forced Cue to eliminate hundreds of jobs in multiple rounds of layoffs over the past several years.
By Elise Reuter • May 3, 2024 -
Retrieved from Food and Drug Administration.
Cardinal receives FDA warning letter over unapproved syringes
The agency has recently increased scrutiny of plastic syringes made in China because of safety concerns, including blocking imports from two Chinese manufacturers.
By Elise Reuter • May 2, 2024 -
N/A via Getty Images
Philips reaches major settlements related to respiratory devices recall
A judge recently finalized an economic claims settlement, and Philips said it reached an agreement on medical claims.
By Elise Reuter • May 2, 2024 -
Nastassia Samal via Getty Images
Medline to buy Ecolab’s surgical products for nearly $1B
The medical products supplier will acquire Ecolab’s sterile drapes and fluid temperature management systems.
By Susan Kelly • May 1, 2024 -
Permission granted by Senseonics
Senseonics gets FDA clearance to pair CGM implant with insulin pumps
Analysts said the designation and planned one-year sensor could help Senseonics’ device appeal to more patients.
By Nick Paul Taylor • May 1, 2024 -
Courtesy of Endomagnetics
Hologic to buy Endomagnetics for $310M
Endomagnetics, which makes guidance technology for breast cancer surgery, brought in about $35 million in revenue last year.
By Elise Reuter • April 30, 2024 -
Courtesy of Abbott Laboratories
Abbott wins FDA approval for Esprit resorbable scaffold
While RBC analysts wrote there’s “strong appetite” for the system, BTIG said the need to train centers could result in a gradual launch.
By Nick Paul Taylor • April 30, 2024 -
mathisworks via Getty Images
Medtronic to lay off 44 employees in California
Medtronic’s latest layoff plan adds to what has become a long list of job cuts for the medical device industry this year.
By Ricky Zipp • April 29, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips agrees to $1.1B settlement of US respiratory recall lawsuits
CEO Roy Jakobs said on a first-quarter earnings call that “for the U.S., this is as final as it can get.”
By Nick Paul Taylor • April 29, 2024
