The Latest
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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.
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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.
Updated May 16, 2024 -
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.
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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.
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FDA advises against using Cue Health COVID-19 tests, sends warning letter
Agency inspectors found Cue made unauthorized changes to its COVID-19 kits that “reduced the reliability of the tests.”
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US hikes tariffs on medical products from China
The rate increases will apply to equipment including syringes, face masks and surgical gloves.
Updated May 14, 2024 -
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.
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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.
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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.
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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.
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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.
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Q&A
Abbott’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.
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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.
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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.
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J&J’s $13.1B offer for Shockwave vaults to top of medtech M&A list in 2024
Johnson & Johnson’s proposal for Shockwave Medical replaced Boston Scientific’s $3.7 billion offer for Axionics as the priciest medical device deal this year.
Updated May 10, 2024 -
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.
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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.
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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.
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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.
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Geneoscopy wins FDA approval for Labcorp-partnered colon cancer test
Evercore and Cowen analysts expect Colosense to have a limited impact on Exact Sciences’ rival Cologuard test.
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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.
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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.
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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.
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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.
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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.”