The Latest
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Tracker
Tracking Philips Respironics recalls
Philips issued two recalls after finding a software malfunction could affect BiPAP ventilators and a machine for sleep apnea studies.
Updated May 30, 2024 -
Medtronic elevates Linnea Burman to president of neurovascular unit
Burman will oversee strategy, product development and financial performance for a unit focused on stroke care.
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Otsuka defies digital health downturn with new company
With “no playbook out there” to fall back on, the new company is taking a long-term approach as it develops its portfolio, an Otsuka Precision Health exec told MedTech Dive.
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Q&A
J&J’s Nisha Johnson on Ethizia wound-sealing patch, biosurgery market
With the recent launch of the hemostatic healing patch in Europe, J&J expects to lead the biosurgery and wound closure market.
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New products take center stage in medtech’s latest earnings season
From pulsed field ablation devices to Intuitive's latest da Vinci robot, product launches dominated recent earnings calls.
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More than a third of healthcare organizations aren’t prepared for cyberattacks: report
Thirty-seven percent of healthcare organizations did not have a cyberattack contingency plan in place, despite half having experienced an attack, according to a new survey from Software Advice.
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FDA panel backs Guardant’s blood test for colon cancer
“The favorable panel vote does not by any means imply this test will become an overnight success,” wrote William Blair analyst Andrew Brackmann.
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Medline, Chinese manufacturer launch recalls for plastic syringes
Medline and Jiangsu Shenli Medical Production are at the center of the FDA’s probe of plastic syringes made in China.
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UK regulator proposes recognizing overseas medical device approvals
Companies with authorization in certain regions, including the EU and U.S., would be able to use their approvals to access Great Britain’s market.
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Medtronic touts demand for PFA, adding to hype for the new ablation tech
CEO Geoff Martha told investors there has already been “strong adoption” of PFA devices and the category will be a big part of Medtronic's revenue growth in fiscal year 2025.
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Hologic recalls more than 53,000 radiographic markers linked to 71 injuries
The Biozorb devices are staying on the market, but Hologic has asked people to report adverse events such as pain.
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Cue Health to lay off remaining employees, shut down
Once a COVID-testing darling, Cue will close after raising hundreds of millions of dollars and striking high-profile partnerships with Google and the NBA during the pandemic.
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Medicare adviser sets recommendations for diabetes device evidence
A MEDCAC panel found time in range was an “extremely important” metric, but members were divided on whether quality of life measures should influence coverage.
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Guardant colon cancer test struggles to detect non-cancerous tumors, FDA says
Agency scientists highlighted the risk in materials posted ahead of a Thursday advisory panel meeting for the Guardant Health blood test.
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EMA updates advice on drug-device combinations under MDR, IVDR
The European Medicines Agency answered six new questions to clarify topics such as how companies can get advice on borderline products.
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FDA seeks AI tech to predict, detect Parkinson’s symptoms
By testing artificial intelligence and machine learning models, the agency hopes to come up with best practices for Parkinson’s measures from wearables and smartphones.
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Medtronic heads into earnings having seen rivals prosper
J.P. Morgan and RBC analysts are expecting updates on several key markets on Medtronic's Q4 call, including surgical robotics and pulsed field ablation.
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Boston Scientific’s cardiac rhythm system hits pivotal trial goals
Boston Scientific, which presented the results at the Heart Rhythm Society meeting, expects to receive FDA approval for the system in 2025.
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Pulsed field ablation poised for fast adoption, analysts say
Feedback from the Heart Rhythm Society meeting suggests 50% to 70% of physicians could adopt the procedure “right out of the gate,” said Truist analyst Richard Newitter.
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J&J posts latest Varipulse data while awaiting FDA review
Johnson & Johnson is chasing Medtronic and Boston Scientific in the U.S. for a share of the rapidly growing pulsed field ablation market.
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UK backs use of cancer treatment offered by Boston Scientific
A Boston Scientific executive said the guidance will expand access to a minimally invasive treatment for tumors that have metastasized to the liver.
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FDA issues import alerts against 2 more plastic syringe manufacturers
Officials moved to stop the plastic syringes made by two Chinese manufacturers from entering the U.S. after finding quality system failings.
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Pulse Biosciences names new CEO, reassigns former leader
Burke Barrett will take over the role effectively immediately, while former CEO Kevin Danahy will become the chief commercial officer.
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BD wins FDA approval for cervical cancer screening self-collection kit
Patients can self-collect the samples in locations such as retail pharmacies, which could encourage more people to get tested.
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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.