Medical Devices: Page 29
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Retrieved from Hologic on May 23, 2024
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.
By Nick Paul Taylor • May 23, 2024 -
Courtesy of Cue Health Press Kit
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.
By Elise Reuter • May 22, 2024 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Courtesy of Tandem Diabetes Care
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.
By Elise Reuter • May 22, 2024 -
Carl Court via Getty Images
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.
By Nick Paul Taylor • May 22, 2024 -
Courtesy of H2O Therapeutics
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.
By Elise Reuter • May 21, 2024 -
Courtesy of Medtronic
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.
By Nick Paul Taylor • May 21, 2024 -
Courtesy of Boston Scientific
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.
By Nick Paul Taylor • May 21, 2024 -
Courtesy of Medtronic
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.
By Susan Kelly • May 20, 2024 -
Courtesy of Boston Scientific
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.
By Nick Paul Taylor • May 20, 2024 -
Courtesy of Johnson & Johnson
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.
By Nick Paul Taylor • May 20, 2024 -
Getty Images via Getty Images
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.
By Nick Paul Taylor • May 17, 2024 -
Sara Silbiger via Getty Images
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.
By Nick Paul Taylor • May 17, 2024 -
Permission granted by Becton Dickinson
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.
By Nick Paul Taylor • May 17, 2024 -
Courtesy of Dexcom
Dexcom details plans for over-the-counter CGM as insulin pump firms seek Type 2 coverage
Diabetes tech companies shared updates on new products, largely focused on Type 2 patients, in Q1 earnings calls.
By Elise Reuter • May 16, 2024 -
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 -
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
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