Medical Devices: Page 54
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Permission granted by Urologic
Urotronic wins FDA approval to challenge Boston Scientific, Teleflex for prostate market
The company’s Optilume device combines balloon dilation and the delivery of paclitaxel to treat symptoms linked to an enlarged prostate.
By Nick Paul Taylor • July 13, 2023 -
artJazz via Getty Images
Illumina hit by EU with maximum €432M fine for Grail acquisition
The European Commission called Illumina’s closing of the deal without its approval an “unprecedented” move that undermines its system for regulating the competitive landscape.
By Susan Kelly • July 12, 2023 -
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
Tandem’s Mobi insulin pump could reaccelerate growth next year: analyst
The device, which is smaller than Tandem’s past pumps, could drive more people to switch from insulin injections, an analyst with Craig-Hallum said.
By Elise Reuter • July 12, 2023 -
Courtesy of U.S. Food and Drug Administration
Analysis shows paclitaxel-coated devices unlikely to increase death risk, leading FDA to withdraw warning
The FDA’s decision to remove mortality warnings from device labels is a boost to manufacturers of paclitaxel-coated devices.
By Nick Paul Taylor • July 12, 2023 -
Sara Silbiger via Getty Images
J&J Megadyne unit’s electrode pad recall labeled Class I over burn risk
The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths.
By Nick Paul Taylor • July 12, 2023 -
Courtesy of Fresenius Medical Care
Fresenius Medical Care names Martin Fischer as CFO
Fischer joins the company after former CFO Helen Giza was promoted to CEO.
By Elise Reuter • July 11, 2023 -
Permission granted by ShockWave
Analysts expect a reimbursement boost for Shockwave coronary artery-clearing device
The analysts think growth expectations for the company are too low and have set their earnings estimate for next year 15% above Wall Street’s consensus.
By Nick Paul Taylor • July 11, 2023 -
Courtesy of Masimo
Masimo’s board turnover could bring Sound United spinoff, analysts say
Needham analysts say that new voices on the patient-monitoring company’s board, after a proxy battle, could catalyze the sale of the audio unit, even as Masimo pursues its consumer healthcare strategy.
By Susan Kelly • July 11, 2023 -
Portra via Getty Images
Automated machine learning model identifies patients at risk for surgical complications
The model outperformed the established calculator of surgical risk and requires less input from clinicians.
By Nick Paul Taylor • July 11, 2023 -
Courtesy of Outset Medical
Outset Medical receives warning letter related to dialysis device
The warning letter claims Outset Medical made assertions outside of the current indications for its Tablo dialysis system and needs clearance for a device accessory.
By Elise Reuter • July 10, 2023 -
Natalie Meepian via Getty Images
Coloplast to pay $1.2B upfront to buy fish skin wound care business Kerecis
Kerecis’ fish skin biologic, which aids tissue regeneration, helped drive the company’s sales to $74.5 million last year.
By Nick Paul Taylor • July 10, 2023 -
Permission granted by Medtronic
Medtronic secures Medicare coverage for MiniMed 780G insulin pump
Medtronic has begun processing orders and will start shipping devices over the next few weeks.
By Nick Paul Taylor • July 10, 2023 -
Permission granted by Penumbra
Q&AQ&A: Penumbra CEO Adam Elsesser says new devices will drive changes in clot treatment
Penumbra has launched two devices that use computers to control suction of blood clots. That’s helped the company convert some surgeons from traditional methods of clot removal, like open surgery or drugs.
By Elise Reuter • July 7, 2023 -
Permission granted by Becton Dickinson
BD to shed 60 jobs as COVID demand, diabetes spinoff affect manufacturing plant
The cuts are the latest in a wave of workforce reductions by medtech companies including Abbott Laboratories, Cook Medical, Illumina and Thermo Fisher Scientific.
By Nick Paul Taylor • July 7, 2023 -
Sean Gallup / Staff via Getty Images
Illumina’s ‘inevitable’ split from Grail likely by mid-2024, analysts say
Canaccord Genuity analysts, commenting on a Financial Times article predicting a record EU fine against the DNA sequencer for closing its Grail acquisition, said it looks “almost certain” regulators will force a divestiture.
By Susan Kelly • July 6, 2023 -
Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
FTC intervenes to correct Medtronic’s ‘erroneous assertions’ in antitrust case
The FTC filed an amicus brief because it said Medtronic made “wrong” arguments with “broad implications for antitrust enforcement.”
By Nick Paul Taylor • July 6, 2023 -
Adam Berry via Getty Images
European guidelines offer support for renal denervation in hypertension, boosting Medtronic, ReCor
Medtronic hailed the updated guidelines as a “turning point” for the use of renal denervation in treating high blood pressure.
By Nick Paul Taylor • July 6, 2023 -
solarseven via Getty Images
Medtronic identifies cybersecurity vulnerability in cardiac data system
Cyber attackers could exploit the vulnerability if healthcare organizations have enabled its optional messaging service, the device maker said.
By Susan Kelly • July 5, 2023 -
Courtesy of Abbott
Abbott secures FDA approval for dual-chamber leadless pacemaker
With the new device, Abbott is ramping up competition with Medtronic in the leadless pacemaker market.
By Elise Reuter • July 5, 2023 -
Courtesy of U.S. Food and Drug Administration
Startup’s fast-acting wound treatment gel gets FDA nod for use in humans
Cresilon raised $25 million last year as part of a push to expand its wound-gel product for animals into human health.
By Nick Paul Taylor • July 5, 2023 -
Courtesy of Dexcom
Q&AQ&A: Dexcom’s Lawver shares strategy behind CGM for non-insulin users
The continuous glucose monitor in development for people with Type 2 diabetes who don’t take insulin could expand the CGM market to 25 million more people in the U.S., the company’s new chief commercial officer said.
By Elise Reuter • June 30, 2023 -
Mario Tama via Getty Images
Diabetes remains fastest-growing medtech market despite some risk from new drugs: analysts
The medicines could apply “short-lived pressures” to medtech companies by affecting the use of insulin, Mizuho analysts say.
By Nick Paul Taylor • June 30, 2023 -
artJazz via Getty Images
EU MDR costs could cause device shortages for children, medical groups warn
The cost of certification under new medical device regulations in Europe is a barrier to manufacturers that make devices for small groups of patients, medical associations said.
By Elise Reuter • June 29, 2023 -
Retrieved from Istock.
FDA seeks feedback on technologies that can enable healthcare at home
The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.
By Nick Paul Taylor • June 29, 2023 -
Sarah Silbiger via Getty Images
FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use
The agency in March cleared NuVasive to market its Precice limb-lengthening system for use in the femur and tibia of children aged 12 years and up.
By Nick Paul Taylor • June 29, 2023
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