Medical Devices: Page 43
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GE HealthCare cuts formaldehyde levels in neonatal incubators with revised process
The FDA previously alerted healthcare providers to the potential for neonatal incubators to emit airborne chemicals.
By Nick Paul Taylor • Oct. 17, 2023 -
Elise Reuter/MedTech Dive
FDA: ‘We have had a very loud voice’ on EtO
The agency said it is working closely with the Environmental Protection Agency, which is slated to implement a final rule in March limiting ethylene oxide emissions for medical device sterilizers.
By Elise Reuter • Oct. 16, 2023 -
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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
Courtesy of BusinessWire/Masimo
Masimo wins de novo authorization for measure of high blood oxygen levels
The ORi device is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation.
By Nick Paul Taylor • Oct. 16, 2023 -
Mario Tama via Getty Images
J&J receives 510(k) clearance for foot fixation device, targets growing bunion market
The clearance comes shortly after Stryker introduced a minimally invasive system for treating bunions.
By Nick Paul Taylor • Oct. 16, 2023 -
ArtemisDiana via Getty Images
FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024
The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.
By Nick Paul Taylor • Oct. 13, 2023 -
peakSTOCK via Getty Images
GE HealthCare wins $44M BARDA contract to develop AI-enabled ultrasound
BARDA sees challenges with using ultrasound in trauma care, leading it to task GE HealthCare with developing an automated 4D system and AI algorithms.
By Nick Paul Taylor • Oct. 13, 2023 -
European Commission orders Illumina to divest Grail
The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.
By Susan Kelly • Oct. 12, 2023 -
Steve Geer via Getty Images
Top medtech conferences remaining in 2024
With several key conferences already wrapped, some of the biggest industry events left this year include the American Diabetes Association’s 84th Scientific Sessions and Advamed’s annual meeting.
By Susan Kelly • Updated June 3, 2024 -
Courtesy of Abiomed/J&J
J&J’s Abiomed hit with FDA warning letter over Impella heart pump
The letter identifies quality system problems in a group of recalled devices and says monitoring software used with the pump requires premarket authorization.
By Susan Kelly • Oct. 12, 2023 -
Sarah Silbiger via Getty Images
Boston Scientific wins diabetic neuropathy approval, joining rivals in growing market
The expanded indication positions Boston Scientific to challenge Abbott, Medtronic and Nevro for the emerging opportunity in spinal cord stimulation to treat the condition.
By Nick Paul Taylor • Oct. 12, 2023 -
Natalie Meepian via Getty Images
Getinge inks $320M Healthmark takeover to bolster US sterile reprocessing capabilities
Buying Healthmark strengthens the position of Getinge in the U.S., building on two recent acquisitions of sterile reprocessing technology.
By Nick Paul Taylor • Oct. 12, 2023 -
Elise Reuter/MedTech Dive
How Medtronic, Zimmer Biomet and Smith & Nephew are thinking about acquisitions, spinoffs
Executives from the three medical device firms said they expect more deal-making in the long term, but face tough discussions about valuations with targets.
By Elise Reuter • Oct. 11, 2023 -
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Haemonetics inks $253M OpSens buyout, adding cardiology guidewires to portfolio
The takeover will give Haemonetics devices that complement its vascular closure products, analysts said.
By Nick Paul Taylor • Oct. 11, 2023 -
Elise Reuter/MedTech Dive
5 financial challenges facing the medtech sector: EY
Declining stock prices, M&A, investment and revenues are dogging the industry in a difficult year, according to a new report from the consulting firm.
By Elise Reuter • Oct. 10, 2023 -
Courtesy of HistoSonics
J&J-backed HistoSonics gets de novo clearance for liver cancer treatment
The system offers a minimally invasive alternative to surgical resection and thermal ablation in patients with primary and metastatic liver cancers.
By Nick Paul Taylor • Oct. 10, 2023 -
Elise Reuter/MedTech Dive
Clinicians ‘love yet fear’ AI, say medtech leaders
Stryker, Siemens Healthineers and Google execs said at the MedTech Conference that digital technology can help with patient care, but healthcare professionals also worry about it taking their jobs.
By Elise Reuter • Oct. 10, 2023 -
Retrieved from Insulet v. EOFlow et. al. on August 15, 2023
Insulet wins preliminary injunction against EOFlow in patent suit
A federal judge has blocked EOFlow, a company that Medtronic plans to acquire, from selling its insulin patch pump.
By Susan Kelly • Oct. 9, 2023 -
Mario Tama via Getty Images
J&J could reach market-leading medtech growth after consumer spinoff: analysts
The analysts identified J&J’s leadership position in 11 categories, shift to fast-growing markets and investment in robotics as strengths.
By Nick Paul Taylor • Oct. 9, 2023 -
Daphne Howland/MedTech Dive
Best Buy to sell continuous glucose monitoring systems
It’s the tech retailer’s first foray into prescription-based medical device sales.
By Rebecca Pifer • Oct. 9, 2023 -
Courtesy of Philips
FDA says Philips’ testing of recalled devices is inadequate
The regulator called for further tests to evaluate health risks posed to patients from the sound abatement foam used in the devices.
By Elise Reuter • Oct. 6, 2023 -
Permission granted by GE HealthCare
Q&AGE HealthCare imaging CEO Jan Makela talks Mayo Clinic partnership
GE and Mayo Clinic plan to collaborate on imaging, artificial intelligence and cancer treatment.
By Elise Reuter • Oct. 6, 2023 -
magicmine via Getty Images
Catheter ablation beats drugs in J&J retrospective study of AFib heart failure risk
Patients who received catheter ablation had a 57% lower risk of developing heart failure than their counterparts on antiarrhythmic drugs.
By Nick Paul Taylor • Oct. 6, 2023 -
Permission granted by Medtronic
Medtronic hires neuromodulation president from Smith+Nephew
Paolo Di Vincenzo will oversee strategy and operations for pain interventions and brain modulation.
By Susan Kelly • Oct. 5, 2023 -
Retrieved from Medtronic on October 05, 2023
Medtronic posts warning after stolen, defective intubation devices advertised for sale
The notice covers McGrath MAC video laryngoscopes that were designated for destruction and never released for sale.
By Nick Paul Taylor • Oct. 5, 2023 -
libre de droit via Getty Images
Akura Medical secures $35M to pursue FDA clearance for thrombectomy device
The money also will help fund clinical trials for additional indications and the expansion of its manufacturing capabilities.
By Susan Kelly • Oct. 4, 2023
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