Medical Devices: Page 39
-
Permission granted by Medtronic
Medtronic gains FDA approval for extravascular defibrillator
The device to treat abnormal heart rhythms is designed to avoid risks associated with traditional implantable cardioverter defibrillators that have leads running through the veins to the heart.
By Susan Kelly • Oct. 23, 2023 -
Courtesy of Insulet Corp.
Insulet receives FDA clearance for Omnipod 5 iPhone app
The application removes the need for patients with iPhones to carry a separate controller to manage bolus dosing.
By Elise Reuter • Oct. 23, 2023 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Patrik Stollarz / Staff via Getty Images
Philips’ orders fall in Q3, overshadowing sales growth and return to sleep apnea market
CEO Roy Jakobs said during a third-quarter earnings call that there is still “significant demand” for the company’s sleep apnea products.
By Nick Paul Taylor • Oct. 23, 2023 -
VCG / Stringer via Getty Images
Intuitive’s Q3 sales miss estimates as robot leasing, China demand weigh
The robotic surgery leader’s overall procedure growth, however, exceeded market expectations.
By Susan Kelly • Oct. 20, 2023 -
DSCimage for iStock via Getty Images
AdvaMed CEO warns Congress of supply shortages from EtO, PFAS regulations
The trade group leader called for changes to the EPA’s proposals, while a scientist with UCSF said lawmakers should turn to science free of vested financial interests.
By Elise Reuter • Oct. 20, 2023 -
Courtesy of https://www.edwards.com/devices/heart-valves/transcatheter-SAPIEN-3-Ultra
Physicians forecast Edwards’ 5-year data will have limited impact on low-risk TAVR market
Some doctors think TAVR may perform numerically worse but see little impact on the market unless there is a statistically significant result.
By Nick Paul Taylor • Oct. 20, 2023 -
Courtesy of Anumana
Anumana names Boston Scientific veteran Maulik Nanavaty as CEO
Nanavaty has taken up the post after spending 18 years at Boston Scientific, where he held senior roles in interventional cardiology and neuromodulation.
By Nick Paul Taylor • Oct. 20, 2023 -
Courtesy of Edwards Lifesciences
Edwards receives CE mark for tricuspid valve replacement
The company expects to gain U.S. approval late next year.
By Elise Reuter • Oct. 19, 2023 -
Scott Olson via Getty Images
Supply disruptions are delaying surgeries and compromising patient care, survey finds
A patient safety nonprofit used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages.
By Nick Paul Taylor • Oct. 19, 2023 -
Courtesy of Interventional Systems
Interventional Systems gets second 510(k) clearance for miniature robot
The FDA cleared the Micromate system to use CT navigation in procedures such as biopsies and ablations.
By Susan Kelly • Oct. 19, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA finalizes COVID-era guidance, extending flexibility for some remote monitoring devices
The agency shortened its list of devices that can continue to undergo limited modifications without 510(k) filings.
By Nick Paul Taylor • Oct. 19, 2023 -
Courtesy of BD
BD recycles 40,000 pounds of medical waste in circular economy pilot project
The collaborators assessed the feasibility of recycling medical waste such as plastic syringes.
By Nick Paul Taylor • Oct. 18, 2023 -
Courtesy of Abbott
Abbott raises outlook amid strong Q3, sees momentum into 2024
Sales of the FreeStyle Libre continuous glucose monitor rose nearly 31% despite investor worries about the potential impact of weight-loss drugs on demand.
By Susan Kelly • Oct. 18, 2023 -
Spencer Platt via Getty Images
Siemens Healthineers partners to improve tuberculosis screening using AI
The company will work with the Global Fund to Fight AIDS, Tuberculosis and Malaria, providing free licenses and helping to integrate AI-enabled processes into clinicians’ workflows.
By Nick Paul Taylor • Oct. 18, 2023 -
Mario Tama via Getty Images
J&J to restructure orthopedics business
The company announced the two-year restructuring in its third-quarter earnings call. It expects the changes to accelerate growth and enhance profitability, CFO Joe Wolk said.
By Elise Reuter • Oct. 17, 2023 -
Mario Tama / Getty via Getty Images
Medtech can cope with GLP-1s but ‘fear and doubt’ suppressing stocks: analysts
J.P. Morgan analysts caution that stocks could continue to suffer through 2024 and 2025.
By Nick Paul Taylor • Oct. 17, 2023 -
Stock via Getty Images
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 -
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 -
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 -
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
Previous
