Medical Devices: Page 96
-
Courtesy of Boston Scientific
Boston Scientific's Watchman shows low stroke rate in large registry at ACC
The fast-growing product performed well in an analysis of more than 36,000 people presented at the American College of Cardiology meeting, with low adverse event rates that surprised even the study's author.
By Susan Kelly • May 17, 2021 -
Sarah Silbiger via Getty Images
Paclitaxel, uncoated stents for PAD show similar mortality in real world study
The review of outcomes for Medicare beneficiaries contrasts a 2018 meta-analysis that identified a mortality signal for patients treated with drug-coated stents and balloons. Still, JAMA editors said mortality rates are troublingly high.
By Susan Kelly • May 17, 2021 -
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 -
Edwards tricuspid valve replacement cut leakage for 98% of participants in early trial results
A total of 56 patients were examined 30 days after a transcatheter tricuspid valve replacement procedure. Edwards now plans to start a pivotal trial, examining the procedure in 775 patients.
By Ricky Zipp • May 17, 2021 -
artJazz via Getty Images
Sponsored by Reed TechWhat is EUDAMED and Basic UDI-DI?
Learn more about Basic UDI-DI, unique to EUDAMED and on the radar of medical device manufacturers.
May 17, 2021 -
Alex Wong via Getty Images
CMS again delays breakthrough device payment rule in nod to skeptics
The agency acknowledged MCIT "could be problematic" in ensuring devices demonstrate value without additional risks for Medicare beneficiaries, depriving industry for now of a long-sought policy goal.
By Nick Paul Taylor • May 17, 2021 -
Sean Gallup via Getty Images
Magnets in Apple, Microsoft devices can interfere with implanted cardioverter defibrillators: study
The Swiss study assessed ICDs that were not implanted in patients, but researchers warned patients with implants to keep electronic devices at least one inch from their chest to prevent dangerous magnetic interactions.
By Greg Slabodkin • Updated March 1, 2022 -
Courtesy of Abbott
Abbott's Assurity, Endurity pacemakers recall dubbed Class I event by FDA
Attributed to moisture, the fault could prevent the devices from delivering pacing, causing an irregular heartbeat and shortness of breath. Abbott has received reports of 135 injuries but no deaths.
By Nick Paul Taylor • Updated May 19, 2021 -
Stefani Reynolds / Stringer via Getty Images
Lawmakers, industry urge CMS to push breakthrough payment rule as May 15 deadline looms
Amid speculation of another delay, Democrats in Congress wrote to acting CMS administrator Liz Richter voicing support for the Medicare Coverage for Innovative Technology rule.
By Nick Paul Taylor • May 13, 2021 -
Diabetes tech companies continue 2020's success with Q1 growth. Investors seem unimpressed.
Dexcom, Insulet and Tandem all grew revenue or sales in Q1, winning over Wall Street analysts but seemingly not investors. Meanwhile, the diabetes tech space grows with FDA's clearance of Bigfoot Biomedical's smart insulin pen.
By Ricky Zipp • May 12, 2021 -
Lintao Zhang / Staff via Getty Images
EU plans to impose additional regulations on medtech AI products, other 'high-risk' systems
The proposed legal framework, which addresses potential artificial intelligence risks, seeks to regulate the technology and issue fines for noncompliance that could total billions of dollars, positioning Europe for a leading AI role globally.
By Nick Paul Taylor • May 12, 2021 -
Medtronic's HVAD controversy
Medtronic hit with another Class I recall regarding HeartWare HVAD system
The recall for instructions and patient manuals marks the system's third Class I recall in 2021 and fifth since 2018. One death and 64 injuries have been reported due to issues from the most recent recall.
By Ricky Zipp • May 12, 2021 -
OIG calls on EPA to review ethylene oxide cancer risks, possibly delaying new regulations until 2022
The Office of Inspector General wants the agency to conduct a fresh review of cancer risks from EtO emissions associated with medical device sterilization facilities. EPA's final commercial sterilizer rule had been slated for 2021.
By Susan Kelly • May 11, 2021 -
Alex Wong via Getty Images
FTC asks Allergan Aesthetics, Soliton for additional information on proposed $550M buyout
The regulator's second request for documentary material, which comes three months after the proposed deal was announced, is part of a deeper probe than its standard review of M&A.
By Nick Paul Taylor • Updated Aug. 11, 2021 -
Alex Wong via Getty Images
CMS implementation of breakthrough payment rule may be further delayed: Cowen
The agency will most likely push the start date back further to address the concerns of critics of the contentious Medicare Coverage of Innovative Technology initiative, an analyst contends.
By Nick Paul Taylor • May 10, 2021 -
Courtesy of Boston Scientific
TAVR readmission rates vary widely between hospitals for unknown reasons: study
Length of stay and discharge disposition only explained 15% of the inter-hospital variation. The study's authors have called for efforts to identify practices associated with low rates or readmission.
By Nick Paul Taylor • May 10, 2021 -
Fotolia
Robotic surgery outlook boosted by hospital spending pickup in Q1
Intuitive and Stryker said that system buys were stronger than expected in the first quarter. Zimmer also reported momentum for its Rosa system, while Globus had positive early feedback for its robotic spine technology.
By Susan Kelly • May 10, 2021 -
Morris MacMatzen / Stringer via Getty Images
With MDR nearing, EU updates guidance on transition to Eudamed database
The European Union no longer requires reporting obligations to be carried out as soon as the database becomes fully functional. The Medical Device Regulation takes effect May 26 and Eudamed will come online one year later.
By Nick Paul Taylor • May 7, 2021 -
Permission granted by iRhythm Technologies
iRhythm again meets with Medicare rate setter after cardiac monitoring pay cut by nearly $200
CEO Michael Coyle said during a Thursday earnings call the company has met with Novitas Solutions to discuss a different pricing methodology. Investors seemed encouraged as shares were up nearly 8% Friday morning.
By Ricky Zipp • May 7, 2021 -
Jacob Bell
FDA shares plan for restarting facility inspections, warns backlog will persist into 2022
In a projected base-case scenario, the agency expects to have cleared 26% of its backlog of medical product inspections by October. A total of 2,426 device and radiological health inspections remain for fiscal year 2021.
By Nick Paul Taylor • May 7, 2021 -
Dollar Photo Club
Nevro raises outlook as neuromodulation market recovers from COVID-19 crisis
Improvements during the quarter, which culminated in Nevro's best March ever, emboldened the company to target at least 22% growth in 2021. Still, the company's stock price dropped by about 6% Thursday morning.
By Nick Paul Taylor • May 6, 2021 -
Courtesy of BD/PRNewswire
BD grows Q2 revenue despite COVID-19 test dip, spins off diabetes business
The spin off for the separate publicly traded company is expected to be completed in the first half of calendar year 2022. The move will not impact BD's ability to fulfill orders related to COVID-19 vaccinations, execs said.
By Greg Slabodkin • May 6, 2021 -
Sarah Silbiger via Getty Images
AI, digital health feature in latest batch of FDA breakthrough device designations
The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.
By Nick Paul Taylor • May 5, 2021 -
Newer TAVR devices linked to lower rate of permanent pacemaker use: study
The 1,987-subject study found patients receiving older transcatheter heart valves, such as Edwards Lifesciences' Sapien and Medtronic's CoreValve, required permanent pacemakers at a higher rate than newer-generation THVs.
By Nick Paul Taylor • May 5, 2021 -
Zimmer sees Q1 sales growth after CEO warned of down quarter
Bryan Hanson cautioned in February the quarter would be more challenging than the fourth due to COVID-19 pressures. The turnaround led the company to issue full-year 2021 guidance, but investors weren't impressed.
By Ricky Zipp • May 4, 2021 -
Getty
Q&ARadiology Partners, Aidoc talk AI adoption, handling bias, FDA actions
While AI and machine learning technologies have gained popularity in the medtech and healthcare industries, the companies intend to further grow usage in radiology with their recent partnership.
By Ricky Zipp • May 3, 2021
Previous
