FDA: Page 53
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Deep Dive
Medtronic HeartWare system hit with slew of Class I recalls, device reports since 2012 PMA
The pump has a higher rate of malfunction reports than rivals, according to an ECRI analysis of the FDA's MAUDE database. But it's hard to draw conclusions from a disparate system of safety reporting.
By Ricky Zipp • May 21, 2021 -
FDA 'working around the clock' with COVID-19 workload, all reviews impacted: CDRH chief
Jeff Shuren said Wednesday the agency might miss some Medical Device User Fee Amendments performance goals for PMA applications and 510(k) submissions.
By Greg Slabodkin • May 20, 2021 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Sarah Silbiger via Getty Images
Guidance on safety testing, labeling of devices in MR environments finalized by FDA
The agency kept the structure of the draft but changed many details about how medical device developers should test their products.
By Nick Paul Taylor • May 20, 2021 -
Sean Gallup via Getty Images
FDA opposes COVID-19 antibody testing to assess post-vaccination immunity
The warning comes as some medtechs bet on the tests. Beckman Coulter unveiled a fully quantitative one just as the agency issued the safety notice.
By Nick Paul Taylor • May 20, 2021 -
Courtesy of Exact Sciences
US panel trims colorectal cancer screening age, opens door to annual Cologuard use
William Blair said the recommendations are a positive for Exact Sciences, which has framed the guidance as a chance to drive growth by targeting 19 million people in the screening cohort.
By Nick Paul Taylor • May 19, 2021 -
Bayer sees jump in Essure adverse event reports gleaned from social media
Most are based on online posts made from 2014 to 2016. The company, which pulled the birth control implant from the U.S. market in 2018, attributed the surge to fewer source documents giving it more time to complete each report.
By Nick Paul Taylor • May 18, 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 -
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 -
Alex Wong via Getty Images
Providers supportive of push to overhaul HIPAA, but air serious concerns about data privacy, timing
"We urge OCR to reconsider implementing a massive change to patient privacy laws in the midst of this transition," AMA commented on the Trump-era rule.
By Rebecca Pifer Parduhn • May 11, 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
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 -
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 -
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 -
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 -
Q&A
Radiology 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 -
CMS finalizes joint replacement pricing extension with input from medtech industry
Cowen analysts say the agency's initiative could evolve in ways that put pressure on the prices of orthopaedic devices. However, they contend companies can mitigate that threat by selling more products to customers.
By Nick Paul Taylor • April 30, 2021 -
CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices
Boston Scientific's Eluvia drug-eluting stent, Cook Medical's Hemospray and Stryker's SpineJack system are among those that would get the extension under the proposed fiscal 2022 inpatient hospital rule.
By Nick Paul Taylor • April 28, 2021 -
Abbott
Abbott, Quest look to post-pandemic home testing beyond COVID-19
With development of at-home coronavirus tests, the companies see opportunities for over-the-counter and direct-to-consumer diagnostics for other diseases and conditions, from respiratory ailments to cancer.
By Greg Slabodkin • April 27, 2021 -
Hospital margins remain narrow in March as COVID-19 financial strain lingers
Pandemic-related costs continue to depress health system finances, though performance recuperated as outpatient activity increased, Kaufman Hall found.
By Rebecca Pifer Parduhn • April 27, 2021 -
Permission granted by Biogen
FDA greenlights device to retrain muscles in stroke patients
The noninvasive brain-computer interface technology uses data from the uninjured side of a patient's brain to recover motor function in the affected arm and hand.
By Susan Kelly • April 26, 2021 -
Alex Wong via Getty Images
Value-based care at 'critical juncture,' new CMMI chief says
Even though some testing payment models have been delayed or discarded, the new leader of CMS' innovation arm said the agency remains committed to finding models that reward value over volume.
By Rebecca Pifer Parduhn • April 23, 2021
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