FDA: Page 55
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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 -
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
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 -
Getty Images
AdvaMed pushes CMS to implement MCIT final rule without further delay
The Medicare agency postponed the proposal from taking effect amid criticism from some doctors and safety groups that it risks promoting device use without rigorous evidence of safety and effectiveness.
By Susan Kelly • April 19, 2021 -
Permission granted by IQVIA
FDA drops 8 medical software functions from oversight
The final rule, issued without notice or comment, brings the software classifications in line with provisions of the 21st Century Cures Act and reflects the agency's current statutory authority.
By Susan Kelly • April 19, 2021 -
BD files new 510(k) submission for troubled Alaris infusion pump
The announcement comes after a spate of software and hardware recalls regarding the Alaris system throughout 2020 and 2021.
By Ricky Zipp • Updated April 26, 2021 -
Photography by Gage Skidmore / Photo Illustration by Kendall Davis/MedTech Dive
FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan
The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.
By Nick Paul Taylor • April 16, 2021 -
EU MDR delay has not made new rules easier to stomach: exec poll
Most of the 115 respondents to the Climedo Health survey said resources and lack of clarity were top challenges, with about a third indicating compliance efforts will cost their company 5% to 10% of annual revenue.
By Ricky Zipp • April 15, 2021 -
FDA authorizes labs for device conformity testing pilot
The accredited laboratories will assess whether medical devices meet consensus standards. None of the initial 53 labs, which include TÜV SÜD and UL, have so far received accreditation for biocompatibility testing.
By Nick Paul Taylor • April 14, 2021 -
Adeline Kon/MedTech Dive
HHS urged to conduct 'vigorous oversight' of hospital price rule after reports of noncompliance
U.S. lawmakers want the secretary to step up oversight of the new requirement for health systems to make prices for procedures like hip and knee replacements available to the public.
By Samantha Liss • April 14, 2021 -
Getty Images
The US paused use of J&J's vaccine. What happens next?
A call by regulators to stop J&J vaccinations won't dramatically disrupt supply in the U.S. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.
By Ned Pagliarulo , Ben Fidler , Jonathan Gardner • April 14, 2021 -
Permission granted by iRhythm Technologies
iRhythm's future hazy after Medicare pricing saga erases 12-month high
Wall Street analysts project the cardiac wearables maker to lose tens of millions of dollars in revenue in coming years, raising questions about the future of the once-hyped market leader.
By Ricky Zipp • April 13, 2021 -
Doubts cast on CPAP efficacy evidence in HHS agency review
A report prepared for the Agency for Healthcare Research and Quality found available studies "mostly" do not support a link between continuous positive airway pressure therapy and long-term, clinically important outcomes.
By Nick Paul Taylor • April 13, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Lucira gets FDA nod for OTC molecular COVID-19 test
The emergency authorization adds to the competition with the agency clearing over-the-counter tests from Abbott and Cue Health in recent months. The $55 per kit price tag is much higher than Lucira's estimate earlier this year.
By Nick Paul Taylor • April 13, 2021 -
Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance
The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions.
By Greg Slabodkin • April 12, 2021 -
Permission granted by iRhythm Technologies
iRhythm shares tank after Medicare rates surprise
CEO Michael Coyle said the wearables company will withdraw its Zio XT cardiac monitor from Medicare fee-for-service segments, adding that he was not optimistic for a reversal.
By Ricky Zipp • April 12, 2021 -
FDA puts Medtronic Valiant Navion stent graft recall in Class I category
The action, which comes amid one patient death in a clinical trial, deprives Medtronic of a source of sales growth. After securing 2018 approval, then-CEO Omar Ishrak talked up the device's potential to drive incremental growth.
By Nick Paul Taylor • April 12, 2021 -
MDMA, surgeons push Medicare to pull back prior authorization rules
The medtech lobby and 39 stakeholders warned CMS that including cervical fusion with disc removal and implanted spinal neurostimulators as new service categories will delay patient access to medically necessary procedures.
By Greg Slabodkin • April 8, 2021
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