FDA: Page 54
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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 -
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 -
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 -
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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 -
Medtronic's HVAD controversy
12 deaths linked to Class I recall for Medtronic's HeartWare HVAD
The recall was first made public in the FDA's database on April 6. Medtronic provided a different accounting of total patient deaths as of January and said the company is redesigning parts.
By Nick Paul Taylor • Updated April 16, 2021 -
Medtechs top pharma in cash to doctors for consulting, travel: Health Affairs study
The majority of sector payments, also covering royalties, speaking fees and food, came from the likes of Medtronic, J&J, Zimmer, Stryker and Abbott. Specialties targeted included neurosurgery, orthopaedics and cardiology.
By Ricky Zipp • April 6, 2021 -
UCLA engineer calls for mitigation of biases of medical devices
The perspective in the journal Science comes as the FDA has warned of social biases in data used to train artificial intelligence and bias against Black patients using pulse oximeters.
By Nick Paul Taylor • April 5, 2021 -
Jacob Bell/MedTech Dive
FDA warns of patient deaths tied to reusable urological endoscopes
The agency is sounding the alarm after receiving more than 450 adverse event reports in four years tying patient infections to the devices. Products from Olympus and Karl Storz were cited in the reports.
By Susan Kelly • Updated April 5, 2021 -
Liquid biopsies dominate FDA's latest breakthrough device nods
Cancer tests feature heavily in the latest round of agency breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status.
By Nick Paul Taylor • April 5, 2021 -
FDA links certain breast reconstruction devices to risk of complications
The analysis found Becton Dickinson's AlloMax and MTF's FlexHD may have higher major complication rates than devices made by companies including AbbVie's Allergan.
By Nick Paul Taylor • April 1, 2021 -
Jacob Bell/MedTech Dive
Abbott, BD, Quidel tests get EUAs for asymptomatic COVID-19 serial screening
While the Abbott and Quidel authorizations are for over-the-counter use, BD's test requires a prescription, which "along with the fact an instrument is needed, limits the use-cases for the company significantly," William Blair analysts wrote.
By Greg Slabodkin • April 1, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
FDA updates impact of mutations on COVID-19 tests, adds Cepheid to list of affected products
A new agency webpage features the latest information about the potential impact of viral mutations on molecular diagnostics such as Cepheid's Xpert line of rapid SARS-CoV-2 tests.
By Nick Paul Taylor • March 31, 2021 -
FDA panel to probe Endologix, broader stent graft safety in November
An advisory panel will meet for two days as the agency mulls further action to address blood leak risks with the medtech's grafts for abdominal aortic aneurysms, and surveillance strategies for all AAA endovascular grafts.
By Susan Kelly • Updated Aug. 26, 2021 -
Helius gets FDA nod for neuromodulator after pivoting to multiple sclerosis
The non-implantable device delivers neuromuscular stimulation to an MS patient's tongue, sending electrical signals to the central nervous system as a short-term treatment of gait deficit.
By Nick Paul Taylor • March 29, 2021
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