FDA: Page 62
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De Novo-winning devices often lack effectiveness data, analysis shows
A JAMA Internal Medicine analysis of 63 devices reviewed via FDA's premarket pathway for novel technologies found one-fifth weren't evaluated in pivotal studies.
By Nick Paul Taylor • Oct. 13, 2020 -
Jacob Bell/MedTech Dive
FDA takes hands off EUA review for COVID-19 lab developed tests
The move follows the administration in August no longer requiring premarket review for LDTs, letting labs voluntarily seek emergency use nods. A lab trade group said the latest decision creates "unnecessary confusion."
By Greg Slabodkin • Oct. 8, 2020 -
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 -
'Tragedy' if FDA doesn't extend COVID-19 lessons beyond pandemic, Shuren says
Device head Jeff Shuren acknowledged the regulatory paradigm for medical devices is more than 40 years old and "not well suited for many modern-day technologies," speaking at AdvaMed's Virtual MedTech Conference.
By Greg Slabodkin • Oct. 7, 2020 -
Medical Alley, GI docs push to ease CMS device pass-through payments
The trade group for Medtronic, Boston Scientific and other medtech giants wants to bar Medicare contractors from making regional coverage decisions that obstruct transitional pass-through payments.
By Susan Kelly , Maria Rachal • Oct. 6, 2020 -
CMS officials elaborate on proposed breakthrough device coverage pathway
Agency representatives fleshed out details of proposed reimbursement meant to speed coverage of these technologies in a townhall webcast during AdvaMed's Virtual MedTech Conference.
By Susan Kelly • Oct. 6, 2020 -
AdvaMed sends CMS reform wishlist to boost digital health device coverage
The medtech industry group argues changes are needed for Medicare to realize the potential of a sector projected to be worth $500 billion by 2026.
By Nick Paul Taylor • Oct. 2, 2020 -
Adeline Kon/MedTech Dive
Deep Dive5 ways COVID-19 is reshaping the medtech industry
Remote tech, clinical trials and marketing are a few of the areas disrupted by the pandemic this year — with changes that look set to stick around.
By Maria Rachal , Greg Slabodkin • Oct. 1, 2020 -
Medtronic hit with DOJ ventilator antitrust probe
The investigation comes amid allegations that industry consolidation contributed to a shortage of the breathing devices during the early months of the COVID-19 pandemic.
By Greg Slabodkin • Oct. 1, 2020 -
FDA flags risk of infection with CardioQuip heater-cooler device
The alert comes after three patients were infected with mycobacteria. All such devices on the U.S. market have now been implicated in contamination, including those made by LivaNova, Cincinnati Sub-Zero, Maquet and Terumo.
By Nick Paul Taylor • Updated Oct. 1, 2020 -
Jacob Bell/MedTech Dive
FDA finalizes black box warning for breast implants
The term "breast implant illness," which one industry group decried as not used in clinical practice, appears multiple times throughout the agency's document but not in its example boxed warning.
By Susan Kelly • Updated Sept. 29, 2020 -
CMS lowers barriers for labs seeking COVID-19 test certification
Administrator Seema Verma said the new tools are designed to improve the "obscure process and outdated modes of payment" for labs to obtain CLIA certification to test for COVID-19 during the pandemic.
By Susan Kelly • Sept. 28, 2020 -
Hologic receives FDA emergency use for asymptomatic COVID-19 test
The nod for the test, which must be sent to a lab for results, comes as point-of-care tests that provide on-site results take off and are embraced by health officials and experts.
By Greg Slabodkin • Sept. 28, 2020 -
Courtesy of Abbott
Abbott gets CE mark for latest CGM with Dexcom still in the wings
The step is the latest in the rivalry between the two big players in the continuous glucose monitoring market, which Wall Street analysts contend leaves room for both to gain.
By Maria Rachal • Sept. 28, 2020 -
FDA finalizes overhauled guidance on device conformity testing pilot
The revised outline of the program, which will allow accredited labs to carry out premarket testing of medical devices, includes an expanded explanation of what the pilot means for device manufacturers.
By Nick Paul Taylor • Sept. 25, 2020 -
Jacob Bell/MedTech Dive
FDA grants EUA to first point-of-care COVID-19 antibody test
The lateral flow assay from Assure Tech achieved positive and negative percent agreements of 100% for IgG and IgM antibodies combined.
By Nick Paul Taylor • Sept. 24, 2020 -
FDA launches years-in-the-making digital health center
The center's focus areas will include the Pre-Cert program, AI and machine learning in software as a medical device, as well as cybersecurity and wireless medical devices.
By Susan Kelly • Sept. 23, 2020 -
Medtronic gets FDA breakthrough tag for device to prevent infections
The medtech giant has identified Tyrx as among the product lines to benefit from COVID-19.
By Nick Paul Taylor • Sept. 22, 2020 -
FDA De Novo OKs outpace 2019 with Spineology device, two others
A flurry of first-of-their-kind marketing authorizations comes as the agency may be receiving fewer new submissions compared to previous years, according to a MDUFA quarterly report.
By Susan Kelly • Sept. 22, 2020 -
ACLA pushes back ahead of MedPAC's 2021 report to Congress on lab fee rates
The trade group for LabCorp and Quest is wary that the Commission's rate recommendations due in June could end up being overly burdensome and not reflective of the market for all lab services.
By Greg Slabodkin • Sept. 22, 2020 -
CMS to push back radiation oncology model after industry blowback
Agency administrator Seema Verma said a six-month delay will be formalized via upcoming rulemaking because "more time is needed to prepare."
By Susan Kelly • Updated Oct. 22, 2020 -
Trump admin unveils final kidney care payment model
The CMS policy seeks to incentivize more at-home dialysis treatment, which could have implications for device makers including Baxter and newly public Outset Medical.
By Samantha Liss • Sept. 18, 2020 -
Jacob Bell/MedTech Dive
PerkinElmer tops FDA COVID-19 test sensitivity list, with BD and Roche scoring lower
PerkinElmer’s coronavirus nucleic acid kit achieved the lowest limit of detection, indicating greater sensitivity or ability to accurately detect the virus, in an agency comparison of 58 tests.
By Nick Paul Taylor • Sept. 18, 2020 -
Alex Wong via Getty Images
Nixed Philips, Hamilton, Vyaire ventilator contracts subject of expanding House probe
The oversight subcommittee wants to know if the HHS cancellation of "wasteful" contracts with the three medtechs included generous termination settlements involving payoffs to the companies.
By Greg Slabodkin • Sept. 17, 2020 -
Roche gets FDA nod for faster combo coronavirus-flu test
The diagnostic, designed to detect and differentiate SARS-CoV-2 and influenzas A and B, gives results within 20 minutes, compared to a prior authorized version for a Roche system with an hours-long turnaround.
By Greg Slabodkin • Sept. 16, 2020 -
FDA finalizes voluntary consensus standard guidance
The final guidance offers updated advice for submitting requests for recognition in the premarket review process and explains when the agency may withdraw a previously recognized standard.
By Susan Kelly • Sept. 15, 2020
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