FDA: Page 54


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    Jacob Bell
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    FDA starts review of how skin pigmentation affects pulse oximeter results

    The agency is evaluating published literature related to factors that may affect device accuracy and performance, following pressure from senators to address concerns that "racism may be embedded in key clinical tools."

    By Feb. 22, 2021
  • Boston Scientific's ICD recall gets 2nd Class I label from FDA

    A new agency notice covers a fault that allows moisture to enter the medical device, causing it to short circuit when it tries to shock the patient. Boston Scientific has not received reports of injuries or deaths linked to the problem.

    By Feb. 22, 2021
  • the FDA Headquarters Explore the Trendline
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    Why this week's FDA meeting on J&J's coronavirus vaccine will be important

    The agency is widely expected to OK the one-dose shot, but the advisory panel will offer a window into debate over several key issues, including related to the new virus variants. 

    By Ben Fidler , Ned Pagliarulo • Feb. 22, 2021
  • Chiquita Brooks LaSure, reportedly picked to be CMS administrator for President Joe Biden
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    Retrieved from Manatt on February 18, 2021
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    Obama admin alum Chiquita Brooks-LaSure tapped to head CMS

    AdvaMed backed the nomination, noting a new Medicare rule that gives developers of FDA-designated breakthrough devices the potential to sell them and be reimbursed on the day of market approval.

    By Shannon Muchmore • Feb. 18, 2021
  • BD drug-coated balloon falls short at FDA panel, signaling likely rejection

    While the advisory committee largely agreed that Lutonix was safe, the majority did not believe it was effective nor that the benefits outweighed the risks.

    By Feb. 18, 2021
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    Jacob Bell
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    FDA approves 3D-printed ankle implant for humanitarian use

    Additive Orthopaedics makes the devices from cobalt chromium alloy to treat avascular necrosis, a rare bone disease. It is the first patient-specific total talus replacement implant approved by the agency.

    By Feb. 18, 2021
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    Brian Tucker
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    COVID-19 EUAs drive FDA to record 2020 novel device OKs

    The tally tops the 106 novel device authorizations in 2018 that marked a 40-year high. 

    By Feb. 17, 2021
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    Fotolia
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    One-third of US adults postponed care during pandemic: reports

    Among those surveyed, 25% put off dental care, while 21% put off checkups and 16% put off screenings or medical tests, researchers from the Urban Institute and RWJF found.

    By Ron Shinkman • Feb. 16, 2021
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    Jacob Bell/MedTech Dive
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    BD drug-coated balloon faces uphill battle in FDA panel review

    Advisers on Wednesday are weighing the PAD treatment, but the agency has said data limitations make it hard to draw conclusions about safety and effectiveness. Evercore ISI analysts predict a negative vote.

    By Updated Feb. 17, 2021
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    FDA admits COVID-19 antibody test policy was 'flawed,' offers lessons for future outbreaks

    Writing in the New England Journal of Medicine, agency officials acknowledged "touting the potential usefulness" of serology tests early in the pandemic contributed to flooding the market with poorly performing diagnostics.

    By Feb. 16, 2021
  • In run-up to MDR, EU posts guide to legacy devices in Eudamed

    The guidance explains when manufacturers need to register on the new database and walks through details such as how to link products covered by the outgoing and new regulatory frameworks.

    By Feb. 15, 2021
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    Jacob Bell
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    Visby gets FDA nod for single-use, rapid point-of-care COVID-19 PCR test

    The palm-sized diagnostic gives results in 30 minutes without the need for additional instruments or readers. While Abbott's ID Now provides results in 13 minutes or less, it is the size of a toaster and requires a cartridge. 

    By Feb. 10, 2021
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell/MedTech Dive
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    Heart disease devices lead latest batch of FDA breakthrough nods

    The cardiovascular-focused products are part of a wider group of designations including those in development at companies such as Roche. 

    By Feb. 10, 2021
  • Medicare DME competitive bidding in doubt after failed round: analysts

    Cowen analysts said a recent report found steep rate hikes, leading them to conclude the program is no longer such a big threat to companies like Baxter, ResMed and Philips.

    By Feb. 8, 2021
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    Jacob Bell
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    FDA OKs Signifier neurostim device for snoring, sleep apnea

    Signifier now faces the challenge of establishing eXciteOSA in the congested snoring and sleep apnea market targeted by companies including ResMed.

    By Feb. 8, 2021
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell/MedTech Dive
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    FDA appoints first medical device cybersecurity chief

    University of Michigan professor Kevin Fu will serve a one-year term as acting cyber director at the Center for Devices and Radiological Health. Experts fear the chaos of the pandemic creates the perfect storm for hackers to exploit.

    By Feb. 3, 2021
  • Death, injuries prompt FDA to call Boston Scientific ICD recall Class I event

    The device giant began recalling the subcutaneous implantable defibrillator system electrode late last year after learning of 26 serious injuries and one death associated with the device.

    By Feb. 3, 2021
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    Courtesy of Ellume Health
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    DoD awards Ellume $231M to increase US production of at-home, OTC COVID-19 test

    The Australian diagnostics company will use the funding to establish a U.S. manufacturing facility that is projected to increase production capacity by 640,000 tests per day by December.

    By Feb. 2, 2021
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    Brian Tucker Industry Dive Image | courtesy of California Office of Attorney General
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    How might Xavier Becerra operate as HHS Secretary?

    The nominee has made headlines since leaving the House of Representatives, in part by leading blue state efforts to defend the ACA. Less high-profile, perhaps, were his efforts to block major hospital mergers in California.

    By Ron Shinkman • Feb. 1, 2021
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    Deep Dive

    3 big predictions for digital health in 2021

    As tech and data sharing become more pervasive, healthcare will likely pivot to being more predictive and telehealth will evolve, giving rise to new modalities of care. This will force companies to invest more in cybersecurity.

    By Rebecca Pifer • Jan. 29, 2021
  • Low Medicare EKG device draft slams iRhythm, stock price sinks by over 30%

    Wall Street analysts questioned whether the lower-than-expected rates are final and what the prospects are for renegotiation. Shares of market leader iRhythm fell over 32% on Friday.

    By Updated Feb. 1, 2021
  • Colorized scanning electron micrograph of a cell heavily infected with SARS-CoV-2 virus particles, isolated from a patient sample
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    Vaccine makers prepare response as coronavirus mutations raise alarms

    So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't.

    By Jonathan Gardner • Jan. 28, 2021
  • A vial of BioNTech and Pfizer's coronavirus vaccine
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    Courtesy of BioNTech
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    Biden invokes DPA to combat supply shortages, but experts say it's no 'magic wand'

    AdvaMed early in the pandemic urged against using the Defense Production Act's powers, though some companies were more open. The device lobby last week asked the administration to coordinate with industry before taking action.

    By Matt Leonard • Jan. 27, 2021
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    Brian Tucker/MedTech Dive
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    4 key trends for payers and providers in 2021

    The COVID-19 crisis may spur speedier adoption of value-based care and partnerships between health systems and payers in the year ahead.

    By Samantha Liss • Jan. 22, 2021
  • Q&A

    ACLA seeks lab reimbursement changes as need for COVID-19 testing surges

    Julie Khani, president of the American Clinical Laboratory Association, which includes Quest and LabCorp, says there are coverage gaps and that clarifications are needed for which tests are paid for by insurers.

    By Jan. 22, 2021