FDA: Page 42
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Neurostimulator to treat stroke fails to gain FDA advisory panel support
The panel questioned whether modifications in the pivotal trial for the device from BrainsGate, a company that attracted early investment from Boston Scientific and J&J, could have compromised the study.
By Susan Kelly • Dec. 13, 2021 -
Sarah Silbiger via Getty Images
FDA seeks comment on 3D printing of medical devices at hospitals, doctor's offices
The agency's discussion paper lays out the benefits and challenges of creating 3D-printed devices in healthcare settings as well as a potential approach for regulatory oversight.
By Greg Slabodkin • Dec. 13, 2021 -
Explore the Trendline➔
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
FDA floats independent contractor to track MDUFA hiring following medtech pressure
The agency made the offer during the Medical Device User Fee Amendments V meetings in response to industry negotiators who want a clearer picture of how the program uses the money it receives.
By Nick Paul Taylor • Dec. 9, 2021 -
Megan Quinn/MedTech Dive
Senate passes legislation to avoid Medicare cuts for providers in year-end sprint
Groups like the American Hospital Association came out in support of the legislation, which would mitigate some of the cuts set to soon take effect.
By Rebecca Pifer • Updated Dec. 10, 2021 -
Stefan Zaklin / Stringer / via Getty Images via Getty Images
Senate passes bill to delay 2022 Medicare rate cuts for hundreds of lab tests
Senators late Thursday passed an end-of-year package that will delay the 15% cuts for nearly 600 tests slated to kick in next month. Passed by the House on Tuesday, the bill must still be signed by President Joe Biden to become law.
By Greg Slabodkin • Updated Dec. 10, 2021 -
Sarah Silbiger via Getty Images
Cancer treatments lead latest FDA breakthrough device designations
The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.
By Nick Paul Taylor • Dec. 7, 2021 -
Sarah Silbiger via Getty Images
Thermo Fisher, Verily on FDA list of COVID-19 tests affected by omicron variant
The agency's list focuses on coronavirus diagnostics impacted by S-gene dropout, an occurrence that is most commonly associated with Thermo Fisher Scientific's TaqPath test kits.
By Nick Paul Taylor • Dec. 6, 2021 -
Stefan Zaklin / Stringer / via Getty Images via Getty Images
Congress passes on delay to Medicare rate cuts for lab tests, for now
The American Clinical Laboratory Association wants lawmakers to push off 2022 cuts for nearly 600 lab tests. A stopgap bill late last week did not include a reprieve, but Cowen analysts are optimistic a legislative fix will be found.
By Greg Slabodkin • Dec. 6, 2021 -
Insulet Omnipod 5 release
Insulet's Omnipod 5 insulin pump cleared by FDA after months of delays, sending shares up 9%
The clearance better positions Insulet to compete with rival Tandem Diabetes Care, and comes while Medtronic's diabetes group is managing multiple product safety problems.
By Susan Kelly , Ricky Zipp • Updated Jan. 28, 2022 -
Sarah Silbiger via Getty Images
Device recalls jumped 36% in Q3, first quarterly increase since 2020: report
The primary reasons for recalls in the quarter were software issues, which have been the leading causes in 21 of the last 22 quarters, according to Sedgwick's November U.S. product recall index.
By Ricky Zipp • Dec. 3, 2021 -
WhiteHouse.gov
Biden orders private health insurers to cover COVID-19 home tests
Test makers such as Abbott, BD and Quidel could see demand increase as costs for consumers are reimbursable. The White House is also doubling distribution of free at-home tests to uninsured and underserved communities.
By Nick Paul Taylor • Dec. 3, 2021 -
Sarah Silbiger via Getty Images
NuVasive resumes US shipments of titanium-based orthopaedic devices, gets FDA thumbs up
The agency voiced its support for the reintroduction of the Precice products, telling healthcare providers that the availability of the devices is in the best interests of patients as the benefits outweigh the known risks.
By Nick Paul Taylor • Dec. 2, 2021 -
EU finalizes implementing regulation for Eudamed medical device database
The European Commission has provided a framework for the basic operation of the system, slated for a May 2022 launch, including how to access it, what it will do in the event of a database malfunction and IT security measures.
By Nick Paul Taylor • Dec. 2, 2021 -
Win McNamee via Getty Images
Deep DiveMedical device security continues to be casualty of hospital-medtech divide
FDA says manufacturers and hospitals are both responsible for protecting devices from growing cybersecurity threats. However, experts say healthcare providers carry a much heavier load.
By Greg Slabodkin • Dec. 1, 2021 -
Getty Images
Cyber playbook sets out strategies for modeling threats to medical devices
The FDA-funded guide arrives against a backdrop of calls from the agency for the medtech industry to step up its threat modeling throughout the device lifecycle in order to strengthen cybersecurity and patient safety.
By Nick Paul Taylor • Dec. 1, 2021 -
Getty Images
FDA updates eSTAR ahead of expanding filing template for De Novo submissions
The platform has been available for manufacturers to voluntarily submit 510(k) submissions since September 2020. The agency will start accepting De Novo applications when a final rule takes effect early next year.
By Nick Paul Taylor • Nov. 30, 2021 -
Getty Images
BD test, others among rapid antigen kits authorized for one-time use by FDA
The agency has authorized another three over-the-counter COVID-19 antigen home tests for single use in people with symptoms, furthering the emergence of the kits as an alternative to PCR.
By Nick Paul Taylor • Nov. 29, 2021 -
IVDR milestone as EU expert panel delivers first opinion on a diagnostic submission
The In Vitro Diagnostic Medical Devices Regulation panel, which got off to a rocky start earlier this year, provided a glowing assessment of a test by an undisclosed company that screens plasma donor samples for hepatitis E virus.
By Nick Paul Taylor • Nov. 29, 2021 -
Biden admin investing $1.5B to quell healthcare staffing shortages, promote workforce equity
The funding is meant to address staffing shortages that have been exacerbated by the pandemic and impacted the entire healthcare industry, from hospitals to medical device companies.
By Hailey Mensik • Nov. 24, 2021 -
Jacob Bell/MedTech Dive
FDA resumes domestic surveillance inspections as omicron cases decline
The regulator has restarted the examinations, following a six-week freeze in response to the variant's surge. FDA plans to conduct foreign prioritized inspections starting in April.
By Nick Paul Taylor • Updated Feb. 7, 2022 -
CMS proposes smokers begin lung cancer screening at age 50 instead of 55
The agency is revisiting its national coverage determination to catch the disease at an earlier stage. Needham analysts say a larger pool of patients will drive demand for test makers Veracyte, Oncocyte and NeoGenomics.
By Susan Kelly • Nov. 22, 2021 -
Sarah Silbiger via Getty Images
Latest breakthrough device designations go to brain-computer interface, exo-suit
Regulatory privileges were awarded to Blackrock Neurotech's brain-computer interface, designed to assist immobile patients with performing activities, and ReWalk Robotics' exo-suit, which is intended to help stroke patients walk.
By Nick Paul Taylor • Nov. 22, 2021 -
FDA shakes up hepatitis C testing market by opening up 510(k) pathway
Lowering the barrier to the market could increase competition in spaces targeted by companies such as Abbott Laboratories and Roche.
By Nick Paul Taylor • Nov. 22, 2021 -
Permission granted by iRhythm Technologies
Q&ANew iRhythm CEO talks Medicare pricing, larger medtech competitors, international markets
"I think the near-term noise is something that we'll work through, but the underlying technology has never been questioned," Quentin Blackford told MedTech Dive.
By Ricky Zipp • Nov. 19, 2021 -
Sarah Silbiger via Getty Images
FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults
The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country.
By Ben Fidler • Nov. 19, 2021
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