• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • Biopharma M&A scorecard
  • BioWorld 2024 review
  • BioWorld MedTech 2024 review
  • BioWorld Science 2024 review
  • Women's health
  • China's GLP-1 landscape
  • PFA re-energizes afib market
  • China CAR T
  • Alzheimer's disease
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Authors » Mark McCarty

Articles by Mark McCarty

Illustration of male vs. female bodies showing organs

FDA eyes update to 2014 guidance on sex-specific study considerations

Jan. 14, 2025
By Mark McCarty
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.
Read More
3D map of China

European Commission pushes back on Beijing’s med-tech policy

Jan. 14, 2025
By Mark McCarty
Beijing’s policy of favoring domestic medical technology is a matter of record, but the European Commission apparently heard enough from EU med tech firms to take action. The Commission posted notice that it may take steps to retaliate by restricting bids from China for EU government contracts in retaliation, a move certain to draw cheers from European device makers.
Read More
Recor Medicaal Paradise renal denervation catheter

CMS opens national coverage analysis for renal denervation

Jan. 14, 2025
By Mark McCarty
U.S. Medicare coverage of renal denervation (RDN) for uncontrolled hypertension may soon be a fact of life if the manufacturers of these systems have their way. CMS opened a national coverage analysis for RDN, but as is routine practice recently, the agency is asking for comment before posting even a draft coverage memo for this technology.
Read More
Laptop displaying FDA logo

Industry blasts FDA for requiring full ASCA conformity test reports

Jan. 13, 2025
By Mark McCarty
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program has its benefits, but industry had some sharp words for the agency in commenting on the 2024 ASCA draft guidance. The Advanced Medical Technology Association stated that FDA reviewers asked for full conformity test results for roughly 5% of premarket applications, a rate seen as excessive given the program’s design.
Read More
Illustration of male vs. female bodies showing organs

FDA eyes update to 2014 guidance on sex-specific study considerations

Jan. 13, 2025
By Mark McCarty
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.
Read More
CMS logo and website

Congressional disinterest in CMS appropriations likely to persist

Jan. 7, 2025
By Mark McCarty
The discussion about taxpayer appropriations for CMS has been ongoing for decades, leading to futile speculation regarding user fees for the agency. Louis Jacques, who formerly worked at CMS, told BioWorld that Congress tends to be somewhat reactive when it comes to appropriations for CMS – a dynamic which suggests that appropriations for CMS are not likely to improve significantly in the near term.
Read More
Masimo MightySat pulse ox

FDA forcing industry’s hand on pulse-ox sensitivity to pigmentation

Jan. 7, 2025
By Mark McCarty
The question of how skin pigmentation affects the performance of pulse oximeters has drawn the U.S. FDA’s close attention for several years, and the agency issued a draft guidance to address these questions. The draft guidance recommends that new and existing devices be evaluated to establish performance across different pigmentations, a development that would address concerns among clinicians and patients alike.
Read More
Cyber security padlock

HHS floats much more stringent set of HIPAA security measures

Jan. 6, 2025
By Mark McCarty
Makers of digital health apps are not often subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), but any such liabilities may soon become more onerous. The Department of Health and Human Services released a draft update for HIPAA cybersecurity mandates – the final version of which is sure to be accompanied by much more vigorous enforcement.
Read More
AI biotech research concept with lightbulb and digital background

FDA inks draft guidance for AI applicable across product centers

Jan. 6, 2025
By Mark McCarty
Some people may have seen 2024 as the year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance. While the draft covers both premarket submissions and life cycle management considerations, the more important consideration is that the FDA’s centers for devices, drugs and biologics have all signed off on the draft, suggesting an agency-wide convergence in thinking about AI.
Read More
Hourglass on glowing circuit board, symbolizing time and technology
Year in review

EU’s med-tech regulatory struggles continue into 2025

Jan. 3, 2025
By Mark McCarty
Regulatory overhauls are never a simple affair, but the med tech industry ran into an amorphous, ennui-inducing mess in dealing with the EU Medical Device Regulation almost immediately. Even though the underlying legislation passed in 2017, the MDR impasse continued to impede innovation on the continent – a problem that might be only partly resolved in 2025.
Read More
Previous 1 2 … 9 10 11 12 13 14 15 16 17 … 554 555 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 22, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for May 22, 2025.
  • Brain with handshake and cityscape

    Vigil takeover brings TREM2 Alzheimer’s prospect to Sanofi

    BioWorld
    Sanofi SA made good on its plan to bear down on M&A by agreeing to buy Vigil Neuroscience Inc. for $8 per share (NASDAQ:VIGL). Included in the transaction is a...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for May 20, 2025
  • Drug capsule and dollar sign

    Little bite from voluntary most-favored nation Rx pricing order

    BioWorld
    After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite,...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe