• 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 » Newsletters » BioWorld MedTech

BioWorld MedTech

May 11, 2022

View Archived Issues
regulatory-green-light-approved.png

Neuronetics wins FDA nod for Neurostar TMS for OCD

The FDA has greenlighted Neuronetics Inc.’s Neurostar transcranial magnetic stimulation (TMS) system as an adjunct treatment for adults with obsessive-compulsive disorder (OCD). The noninvasive treatment, which uses repetitive, focused magnetic pulses to stimulate brain cells, is already cleared and marketed in the U.S., Japan and select other countries for major depressive disorder (MDD). Read More

Updated guidelines add Oncotype Dx GPS and Isopsa for prostate cancer decision-making

As the American Urological Association (AUA) annual meeting prepares to kick off on May 12, newly published prostate cancer guidelines recommend two tests to help clinicians and patients determine the best path forward for treatment—or waiting. The latest AUA guidelines incorporated Exact Sciences Corp.’s Oncotype DX Genomic Prostate Score (GPS) test for risk-stratification of localized prostate cancer, while the National Comprehensive Cancer Network (NCCN) added Cleveland Diagnostics Inc.’s Isopsa test to help identify high-grade early prostate cancer before a biopsy or after a negative biopsy result. Read More
washington-dc-1624419.png

FDA user fee legislation passes first hurdle in House of Representatives

The legislation that would renew a number of FDA user fee programs, the Food and Drug Amendments Act (FDA Act) of 2022, has passed the first legislative hurdle in a subcommittee of the U.S. House of Representatives, but there are several issues with the bill. According to members of the subcommittee, the issues include an absence of provisions for medical device servicing, and the absence of legislation for FDA regulation of lab-developed tests (LDTs), issues that are unlikely to be resolved before the legislation is passed out of the House. Read More
U.S. Capitol and $100 bills

US lawmakers question budget fulcrum for ARPA-H, NIH

With its focus on transformative high-risk, high-reward research to drive biomedical breakthroughs, the new Advanced Research Projects Agency for Health (ARPA-H) may be a good concept, but it shouldn’t come at the expense of increased investment in basic research at the NIH, according to the bipartisan leadership of U.S. House appropriators. Read More
Microchip robotic manufacturing concept

From promise to execution, digital health innovators reach for new heights

In the post COVID world, digital transformation is at the forefront of every company’s agenda, but which innovations can fuel the next era of health care? At the ongoing Biomed Israel conference in Tel Aviv, Anat Naschitz founder and CEO of 9xchange and co-founder of Orbimed Israel, lead a digital health track exploring the technologies aiming to reconstruct the future of health care. Read More
Magneto’s Etrieve

Magneto shares FIH results for blood clot removing catheter

At the ongoing Biomed Israel 2022 event, Magneto Thrombectomy Solutions Ltd. has shared successful first-in-human (FIH) results showing safety and feasibility of its Etrieve system, a novel catheter based on electric fields for removing blood clots, in patients with acute pulmonary embolism (PE). Read More

Appointments and advancements for May 11, 2022

New hires and promotions in the med-tech industry, including: Acera Surgical, Beta Bionics, Fairtility, Physiq, Prophase Labs, Uromems, Virta Health. Read More

Financings for May 11, 2022

Med-tech firms raising money in public or private financings, including: Sequentify. Read More

In the clinic for May 11, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Coaptech, Magneto. Read More

Other news to note for May 11, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Babson Diagnostics, BD, Blirt, Bristol Meyers, Check-Cap, Cosylab, Elekta, Evotec, Kaiku Health, Microtransponder, Neutron Therapeutics, Northern Pacific, Qiagen, Roche, Unidoc. Read More

Regulatory actions for May 11, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inex Innovate, Neuronetics. Read More

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 16, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for May 19, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for May 13, 2025
  • Gilead Sciences discovers new PRMT5 inhibitors

    BioWorld Science
    Gilead Sciences Inc. has described protein arginine N-methyltransferase 5 (PRMT5) inhibitors reported to be useful for the treatment of cancer.
  • Elderly person receiving shot

    With FDA vaccine nod, Novavax takes ACIP of new COVID-19 rules

    BioWorld
    Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s...
  • 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