• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Boston Scientific’s Alair asthma treatment gets a thumbs-up | Regulatory Roundup

Boston Scientific’s Alair asthma treatment gets a thumbs-up | Regulatory Roundup

March 29, 2012 By MassDevice staff

MassDevice.com Regulatory Roundup

 BSX’s Alair asthma system gets the OK from CTAF
Boston Scientific‘s (NYSE:BSX) Alair bronchial thermoplasty system met all 5 safety and effectiveness endpoints in a review by the California Technology Assessment Forum.

CTAF members concluded that the device has FDA approval, has scientific support of its claims to improve health outcomes for chronic asthma patients, does in fact improve health outcomes, is as beneficial as any alternative treatment option and provides an improvement that’s unattainable outside of investigational settings.

The Alair system delivers precise thermal energy to lung tissue via bronchoscope to reduce excessively smooth muscle, decreasing the airways’ ability to constrict.

The Natick, Mass.-based met-tech titan recently won a nod from the Centers for Medicare & Medicaid Services, which approved reimbursement for the Alair device via a separate "pass-through" payment when the procedure is performed in outpatient settings.

The report represents the 1st published technology assessment in support of the Alair system, according to Boston Scientific. Read more

 FDA warns Lucero Medical on Enduramesh manufacturing
The FDA warned Lucero Medical on manufacturing violations of its Enduramesh implantable spinal vertebral replacement devices, which the federal watchdog agency said were not subject to proper design control procedures, complaint handling practices and other necessary measures.  Read more

 FDA warns IntelliCell Biosciences on marketing of aesthetic stem cell treatment
The FDA warned IntelliCell Biosciences that it needs to obtain proper licenses for its IntelliCell stem cell treatment, which it markets as an aesthetic therapy which "can be used "off-label to treat various patient ailments." Read more

 FDA releases final guidance on benefit-risk determinations
The FDA’s Center for Devices & Radiological Health released a finalized guidance on the how the federal watchdog agency will balance benefits and risks when reviewing pre-market approval and de novo applications for medical devices. Read more

More medical device regulatory news from MassDevice.com

 Zoll wins 510(k) for X series monitor defibrillator

 SoundCure touts FDA clearance and CE Mark for Seranade tinnitus treatment system

 Given Imaging lands expanded Japanese indication for PillCam

 Athersys wins German OK for solid organ transplant trial

 Smiths Medical withdraws CoZmonitor blood glucose system as test strips are discontinued

 Merit Medical lands 510(k) for QuadraSphere Microspheres

 VentriPoint wins CE Mark for pulmonary arterial hypertension application

 Cardica applies CE Mark to its MicroCutter Xchange surgical cutting and stapling system

 Benvenue Medical enrolls 250th patient in Kast trial for Kiva vertebral augmentation system

 SpinalMotion touts CE Mark for 2 Kineflex cervical disc implants

 Imalux lands CE Mark for Niris OCT system

Filed Under: News Well Tagged With: Ablation, Asthma, Athersys Inc., Benvenue Medical Inc, Boston Scientific, California Technology Assessment Forum, dextera, Given Imaging, Imalux Corp., IntelliCell Biosciences, Lucero Medical, Merit Medical Systems, Smiths Medical, SoundCure, SpinalMotion Inc., VentriPoint, Zoll Medical

More recent news

  • Tandem continues to deliver more options, benefits for those with diabetes
  • Breaking: Sequel to launch twiist automated insulin delivery system next month
  • Dexcom shares U.S. report on CGM benefits for type 2 diabetes
  • Data backs Medtronic MiniMed 780G for type 2, children as company seeks expanded indications
  • Endogenex data supports type 2 diabetes procedure

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy