• 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 » FDA: Aethlon can sell unapproved blood filter in India | Regulatory roundup

FDA: Aethlon can sell unapproved blood filter in India | Regulatory roundup

March 8, 2011 By MassDevice staff

Clearances roundup

Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.

  • FDA: Aethlon can sell unapproved blood filter in India
    Aethlon Medical Inc. (OTC:AEMD) announced that the Food & Drug Administration granted the company’s request to export its Hemopurifier medical device to India. The FDA’s approval was given under Section 801 (e) of the Federal Food, Drug and Cosmetic Act, which covers class III medical devices, such as the Hemopurifier, that have not yet received an approval in the U.S. by the FDA. Section 801 (e) applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing Practices. San Diego-based Aethlon is currently conducting a clinical study for the Hemopurifier for treating chronic HCV infection at the Medicity Institute near Delhi, India.
    Read more
  • Wright Medical launch hammertoe fixation device
    Arlington, Tenn.-based Wright Medical Group Inc. (NSDQ:WMGI) launched its PRO-TOE VO hammertoe fixation system. The device won 510(k) clearance from FDA last July. This system was designed in cooperation with world-renowned foot and ankle surgeons to offer a simple and efficient means to surgically repair the lesser toes following correction of a hammertoe deformity. A hammertoe is a contracture of the tissues surrounding the joints of the lesser toes, causing significant pain and discomfort in addition to an altered physical appearance. It is estimated that 10 to 20 percent of the U.S. population will suffer from hammertoes at some point in their life.
    Read more
  • Guided predicts delay in FDA approval for cervical cancer test
    The FDA has inspected two clinical trial sites as part of its review process for Norcross, Ga.-based Guided Therapeutics Inc. (OTC:GTHP)’s LightTouch non-invasive test for the early detection of cervical pre-cancer and raised no formal compliance issues. Advanced Scientifics Inc., the manufacturer of the company’s single-patient-use disposable patient interface, also reported a successful FDA inspection. "Given the timing of the FDA’s inspections and questions, though, it now appears less likely we will be part of the next Obstetrics and Gynecology Devices Panel meeting, tentatively scheduled for May 19-20," CEO Mark Faupel said in prepared remarks. "Still, we believe it is possible to meet our target for a year end 2011 or early 2012 launch in the U.S. with the next currently scheduled panel meeting date in September, 2011," he said. The PMA was accepted for filing as on Sept. 23, 2010.
    Read more
  • Spacelabs Healthcare wins FDA clearance for anesthesia system
    OSI Systems Inc. (NSDQ:OSIS) division Spacelabs Healthcare of Issaquah, Wash. received FDA 510(k) clearance for "Enhanced Flow Meter" visualization on its BleaseSirius anesthesia system. With the EFM, patient data becomes immediately available for export to patient monitoring and hospital information systems.
    Read more
  • Henry Schein wins ONC certification for EHR system
    Melville, N.Y.-based Henry Schein Inc. (NSDQ:HSIC) announced that its MicroMD EMR Version 7.5 achieved ONC-ATCB 2011/2012 Complete EHR (Electronic Health Record) Certification, and can help health care providers using electronic health record technology meet the requirements needed to receive financial incentives earmarked under President Obama’s American Recovery and Reinvestment Act (ARRA) of 2009. MicroMD EMR Version 7.5 attained ONC-ATCB 2011/2012 Complete EHR certification status through the Certification Commission for Health Information Technology (CCHIT), a U.S. Office of the National Coordinator – Authorized Testing and Certification Body (ONC-ATCB).
    Read more

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Aethlon Medical Inc., Gift Bans, Guided Therapeutics Inc., Henry Schein Inc., OSI Systems Inc., wrightmedical

More recent news

  • 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
  • Ambu wins FDA clearance for first single-use cysto-nephroscope

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