AIUM supports FDA decision to deny over-the-counter use of handheld doppler fetoscopes

The American Institute of Ultrasound in Medicine (AIUM) supports the decision of the US Food and Drug Administration (FDA) to deny a request that would permit over-the-counter (OTC) sales of certain handheld Doppler ultrasound fetal listening devices, also referred to as Doppler "fetoscopes."

The FDA conducted a public meeting on March 29, 2006, to discuss the issue in response to a petition for OTC use filed in June 2004. Representatives from the AIUM attended the session and provided both their input and opposition to the petition. AIUM President Lennard Greenbaum, MD, stated that the "AIUM strongly discourages the nonmedical use of ultrasound, and although there are no confirmed biological effects on patients caused by exposure from present diagnostic ultrasound incidents, the possibility exists that such biological effects may be identified in the future." AIUM Bioeffects Committee Chair Jacques Abramowicz, MD, and AIUM President-Elect Joshua Copel, MD, presented the AIUM's scientific findings, concluding that caution should be exercised in using these devices, emphasizing adherence to the ALARA or "as low as reasonably achievable" principle. In addition, they thought there was no clear benefit to the consumer from OTC availability of handheld fetal Doppler devices.

Doppler fetoscopes are currently available by prescription for home use, usually in cases involving high-risk pregnancies. In its letter declining the petition, the FDA stated its belief that "the available scientific literature and the consensus of the scientific community substantiate the current regulatory status of these devices, which provides access for home use when the mother and her physician decide such monitoring is indicated."


Contact: Jennifer Hilderbrand
American Institute of Ultrasound in Medicine

Page: 1

Related biology news :

1. NIAID supports research into etiology of fungal-induced inflammation in chronic sinusitis
2. ESA open-source software supports Germanys TerraSAR-X
3. National Science Foundation supports UCR study of polar lake life forms
4. Hofmeyr skull supports the Out of Africa theory
5. USC study in Nature Genetics supports a stem cell origin of cancer
6. Conference supports minority students to pursue biomedical careers
7. Study supports urgent need for worldwide ban on lead-based paint
8. Slow-frozen people? Latest research supports possibility of cryopreservation
9. Award supports Virginia Tech research to reduce vehicle emissions, create biofuel
10. Taxpayer Alliance supports senate bill broadening access to federal research
11. DARPA grant supports research toward realizing tissue regeneration

Post Your Comments:

(Date:5/28/2020)... ... 27, 2020 , ... CrucialTrak, a global designer and manufacturer of biometric access ... (CEG) to market and sell its complete line of biometric readers and access ... infrastructure optimization solutions . , Brett Mason, CrucialTrak’s Director of Channel Sales for ...
(Date:5/28/2020)... ... May 28, 2020 , ... Actuate Therapeutics, ... their 1801 Phase 1/2 study (NCT03678883, EudraCT #: 2018-003739-32) will be presented at ... place virtually on May 29th, 2020. Dr. Benedito Carneiro, Brown University’s principal investigator ...
(Date:5/21/2020)... ... May 21, 2020 , ... ... background and medical screening, announces the launch of a testing service aimed ... safe. The new service is provided by ClearStar’s Medical Information Services (“MIS”) ...
Breaking Biology News(10 mins):
(Date:6/23/2020)... ... 23, 2020 , ... Kerafast Inc. , developers of ... the availability of the Delta-G-VSV Pseudotyping System for coronavirus research applications. The system, ... SARS-CoV-2 viral entry and COVID-19 vaccine effectiveness at just biosafety level 2 (BSL-2) ...
(Date:6/23/2020)... ... June 22, 2020 , ... Dracen Pharmaceuticals Inc., announced today ... 22-24 during the American Association for Cancer Research Virtual meeting. One poster describes ... consistent single agent activity in KEAP1 mutant tumor models of NSCLC. ...
(Date:6/11/2020)... ... , ... Greffex, a leading genetic engineering company, with the ... vectors, recently announced a key manufacturing agreement with FUJIFILM Diosynth Biotechnologies to produce ... successful gene therapy delivery vehicle (vector) with broad applications for delivering treatments including ...
(Date:6/11/2020)... ... 2020 , ... Reducing carbon emissions has been and will continue to be ... market dips, ways to reduce CO2 is something we can’t avoid. , To ... biofuels being produced today are created from recycled cooking oil or crops. Unfortunately, these ...
Breaking Biology Technology:
Cached News: