OdonAssist is CE marked and can only be sold in countries that recognize the CE mark. It is not available for sale in other countries and jurisdictions until local regulatory approvals and clearances have been obtained.

Frequently asked questions

What makes OdonAssistTM different?
OdonAssist™ is a new choice, the first truly breakthrough innovation in assisted birth in more than a century.21 Its soft, inflatable air cuff has been shown in clinical studies to be gentle,4-6 safe and easy to use,3-5 with no typical pattern of the neonatal bruising or injury that can result from the use of other assisted vaginal birth devices.4,5

Unlike forceps and vacuum extraction, with OdonAssist™ the insertion technique is the same for all fetal head positions in cephalic vertex presentations.3-5
Who can have an assisted birth with OdonAssistTM?
The OdonAssist™ is used to perform assisted vaginal birth in women with term pregnancies and cephalic vertex presentation (occiput anterior, occiput posterior and occiput transverse fetal head positions) with fetal stations at 1 cm or below ischial spines.The indications for the OdonAssist™ are as follows:    
  1. Prolonged second stage of labour
  2. Suspected fetal compromise in the second stage of labour
  3. Other medical indications to shorten second stage of labour
Is OdonAssist™ reusable?
No. OdonAssistTM is a sterile, single use, disposable obstetric medical device.
Is OdonAssist latex free?
The OdonAssist bulb pump is made of natural rubber latex. The latex component is largely covered by the device’s strap. In clinical use, healthcare professionals typically wear gloves during delivery, which further limits any contact with intact skin. There is also no foreseeable direct contact between the latex component and the mother or the baby.
How are clinicians trained to use OdonAssistTM?
In collaboration with leading obstetricians, MNHI has developed an extensive training program for obstetricians and maternity staff, consisting of detailed instructions for use, user manuals, videos, posters, and even an informational video for parents.  MNHI also provides in-person, hands-on training for maternity staff, utilizing realistic simulators.  Obstetricians who are experienced users of OdonAssistTM lead the training sessions. 
How was OdonAssistTM tested?
OdonAssistTM was designed with extensive input from doctors, midwives, engineers and specialists in medical technology, and underwent testing in simulated and pre-clinical research.  Following this, three clinical studies investigated the use of the device with mothers and babies, including follow up after birth.  Additionally, one qualitative study researched the opinions and experiences of mothers.  In 2025, OdonAssistTM obtained CE Mark certification, which allows for commercial distribution in countries that recognize the CE Mark.
How can OdonAssistTM be purchased?
OdonAssist™ is currently available for sale in certain European countries.  In countries where OdonAssistTM is available for sale, customers can purchase it directly from MNHI by sending an email to customercare@mnhi.com. To find out if OdonAssistTM is available in your country, send an email to customercare@mnhi.com.
How do you see OdonAssistTM transforming patient care?
OdonAssistTM is designed to enable obstetricians to assist vaginal birth, increasing ease of use and potentially avoiding risks and complications that can result from use of other assisted vaginal birth (AVB) devices.

MNHI envisions a time when OdonAssistTM may enable clinicians to increase use of AVB procedures and reduce costs and complications of childbirth by offering a new and safe alternative to C-sections. An increased use of AVB procedures could have an important impact on reducing maternal and newborn mortality in countries where women’s access to caesarean section procedures or AVB is affected by economic and geographic factors.16

Contact us

For general inquiries regarding MNHI or the OdonAssistTM, get in touch:
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Corporate Address:

Maternal Newborn Health Innovations, PBC
2001 Route 46, PMB 355
Parsippany, NJ 07054

Legal Manufacturer Address:

Maternal Newborn Health Innovations Singapore Pte Ltd
298 Tiong Bahru Road, #05-01
Central Plaza, Singapore 168730




Email Address for General Inquiries:

support@mnhi.com

If you have experienced an issue using OdonAssist™, contact MNHI at customercare@mnhi.com
*Please note we will not offer medical advice, respond to solicitations, or release company or employee information.
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