Fantastic to have FDA recommendation, need obstetric, midwifery...

Fantastic to have FDA recommendation, need obstetric, midwifery and health insurance to recommend use to really see some progress for HMD. Hopefully they have prepared with increased manufacture of devices so they can meet supply.



New FDA recommendations for Fetal and Maternal monitors during Covid-19
• The US Food and Drug Administration (FDA) released updated guidance for the use of Non-Invasive Fetal and
Maternal Monitoring Devices Used to Support Patient Monitoring during COVID-19 which encompasses HMD’s
fetal heart rate monitor, HeraBEAT.
• According to the FDA enforcement policy, lay users (e.g., patient, or caregiver) could now be instructed to use
Fetal dopplers in a home setting under the direction of a health care provider via prescription.
• Only devices under specific codes which previously received FDA clearance for professional use are included
under the new guidelines.
• The HeraBEAT device received FDA 510(k) clearance for prescription use by medical professionals on the 18th
November 2019 (K191110), and can now expand its cleared indications for use to allow the device to be used by
a lay user in a home setting under the direction of a health care provider, without a prior 510k submission.
• ‘FDA believes the policy set forth in this guidance will help address these urgent public health concerns by
helping to expand the availability and capability of non-invasive fetal and maternal monitoring devices.
Modified use of these devices may increase access to important prenatal data without the need for in-clinic
visits and facilitate patient management by health care providers while reducing the need for in-office or inhospital services during the COVID-19 public health emergency. Increased utilization of non-invasive fetal and
maternal monitoring devices may ease burdens on hospitals and other healthcare facilities and reduce the risk
of exposure for patients and health care providers to SARS-CoV-2. ‘
• Release of FDA new guidance expands HMD capabilities and allows the sales of the HeraBEAT device in the US
for home use by the pregnant woman, following the launch of its US market entry strategy.
• HMD is poised to deliver material operational progress and expedite commercial deployment during the COVID19 period and beyond.