A total of 11 digital health products received FDA approval in Q1 2021, compared to 14 in Q4 2020, according to Mercom Q1 2021 Digital Health Funding & M&A Report.
Since Q1 2017, a total of 263 digital health products have received FDA/CE approvals. Click here to learn more.
The digital health companies focused on Wearable Sensor Devices received the most FDA approvals during Q1 2021. Mobile Wireless Devices, Data Analytics, and Clinical Decision Support products received two FDA approvals each. Medical Imaging Software and Remote Monitoring categories also received one FDA approval each in Q1 2021.
Notable FDA approvals during Q1 2021
Ava, a digital health company, focused on women’s reproductive health, received FDA clearance for its Ava Fertility Tracker, a fertility tracking sensor bracelet and accompanying app. The machine learning-powered bracelet is designed to help women in ovulation prediction and facilitation of conception. It is worn only during sleep; it provides women with real-time, personalized information about fertility, pregnancy, and general health – delivered in a way that is convenient and non-invasive. Ava is backed by over $30 million funding from investors including btov, SVC, DCM Ventures, Khosla Ventures, and Innovation Endeavors.
Masimo, a medical technology company, announced the CE marking of the Rad-G with Temperature, a wireless device for clinicians to quickly assess patients and make informed care decisions about pulse oximetry and vital signs. The device also provides clinically proven SET pulse oximetry, respiration rate from the pleth (RRp), and other important parameters alongside clinical-grade, non-contact infrared thermometry.
Theranica, a company developing electroceuticals for migraine and other pain conditions, received the FDA clearance for its flagship product Nerivio, a smartphone-controlled prescription wearable device for acute migraine treatment of episodic or chronic migraine in people 12 years and older. Nerivio is worn on the upper arm for 45 minutes and utilizes Remote Electrical Neuromodulation to activate the brain’s native Conditioned Pain Modulation mechanism to treat pain and associated migraine symptoms. Theranica is backed by over $35 million from aMoon Fund, Lightspeed Venture Partners, LionBird, Corundum Open Innovation, Takoa, and other investors.
Quibim, a medical imaging analysis company, received 510(k) clearance from the FDA for its prostate AI-based Magnetic Resonance (MR) solution. The solution aids in prostate magnetic resonance imaging reporting from visualization to quantification while increasing diagnostic accuracy and, potentially, early prostate cancer detection. Quibim has raised over $10 million funding to date from Amadeus Capital Partners, Adara Ventures, Apex Ventures, Partech, Crista Galli Ventures, and Tech Transfer UPV.
Aidar Health, a health assessment monitoring device maker, received CE Mark approval for its wireless vital signs monitoring system, MouthLab. MouthLab measures 10+ vital health parameters, including oral temperature, non-invasive blood pressure, respiratory rate, respiratory flow cycle morphology, pulse rate, ECG, oxygen saturation, heart rate, heart rate variability, and lung functions in 60 seconds.