Ten FDA-Approved Medical Apps from H1 2015 File for IPO

In 2014, according to statistics from the VCBeat Internet Healthcare Research Institute, the FDA approved a total of 31 internet healthcare products, including 16 apps. In the first half of 2015, we conducted a separate review of medical apps and found that 10 had received FDA approval. If this trend continues, the number will surpass the total for 2014.

So, what advantages do they possess that have earned FDA approval? The following section provides a detailed introduction to these 10 apps, including their respective fields and target audience analyses.

1PeriCoach

PeriCoach is, in fact, a medical device that can connect to smartphones, and the company has also launched its corresponding app, PeriCoach.

Surveys indicate that one in three women experience bladder leakage, resembling symptoms of urinary incontinence, at various stages of life. This condition causes significant physical and psychological distress in daily life. Although experts recommend strengthening pelvic floor muscles to alleviate symptoms, 50% of women are unable to perform the exercises independently through verbal instructions or written manuals alone. PeriCoach is a device and app designed to enable women to conduct autonomous pelvic floor training at home.

The PeriCoach app is free, but the accompanying device requires an annual payment of $299.

This device features three biofeedback sensors. By squeezing the device, users can trigger the sensors to detect pelvic floor muscle contractions and rapidly transmit the data via Bluetooth to a mobile app. The app displays a continuous stream of information with real-time feedback and records user progress, facilitating communication with healthcare providers during medical consultations.

2ACCU-CHEK® Connect

ACCU-CHEK® Connect is a diabetes health management app developed by Roche Diagnostics. It tracks users’ diabetes status, automatically converts blood glucose data, and recommends insulin dosages based on carbohydrate content and blood glucose levels.

It also provides timely reminders for patients to measure their blood glucose levels and generates charts based on the results. Patients can input all data related to their condition, such as meal portion sizes, food types, caloric intake, insulin dosage, physical activity, medication usage, blood pressure, body weight, and health status, and can also insert images and notes.

By logging into their accounts, patients can share personal data via online devices, SMS, email, and with designated individuals, facilitating medical consultations. During diabetes treatment, ACCU-CHEK® Connect has become an invaluable assistant to physicians.

However, there was a minor episode: one month later, Roche would announce the recall of this app.

3Theranos

Patients visiting hospitals are typically required to undergo complete blood count (CBC) tests for disease diagnosis, with results usually taking anywhere from half a day to a full day. Theranos, however, enables blood testing to extend beyond the confines of traditional laboratories.
The current medical paradigm requires patients to undergo blood tests only after certain symptoms of a disease have manifested. Theranos advances this process by conducting tests before any signs of disease appear, with the aim of enabling early detection and early treatment.

Meanwhile, conventional testing is overly cumbersome; patients or physicians often require only one or a few specific tests. Theranos, by contrast, conducts targeted assays based on patient preference, thereby significantly reducing wait times and costs. Patients need only submit their samples to the nearest Theranos Wellness Center, after which the app delivers test results in the shortest possible time.

Rest assured, the test results transmitted to the app are highly confidential. Through the app, patients and physicians can detect subtle changes in certain values, enabling earlier disease detection.

4Sense 4 Baby

Sense4Baby was developed by the Gary and Mary West Health Institute (which was acquired by the mobile health solutions company AirStrip in early 2014). It comprises a suite of wireless devices and HIPAA-compliant cloud technology designed to conduct non-stress tests for pregnant women with high-risk pregnancies.

This device is simple and easy to use, equipped with high-sensitivity sensors that provide accurate real-time monitoring information for physicians and expectant mothers. Meanwhile, its wireless configuration enables physicians to receive feedback anytime and anywhere via smartphones or tablets, including physiological data such as fetal heart rate and uterine contractions, facilitating prompt clinical decision-making.

5TraumaCad Mobile

TraumaCad Mobile enables physicians to perform preoperative planning for Total Hip Replacement. With just a few simple steps, TraumaCad Mobile visualizes the procedure, allowing for rapid and straightforward simulation.

TraumaCad Mobile displays individual bone components, allowing physicians to accurately position the corresponding images via touch-screen interactions. This facilitates preoperative planning and saves valuable time for major surgeries.

All images on TraumaCad Mobile are precisely measured to ensure accuracy. Once the procedure is complete, the images can be stored in the cloud or the hospital’s medical imaging system for sharing and discussion with colleagues.

6myVisionTrack®

myVisionTrack® is developed by Vital Art and Science and is suitable for patients with a family history of diabetic retinopathy, dry AMD, and wet AMD.

For patients with degenerative eye diseases, self-testing is extremely challenging. With physician approval, patients can perform autonomous home testing twice weekly using a smartphone-based shape discrimination test. The results are uploaded to the physician’s portal to facilitate disease progression monitoring. The app also provides automated analysis and alerts physicians when necessary, enabling them to adjust treatment plans based on patient adherence.

Surveys indicate that myVisionTrack achieves a patient compliance rate of up to 86%, having undergone four clinical trials with over 500 participants.

7Triton Canister App

TritonCanister is an app developed by Gauss Surgical that estimates intraoperative blood loss.

In routine surgical procedures, anesthesiologists and surgeons often rely on visual estimation and experience to assess intraoperative blood loss, a method that is inherently imprecise. The Triton Canister uploads images via a dedicated surgical suction device to the cloud for analysis. It identifies container sizes and accurately quantifies blood loss and hemoglobin levels, providing reliable estimates to inform clinical decision-making—particularly regarding the administration of blood products—thereby significantly enhancing patient safety and overall care.

8Drug Shortage

Drug Shortage is a medication app launched by the FDA. It enables patients to access drug information more quickly, check whether a specific drug is currently in short supply, and avoid treatment interruptions caused by drug shortages.

The medication software launched by the FDA greatly facilitates public access to information about prescribed drugs, enabling patients to locate specific medications by type, brand, or even therapeutic class. For physicians, timely awareness of critical drug shortages is highly beneficial for clinical prescribing decisions.

9Dexcom Follow

Dexcom Follow, developed by Dexcom, Inc., is part of the Dexcom G4® PLATINUM System.

Dexcom Follow connects users with their loved ones—whether it’s a child studying away from home, elderly parents living in another state, or a cherished partner—by delivering blood glucose levels, trends, and other critical data to the user’s smartphone in real time.

With Dexcom Follow, users can not only monitor the health status of their key contacts anytime and anywhere, but also promptly receive shared information from others and respond quickly to targeted blood glucose alerts.

10HUB Telehealth

HUB Telehealth provides patients with 24/7 service. In case of an emergency, patients can log in to their HUB Telehealth account and contact a Teladoc physician via phone call or online video consultation.

All physicians at HUB Telehealth are board-certified in the United States. They listen to patients’ symptoms and recommend treatment plans, ensuring that all patient concerns are fully addressed by the end of each consultation. With patient consent, visit summaries can be forwarded to the patient’s primary care physician for reference. Surveys indicate that over 90% of patients believe HUB Telehealth fully resolves their health issues, delivering outcomes comparable to those of in-person medical consultations.

Based on the above analysis, we find that

● The 10 approved medical apps are distributed across 10 specialized subfields.

● Operational Model: App (6, including 2 with online services), App + Device (4)

● Customer service groups primarily serve consumers, including the general public (5 groups), patients (1 group), high-risk pregnant women (1 group), and women (1 group).

Appendix: Summary of Apps Approved by the FDA in the First Half of 2015



Text | Zhou Yanxun Editor | Mo Renying