Ten FDA-Approved Medical Apps from H2 2015 File for IPO
In the first half of 2015, VCBeat published an article titled “10 Medical Apps Approved by the FDA in the First Half of 2015”, a total of 10 medical apps approved by the FDA were identified, primarily consumer-oriented products spanning ten specialized sectors. Will the FDA continue its consumer-focused approach and cater to the mass market in the second half of 2015? A comprehensive online search by VCBeat revealed another 10 apps in the latter half of the year, as detailed below.1.G5 Mobile CGM SystemIt is the first FDA-cleared continuous glucose monitor designed for 24/7 wear. Its principle is straightforward: utilizing wireless Bluetooth technology integrated into the sensor, the G5 Mobile Continuous Glucose Monitoring System directly transmits monitoring data to a mobile app.
This app is suitable not only for adults but also for children around two years of age. In addition, the G5 system allows up to five individuals to remotely monitor a patient’s blood glucose levels. If abnormal blood glucose readings are detected, the system will send alerts to these users. However, fingerstick blood testing remains necessary for determining insulin dosages and calibrating the system.
The Android version is expected to be released early this year.2.MyCareLinkMyCareLink is an app launched by Medtronic for remote monitoring of implanted pacemakers. This monitoring system is a handheld, portable device that connects the pacemaker to its companion app, enabling communication between patients and physicians. Notably, data on patients’ cardiac rhythm abnormalities are automatically transmitted to the connected physician within a secure internet environment.
3.spinal cord stimulation systemIt is a spinal cord stimulation system developed by St. Jude Medical for the treatment of chronic back pain. Its most distinctive feature is that it does not require recharging, making it the only non-rechargeable spinal cord stimulation system available to date.
This system is designed to work in conjunction with a mobile application developed by the company. The app is a clinical tool used to adjust stimulation therapy, and patients can also utilize St. Jude Medical’s Invisible Trial System to evaluate the treatment; this invisible trial system offers an unlimited neuromodulation program.This new spinal cord stimulation system significantly benefits both patients and physicians by providing patients with an optimal, low-maintenance therapy tailored to their needs. It helps minimize disruption to daily activities for both doctors and patients, while also enabling follow-up treatments without the need for additional surgery.4.iViz（Cigital）iViz is an intelligent ultrasound examination tool developed by FUJIFILM SonoSite in Japan for clinical medical applications.It consists of an examination device and a display. The device is suitable for ultrasound examinations of the abdomen, heart, lungs, and other areas, as well as obstetric (OB) scans. For convenient viewing, it is equipped with HDMI and USB interfaces, allowing connection to electronic medical records and other online systems.
Furthermore, physicians can access learning resources and patient information, store examination results, submit reports, and provide real-time remote assessments. This is particularly beneficial for point-of-care applications and telemedicine consultations, achieving a new level of imaging performance and providing unprecedented high connectivity.It is reported that the product received CE certification in September of the same year.5. MedwatcherMedWatcher is an application developed through a collaboration between Epidemico and the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).
MedWatcher is designed to provide users with news and official warnings regarding pharmaceuticals, vaccines, and medical devices. It is currently the only app that enables you to directly report side effects or adverse reactions to the FDA, thereby influencing physicians’ prescribing practices.6.Eko Core
The Eko Core is a stethoscope developed by the Silicon Valley startup Eko Devices. It records patients’ heart sounds and transmits them to a mobile application. Additionally, the Eko app is the first HIPAA-compliant mobile application that supports electronic health records (EHR).Furthermore, Eko Devices is developing an algorithm designed to assess patients’ overall cardiac status.7. nfantNFANT Labs, based in Atlanta, Georgia, spent two years developing a smart bottle capable of measuring infant tongue strength. It is the first and only medical device that can measure tongue movement during infant feeding while simultaneously capturing and transmitting data to caregivers.
This medical device includes a disposable coupling unit placed between the pacifier and the baby bottle. Connected to sensors, it non-invasively measures the infant’s tongue strength and transmits the data to a corresponding app via low-energy Bluetooth.8. Corporate Dental Imaging (CDI) ApplicationCorporate Dental Imaging (CDI) is an application developed by the U.S. Army Dental Command (DENCOM). It is used to control the capture, display, transmission, enhancement, and storage of dental X-ray images obtained from digital imaging systems.
The CDI app is an equivalent device to XELIS DENTAL, with the original applicant being INFINITT CO., LTD. This application is advanced 3D reconstruction software that can be used independently and seamlessly integrated with the INFINITT DENTAL PACS system. Its software package provides precise measurements and anatomical information for all oral and maxillofacial structures. This three-dimensional treatment planning tool significantly improves work efficiency, assisting clinicians in making better diagnoses and delivering more effective treatments.9.PowerDot(R) PD-01 Muscle StimulatorIt is a wearable fitness EMS (Electrical Muscle Stimulation) device. It is designed to stimulate healthy muscles to improve or enhance muscle performance.
The PowerDot app features a range of pre-set programs designed to meet the training needs of professional athletes and fitness enthusiasts at all levels. According to the official statement, just 20 minutes per session can comprehensively enhance users' muscle performance.10.DarioThis is a blood glucose monitoring system designed by the Israeli innovation company LabStyle. The system provides a cloud-based platform for blood glucose management for diabetic patients, which can record readings and help interpret the results.
Through the app, patients can share their blood glucose results with caregivers, physicians, or family and friends for review and receive treatment recommendations. Patients can also use it as a log to record information such as medication usage, carbohydrate intake, and daily activities.●The 10 approved medical apps are distributed across nine sub-sectors, with two apps in the blood glucose monitoring category.
●Business Model: B2C (8 companies), B2B (2 companies); both B2B companies serve the physician community at healthcare institutions.
●Physicians constitute the primary user base, accounting for 54% and surpassing “consumers,” who were the main target audience for products approved by the U.S. Food and Drug Administration (FDA) in the first half of 2015. Furthermore, in the second half of the year, 38% of the approved products were patient-focused. Under the FDA’s notoriously stringent review process, the technical capabilities of internet healthcare products are on the rise.
Appendix: Summary of Apps Approved by the FDA in the Second Half of 2015
