Brainstorming, smart design, and clinical validation are all vital steps toward the deployment of any new health technology, but without regulatory approval many of the most groundbreaking innovations will never have a chance to make an impact on patients and consumers.
In the US, these processes could see some shakeup in the future — FDA Commissioner Dr. Scott Gottlieb has been consistently outspoken about his efforts to streamline approvals for new devices and software, and the agency’s experimental pre-certification program is exploring a new model for companies looking to bring devices to market.
Regardless, the large majority of health technology innovators are still contending with the tried-and-true 510(k) and De Novo pathways for their novel digital health products.
Below is a collection of 31 FDA approvals and clearances so far in 2018:
De Novo clearances
The FDA announced in February that it will permit marketing of Viz.ai’s Contact, a clinical decision support (CDS) tool that analyzes CT results and highlights cases that may have experienced a stroke. The CDS application was submitted through the agency’s De Novo premarket review pathway, and as such creates a new regulatory classification for similar AI-driven platforms to come. (The FDA’s decision came just a couple of months after the agency released its long-awaited, and somewhat controversial, draft guidance on CDS outlining which tools would and would not be regulated by the agency.)
In April the FDA granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR. This decision marks the first AI-based diagnostic system to be authorized by the FDA for commercialization in the US that can provide a screening decision without the need for clinician interpretation, according to the agency. The pivotal trial data upon which the agency based its clearance was recently published in npj Digital Medicine, alongside an editorial expression some doubts about the robustness of the data.
Isreal-based DreaMed Diabetes was granted a de novo request for its AI-powered software for providers managing patients with Type 1 diabetes. The cloud-based DreaMed Advisor Pro is a diabetes treatment decision support product that analyzes data from continuous glucose monitors, insulin pumps, and self-monitoring to determine an insulin delivery recommendation.
Connected health company Fresca Medical was granted De Novo authorization to market its Curve device, a positive airway pressure delivery system that treats obstructive sleep apnea. The Curve includes a flow generator, a lightweight and ergonomic air delivery hose, and a nasal pillow. The company said the device is different from typical CPAPs because of its SmartValve technology, which it noted uses less airflow than other systems and could lead to higher rates of adherence for those with sleep apnea.
Natural Cycles’ contraception app received US marketing approval for pre-menopausal women aged 18 years and older. Previously approved in the UK and currently the subject of investigation by multiple regulatory agencies, the algorithm-driven app helps users track their menstrual cycle and informs them when they are most fertile. By taking their temperature in the morning and submitting additional information about their cycle, the app’s algorithm generates insights about the user’s daily fertility.
Apple furthered its push into the consumer health tech market when it announced during its annual keynote De Novo clearance for an ECG built into the Series 4 Apple Watch. The new devices will include electrodes on the digital crown and the back of the Watch. It takes about 30 seconds for a user to take an ECG, which is then stored in Apple's Health app, according to the company. This means, via Apple Health Records, some users will also be able to send readings directly to their doctors.
Apple also received clearance for an algorithm able to detect atrial fibrillation. Alongside the ECG, it allows the Watch to screen users' heart rhythm in the background and send notification if it detects an irregular rhythm that appears to be atrial fibrillation.
Digital diabetes care company Glooko announced that its Mobile Insulin Dosing System (MIDS) — an app-driven tool that recommends insulin dose adjustments using data collected directly from a patient’s blood glucose meter — has been cleared by the FDA. The MIDS module allows clinicians to create a customized treatment plan and send it to Type 2 diabetes patients directly through the company’s unified mobile diabetes management app. Instead of relying on patients to input their own fasting blood glucose, however, the system pulls readings from the patient’s blood glucose meter.
Medtronic has received a handful of FDA wins this year, the first of which was an expanded indication to the Guardian Sensor 3, allowing patients to wear the sensor on their upper arm. The sensor is part of Medtronic’s MiniMed 670G system, and is currently the only continuous glucose monitor approved by the FDA to control automated insulin delivery via a hybrid closed loop system. Along with the added convenience of the new sensor site, the company said in a statement that the new location is also more accurate, demonstrating a mean absolute relative difference (MARD) of 8.7 percent following calibration.
Medtronic also received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. The Guardian Connect system consists of the Guardian Sensor 3 and attached transmitter, which sends continuously-collected glucose data via Bluetooth to the Guardian Connect app on a user's smartphone. The app can alert patients about high or low blood sugar 60 minutes in advance of a hyper- or hypoglycemic event.
Children with Type 1 diabetes will also now have access to the Medtronic MiniMed 670G, a hybrid closed-loop system insulin delivery system following the FDA’s decision to expand the product approval for a younger demographic. In 2016 the device became the first FDA-approved continuous glucose monitoring system that controls automated insulin delivery via a hybrid closed loop system. But at that time it was only cleared for patients over the age of 14. This new clearance now opens up the product to kids between the ages of seven and 14.
Finally, Medtronic also landed FDA clearance for its Deep Brain Stimulation (DBS) Clinical Programmer and ActivaProgramming application. The new applications work with DBS systems, which are surgically implanted into a patient’s brain to deliver electrical stimulation to precisely targeted areas of the train, according to a statement. The ActivaProgramming Application was designed to streamline workflows and provide actionable information to neurologists and neurosurgeons who are treating patients using Medtronic’s Activa DBS system.
Dexcom received its long-awaited nod from the FDA to market the Dexcom G6, an integrated continuous glucose monitoring system (iCGM), making it the first interoperable CGM to get the designation. As of today, the Dexcom G6 is the only FDA-authorized iCGM that can integrate with other compatible medical devices and electronic interfaces, such as automated insulin dosing systems, insulin pumps, blood glucose meters, or other electronic devices used for diabetes management, according to a statement released by the FDA.
Billerica, Massachusetts-based Insulet Corporation, maker of the OmniPod Insulin pump, scored FDA clearance to commercialize its latest product the Omnipod Dash Insulin Management System. The Omnipod Dash includes a tubeless, wearable insulin pump that can continuously deliver insulin therapy through basal rates and bolus amounts, according to the company’s webpage. The Dash system also includes a handheld Personal Diabetes Manger with a touchscreen, which connects to the pod via Bluetooth.
At long last Eversense, the implantable continuous glucose monitoring system from Senseonics, received FDA clearance to be marketed in the United States. The company has been waiting on this clearance since November 2016. The approval very significant for the company, which is already selling its second-generation device in Europe, the Middle East, and Africa.
University of Stanford spinout PhysioWave received FDA clearance for its pulse wave velocity (PWV) cardiovascular analyzer scale, which measures the stiffness of the vessels transporting blood from the heart to the body. The new technology will come in the form of a scale. The new scale, called the PhysioWave Pro, also measures pulse rate, weight, and BMI, and according to the website uses a dedicated tablet as user interface. The company claims that its technology is able to identify when someone is at high risk of cardiovascular disease.
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision received FDA 510(k) clearance for an algorithm that helps physicians quantify a patient’s coronary artery calcification. From a ECG-gated computed tomography (CT) scan, the Coronary Calcium Scoring algorithm automatically calculates a calcification rating equivalent to those derived using the Agatston Coronary Artery Calcium Scoring method.
Plano, Texas-based MediLynx, the US subsidiary of Poland's Medicalgorithmics, received FDA 510(k) clearance for its PocketECG CRS Mobile Cardiac Rehabilitation System. The product is a new application of the company's existing (and previously FDA-cleared) PocketECG technology, which can monitor cardiac patients for arrhythmias remotely for up to 30 days. The device captures the full ECG signal and streams it via a cellular network to an online monitoring platform and physician portal. The device also includes a built-in accelerometer and a touch screen that allows patients to report symptoms — allowing caregivers to see how ECG, activity, and symptom data interact over time.
Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA in January. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that has led it up to this milestone. The clearance is not over-the-counter, which means users will have to secure a prescription from their neurologist to use the device's seizure-detecting features.
New York and Palo Alto, California-based MemoryMD received FDA clearance for NeuroEEG, a wireless amplifier that transmits EEG signals to computers and cloud-based databases via Bluetooth. The other half of MemoryMD's offering, a disposable EEG cap called NeuroCap, is still awaiting clearance.
Cerebrovasular imaging company iSchemaView has received the FDA nod for its latest product the Rapid CTA, a 3D imaging platform for computed tomography angiography (CTA). CTA scans are used to help clinicians visualize their patients' cerebral arteries, usually if a patient has experienced a blood clot, according to the company. But interpreting the standard output can be a time-consuming process, it said.
New York and Palo Alto, California-based MemoryMD landed FDA clearance for a disposable 19-channel EEG headset, called the NeuroCap. The system is meant to be used with the NeuroEEG, a wireless amplifier worn around the arm that transmits to computers and cloud-based databases via Bluetooth that was approved in February.
In June, Switzerland-based MindMaze received FDA clearance for the MindMotion Go, a gamified neurorehabilitation therapy platform for medium and light severity impairments able to be deployed in the patient’s home. Using motion capture technology based on the Microsoft Kinect, the Go engages patients with a range of activities set in displayed 3D environments that promote motor and task functions.
DyAnsys, a medical device company specializing in the autonomic nervous system, announced in mid-June that it has received FDA approval for a wearable auricular neurostimulation device designed to treat symptoms of opioid withdrawal.
Cleveland, Ohio-based SPR Therapeutics received FDA clearance for a new version of its percutaneous, wearable pain management device, the Sprint Peripheral Nerve Stimulation (PNS) system. With this, the system is now available as a single lead (Sprint endura) or dual lead (Sprint extensa) offering, with the latter allowing for the non-surgical placement of two lead wires that are connected to a single device. In addition, the updated platform now supports rechargeable batteries and a Bluetooth-enabled controller for patient use.
Remote monitors, and other clearances
toSense’s CoVa Monitoring System 2, a remote patient monitoring necklace that tracks vitals and cardiac fluids, received its second FDA clearance early in the year. The latest decision will allow the company to update the software to add a new feature that measures stroke volume and cardiac output to the original product. The clearance also lets the device connect to a mobile application that allows medical professionals to remotely view measurement data and single-lead ECG waveforms.
Smart thermometer and connected health company Kinsa launched a new wireless version of its device, called Kinsa QuickCare, after securing FDA clearance. The QuickCare thermometer can read temperature in eight seconds — down from 10 seconds for the old model. It preserves most of the software features in the original Smart Stick, including Kinsa’s partnership with Sesame Street and the bubble game that was introduced with the original device to distract children while the thermometer does its work.
Early in the second quarter smart inhaler company Adherium received a 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort. Adherium makes a device that grafts onto a patient’s inhaler to monitor and encourage medication adherence as part of a self-management plan. It is designed to be easy to install and remove, and includes three buttons that help patients access the audio-visual reminders, battery monitoring, and Bluetooth low-energy pairing features. The inhaler can also help clinicians pinpoint when and how someone is misusing an inhaler, for instance holding it upside down or inhaling at the wrong time.
(A few months later, Adherium would also receive over-the-counter clearance for additional versions of its product specific to ProAir HFA, Ventolin HFA, and Flovent HFA inhalers.)
Cambridge, Massachusetts-based sensor maker MC10 received its first FDA 510(k) clearance for the BioStamp nPoint system. BioStamp nPoint is a more advanced version of the company's non-FDA cleared BioStampRC. The system consists of reusable adhesive sensor patches that can monitor users for 24 hours at a time. The sensors record vital signs like movement and heart rate and display them on an Android phone also provided by MC10. The system is designed to be used at home or in the clinic.
Tel-Aviv, Israel-based Healthy.io secured FDA 510(k) clearance for dip.io, a home-based urinalysis kit that turns a smartphone into a clinical-grade diagnostic device. The kit contains detailed instructions for home testing and disposable test strips and testing cups, but the major innovation is a panel of patterns and colors that allows the smartphone camera to accurately read the test strip regardless of lighting or environment. This means that unlike many existing at-home lab kits, patients don't have to mail anything back, and they can get results right away.
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