This quarter was another busy one for the FDA as it continued to reevaluate its approach to digital health amidst a changing of the guard from Dr. Scott Gottlieb to its new commissioner, Dr. Norman "Ned" Sharpless.
Among its most notable digital health actions of the past few months was the agency’s decision to put out a call for new companies to try out the current framework of its Digital Health Software Precertification Program, the ongoing effort to streamline regulation of digital health products prone to frequent update.
Organizations that are expecting to sponsor either a 510(k) submission or De Novo Request for software as a medical device (SaMD) during 2019 or early 2020 are eligible to volunteer, although the agency wrote in its notice that it doesn’t plan to award precertification to those that complete the test process.
While many companies were enthusiastic about participating in the original PreCert program, the industry reaction to the new call out has been a mixed bag, as there are still a lot of unknowns.
“Regarding new companies that might want to join, some of the benefits are you’re not going to get a faster, streamlined review at this point, but you will get a teaser for once precertification is opened up more broadly,” Lesley Maloney, head of US regulatory policy and a digital strategy lead at Pre-Cert participant Roche Diagnostics, said during a panel at BIO 2019 in Philadelphia. “What does that mean? [It’s] what types of questions the FDA is going to ask; what are the types of elements, the dashboard I need to create in order to share this data and demonstrate I’ve met the five principles they’re looking for. So pros and cons if you wanted to volunteer, but I understand FDA’s goal to want more data points, especially as others are looking very closely — other regulators globally — at this program to see, at the end of the day, does this work?”
Pharma execs at BIO also questioned what the focus on real-world evidence and post-market data would look like.
Aside from the PreCert program, the agency has continued its role in regulation.
In June the FDA issued a warning to patients and providers warning of the dangers of diabetes management devices and software that haven’t been assessed by the agency.
In early April the agency released a 20-page exploratory whitepaper on how it could address artificial intelligence and machine learning algorithms.
“As algorithms evolve, the FDA must also modernize our approach to regulating these products,” an outbound Gottlieb wrote in a statement at the time. “We must ensure that we can continue to provide a gold standard of safety and effectiveness. We believe that guidance from the agency will help advance the development of these innovative products.”
This included any unapproved or unauthorized continuous glucose monitors, insulin pumps and automated insulin dosing systems, whether used as a standalone device or integrated as part of a glucose management system.
Of course, the agency has also been busy clearing new items for use. Read on for a list of products cleared by the agency in Q2, in chronological order.
AliveCor received an FDA clearance for its existing KardiaMobile and KardiaStation platforms that allow consumers and point-of-care users to receive more information about their mobile ECG readings.
Now, when consumers or clinicians conduct an instant analysis ECG test using AliveCor’s devices, the software will no longer surface an “unclassified” result when the reading is between 40-50 beats per minute or 100-140 beats per minute, Dr. Jacqueline Shreibati, chief medical officer at AliveCor, explained to Luisbrandao. Rather, the former reading now generates an indication that the user is experiencing bradycardia while the latter produces a result for tachycardia.
After landing FDA clearance for clinical use of its AI-enabled device and platform for in-hospital remote patient monitoring back in February, Edinburgh, Scotland-based Current Health (formerly snap40) announced it also got the greenlight to be used in the acute care setting.
The company is called this decision “the first-ever FDA clearance for end-to-end, real-time, passive [remote patient monitoring] wearable and platform.”
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced in April that it received an 510(k) clearance for an AI tool that can read medical imaging to identify potential cases of pneumothorax — a build-up of gas between a lung and the chest wall.
In May the FDA granted digital physical therapy company Reflexion Health a 510(k) clearance for its Virtual Exercise Rehabilitation Assistant (VERA) to be used for trunk and upper extremities.
VERA is a prescription digital physical therapy platform that uses an avatar coach to help patients with their rehabilitation. The platform has the ability to perform a 3D scan of the patient in order to measure their movement and analyzes their functional assessment. Patients and providers are also able to view a user’s progress and statistics on a dashboard.
The FDA cleared eMurmur ID, a software screening device that uses a smartphone, third-party digital stethoscope and machine learning to automate the detection of heart murmurs.
According to Ottawa, Canada-based eMurmur, the cloud tool identifies and classifies both dangerous and healthy heart murmurs, as well as the absence of a murmur and S1 or S2 heart sounds. The platform includes a mobile app, web portal and artificial intelligence analytics features, and is designed to fit into the workflow of healthcare providers. Recordings of heart sounds can also be securely shared with other experts for consultation.
Aidoc, an Israeli provider of artificial intelligence products for radiologists, announced today that it has received FDA clearance for a tool that identifies potential cases of pulmonary embolism — a blockage in one of the lung’s pulmonary arteries — for expert review.
Later that month Theranica, an Israel-based biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, announced that the FDA granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, utilizing remote electrical neuromodulation for the acute treatment of migraine.
Zebra Medical Vision scored another FDA clearance, this time for an AI triage tool for intracranial hemorrhage. Called HealthICH, the software product reviews non-contrast head CT scans to highlight potential bleeds for radiologist review.
According to the company, the tailor-made neural network is capable of generating these alerts in spite of smaller bleed sizes and more common artifacts, such as metal, that are observed within a patient’s brain.
In June Aidoc also locked down yet another FDA clearance for its tool that triages cervical spine fractures. Much like the company’s prior offerings, the new product analyzes images to prioritize high-risk cases for review by a radiologist, and does so within the specialist’s existing clinical workflow.
In early June implantable CGM company Senseonics announced that it received approval from the FDA for the non-adjunctive indication for its Eversense device.
Senseonics is only the third company to secure this indication, which allows a CGM to be used for insulin dosing in lieu of a fingerstick glucometer, though patients will still need to use fingersticks twice a day for calibration.
Caesarea, Israel-based Itamar Medical received FDA 510(k) clearance last week for a new disposable home sleep apnea test (HSAT) called WatchPAT One.
The device is smartphone connected; patients pair the wearable to their phone before sleeping with the device, which straps around the wrist but also includes a sensor that goes over the tip of the finger and another that affixes to the chest, both physically connected to the wrist strap by wires.
Lastly, FDA granted De Novo clearance to a prescription nerve stimulation device for the reduction of functional abdominal pain. The device is intended for use by adolescents and teens with irritable bowel syndrome in combination with other therapies.
Developed by Innovative Health Solutions, the IB-Stim devices is a single-use electrical nerve stimulator. When placed behind the patient’s ear, it emits low-frequency pulses over the course of five days, after which it can replaced by a new device for up to three consecutive weeks. By doing so, the device stimulates certain cranial nerves that appear to provide pain relief for these patients.