As we take a look at the devices that received FDA clearance in 2016's third quarter, we're also considering that the last few months have been a time of change at the Food and Drug Administration, as regulators are beginning to make updates in their system to accomodate all the digital health tools we're seeing.
In June, the FDA offered up a draft guidance document designed to help medical device makers better understand how the agency thinks about a patient's right to access their own data from a device. The guidance clarified that medical device makers can make a patient's data available to them without additional clearance, though it cautioned them to do so thoughtfully to keep the data private and secure. That prompted a number of industry and patient groups to respond to the draft guidance, with the chief company that there wasn’t enough clarity in the guidance. Read more about that here.
The FDA's Center for Devices and Radiological Health has also been busy over the last couple of months, releasing several draft and final guidance documents that affect the makers of apps and connected devices. Lack of regulatory clarity is often cited as a force hampering innovation in digital health, so these moves by the FDA toward greater clarity are likely to be welcomed in many parts of the industry. More
Most of the FDA-cleared devices or apps were for diabetes management. Of the seven clearances we tracked, two were for other health conditions. Medtronic had two pieces of news around its connected diabetes efforts: an FDA clearance for a hybrid closed loop insulin delivery system and the first test cohort of its Sugar.IQ app, created in collaboration with IBM Watson.The FDA approval of Medtronic’s MiniMed 670G hybrid closed looped system was announced by the FDA itself, as it’s the first automated insulin delivery system to get clearance by the agency. More
Medtronic also received a CE Mark for its Guardian Connect mobile continuous glucose monitor (CGM) and app. The company will begin selling the system in select countries in Europe, Asia, and Latin America in Q2 2017 and expects to receive FDA clearance to launch the device in the US around that same time. The Dublin, Ireland-based company already has an FDA and CE cleared connected CGM called Minimed Connect, but that system is for users of both a Medtronic CGM and the company's insulin pump. A Medtronic spokesperson explained the difference between the two systems in an email to MobiHealthNews. More
Ascensia Diabetes Care, a new business unit created this year when Panasonic Healthcare Holdings acquired Bayer Diabetes Care, has announced the launch and FDA 510(k) clearance of its Contour Next Link blood glucose monitor. Ascensia makes a line of connected and non-connected fingerstick glucometers. The Contour Next Link is a version that sends data wirelessly to Medtronic's MiniMed 630G insulin pump. According to Ascensia, it's the only FDA-cleared glucometer that connects to that pump, a new Medtronic offering that also just launched today. More
Companion Medical, a stealthy San Diego-based company that received funding last year from Eli Lilly and Company, has received FDA 510(k) clearance for its Bluetooth-connected smart insulin pen and associated mobile app, called InPen. "FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care," CEO Sean Saint, a veteran engineer of Dexcom, Medtronic, and Tandem Diabetes Care, said in a statement. "The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increased confidence that diabetes is being managed optimally. We are excited to be the first to introduce this entirely new class of insulin delivery." More
Abbott received FDA Clearance for its FreeStyle Libre Pro system, a key milestone in bringing the company's unique take on the continuous glucose monitor to the United States. In Europe, where the system has had CE Mark clearance since September 2014, there is both a prescription and over-the-counter version available and the latter is smartphone compatible.The FreeStyle Libre system is notable because it doesn't require fingersticks to calibrate and it has a lower cost than other CGMs on the market. The user wears a tiny insertable sensor and a patch on their arm for up to 14 days. The patch records glucose data every 15 minutes and uses NFC technology to transmit the data. More
An FDA advisory panel has voted in favor of recommending a change to the intended use of Dexcom’s G5 Continuous Glucose Monitor (CGM). The G5 had already been FDA-approved, but with limitations as an adjunctive device, meaning it could only be used for tracking and trending interstitial fluid gluocose concentrations rather than as a full replacement for a traditional fingerstick blood glucose meter (BGM). If the agency follows the panel's recommendation, the San Diego, California-based Dexcom will be able to market the G5 as a CGM patients can actually base treatment decisions on rather than a complement to the BGM. To support the potential use of the G5 under the new labeling, Dexcom provided clinical data from trials of its G4 CGM (which uses an identical glucose sensor and the same algorithms) prior to the FDA meeting. More
Analytica's PeriCoach, a smartphone-connected Kegel exercise coach for women, received a second FDA 510(k) clearance, one that allows it to be sold over-the-counter. Its previous clearance, from March of last year, was for prescription use only. Analytica is an Australian company and the device, which is also called a pelvic floor exerciser, was already available over the counter in Australia and the UK. It's cleared to be marketed to eliminate bladder leakage, or Stress Urinary Incontinence, a condition the company says affects one in three women. More
AirStrip, which makes a suite of mobile monitoring apps, received FDA 510(k) clearance for a web app version of AirStrip ONE, the company’s mobile interoperability platform. The company also recently received a patent for one of its functionalities within AirStrip ONE, an ECG waveform interpretation that acts as visual calipers for clinicians to make measurements on digital waveforms. Previously, the company has received clearance for its AirStrip Remote Patient Monitoring Solution, and its AirStripOB was one of the very first FDA-cleared medical apps in the AppStore. More
And here’s one more that hasn’t gotten FDA clearance yet, but believes that’s in the cards soon. Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, announced preliminary results from its US pivotal trial, a major step toward receiving premarket approval from the FDA, on the same day as the company's second quarter earnings call. More