FDA clearance

By Mallory Hackett 09:18 am July 7, 2020
Cochlear Limited announced yesterday the U.S. Food and Drug Administration clearance of three new products to be added to the company’s suite of hearing technology devices, all of which can connect to smartphones. The Premarket Approval clearances went to the Kanso 2 Sound Processor, the Nucleus 7 Sound Processor for Nucleus 22 Implant recipients and the Custom Sound Pro fitting software. The new...
By Laura Lovett 04:07 pm March 11, 2020
Women’s health company Proov got the FDA green light for its at-home ovulation testing kit.  Users can send away for the kit and get test strips, which can determine the presence of progesterone metabolite PdG in urine, which is linked to a woman's ovulation cycle.  The test was developed to help women find out if they are ovulating on a regular basis.  In the spring, the company will roll out...
By Laura Lovett 01:41 pm March 2, 2020
Last week the FDA greenlighted the ultrasound app VistaScan from Emagine Solutions Technology.  The new software app can be used on a doctor's cellphone or tablet. It can also connect with companion ultrasound probes, which are already FDA cleared.  The company previously partnered with the Red Cross to assist women with prenatal scans, according to a video on the company’s website. WHY IT...
By Laura Lovett 01:36 pm February 3, 2020
Sony’s smart operating platform NUCLeUS Operating Room scored FDA 510(k) clearance late last week. The new system allows clinicians to capture, store and share OR videos, scans and other patient data throughout its hospital network. This will also allow videos, including 3D videos, to be captured in "near real time.” The latest tool was designed to reduce hardware requirements in the operating...
By Laura Lovett 11:51 am January 28, 2020
This morning digital cardiac health startup Eko announced that its atrial fibrillation and heart murmur detection algorithm landed a 510(k) FDA clearance. The new algorithms are designed to integrate with Eko’s stethoscope, which is already on the market, and be used by healthcare providers.  The company said it plans to add more algorithms in the future. Next up will be an ECG-based algorithm...
By Laura Lovett 03:16 pm January 23, 2020
Wearable sensor company VivaLNK got the FDA nod for its Multi Vital ECG Sensor and software development kit (SDK) this morning.  This comes roughly a month after the technology landed a CE Mark, allowing the product to be marketed in the European Union.  The new product, which includes a light weight reusable sensor and corresponding SDK, allows developers and providers to have direct control...
By Dave Muoio and Laura Lovett 09:13 am December 30, 2019
The back half of 2019 saw an FDA in the midst of a transition — both in terms of personnel and in digital regulation strategy.  On the former, the agency seems to finally be regaining its legs since the unexpected March resignation of its former head, Dr. Scott Gottlieb. After a rotating door of acting commissioners — consisting of Dr. Ned Sharpless from the National Cancer Institute and more...
By Laura Lovett 04:05 pm October 8, 2019
This morning the Dexcom G6 Pro Continuous Glucose Monitoring System got the greenlight from the FDA. The latest technology can gather real-time glucose data over a period of 10 days and has the ability to be switched to blinded mode or unblinded mode.  In blinded mode, patients don’t see their data automatically; instead, the clinician will get the data and then be able to discuss it with the...
By Dave Muoio 03:10 pm October 1, 2019
Sixth time's the charm? Roche’s Accu-Chek Connect Diabetes Management App has notched its sixth device recall from the FDA, this time due to meter-to-app data transfer issues for users with Android OS 8.0 and above. According to the agency’s posting, Roche notified partners, users and call centers of the issue and released and update addressing the problem before the end of that month. Prior to...
By Laura Lovett 03:14 pm July 15, 2019
This morning Teva Pharmaceutical Industries announced that the FDA greenlighted its AirDuo Digihaler, a sensor-enabled inhaler. The product, classified as a maintenance asthma inhaler, has a built-in sensor that sends usage data to a corresponding app on a user's smartphone. This information can also be sent to the user’s provider.  The sensor technology is also able to monitor inspiratory flow...