FDA clearance

Natural Cycles, birth control

Credit: Natural Cycles 

By Sara Mageit 07:20 am October 20, 2020
Swedish CE-certified birth control app, Natural Cycles has announced that it has submitted a 510(k) Premarket Notification to the U.S. Food and Drug Administration (FDA). The Natural Cycles app, is the first and only FDA cleared birth control app in the US.  WHY IT MATTERS The purpose of the notification is to revise the labeling to expand the third-party thermometers, which include wearables...
By Dave Muoio 03:03 pm August 18, 2020
23andMe announced this morning that it has received a 510(k) clearance from the FDA that allows its direct-to-consumer personal pharmacogenetics report to guide use of two treatments without the need for confirmatory testing. WHAT HAPPENED This action updates a De Novo approval granted to the consumer genomics company in late 2018. That decision allowed 23andMe to market a test for one of 33...
By Dave Muoio 02:56 pm July 24, 2020
Abbott has received FDA approval for a neuromodulation system-controller app that runs on iOS devices, the company announced Thursday. Compatible with Abbott's broader NeuroSphere Digital Care platform, the Patient Controller app replaces the separate device patients use to adjust the company's neuromodulation products. These include the Infinity DBS System for Parkinson's disease or essential...
By Mallory Hackett 03:22 pm July 16, 2020
Today the remote and continuous-monitoring platform Vitls announced that it has received 510(k) clearance from the FDA. The Vitls Platform uses a single wearable device called Tégo that records vital signs. The device itself is wireless and waterproof, and it has a battery life up to 6 days. It records body temperature, pulse, heart rate variability, respiration rate, oxygen saturation, sleep and...
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...