510(k)

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...

Credit: NuvoAir

By Sara Mageit 04:41 am August 18, 2020
Sweden-based digital therapeutics respiratory company, NuvoAir, has been certified as a Class Im medical device. The NuvoAir Home platform includes Air Next, a certified bluetooth spirometer, a connected patient app and a healthcare portal.   WHY IT MATTERS Patients can use the platform to self-monitor their respiratory health and share clinically relevant data with their care teams, who can view...
By Dave Muoio 03:19 pm May 26, 2020
Digital respiratory health company Propeller Health has received 510(k) clearance for a sensor and app intended for use with AstraZeneca's Symbicort inhaler for asthma and COPD, the company announced today. The tool – which, according to the agency, was submitted to the agency in September and greenlit in late March – was developed in a previously unannounced partnership with the Cambridge,...
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 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 11:13 am January 22, 2020
Editor's note: This story has been updated with information from Verily's announcement of the clearance.  Verily, the life sciences research subsidiary of Alphabet, has received FDA 510(k) clearance for an augmented version of its prescription Study Watch wearable that includes some form of arrhythmia monitoring. The Study Watch With Irregular Pulse Monitor is classified by the FDA as a “...
By Dave Muoio 03:18 pm January 9, 2020
Respiratory monitor maker NuvoAir (formerly Pond Healthcare Innovation) has picked up its first FDA 510(k) for Air Next, a portable and connected home-use spirometer device. According to the FDA’s premarket notification database, the Stockholm, Sweden-based company submitted its application in November 2018, and received the decision last Thursday. The Air Next is designed for patients with...
By Dave Muoio 03:56 pm December 5, 2019
#Pelotonad. Peloton has found itself in the middle of controversy as a recent television ad released by the company was panned by many as sexist. The roughly 30-second video, in which a husband purchases the connected exercise bike for his wife as a Christmas gift, has generated a backlash consisting of Twitter hashtags, viral parodies and a roughly 10% drop in Peloton’s stock price; however, the...
By Jonah Comstock 03:37 pm October 24, 2017
The FDA released two final guidances and a new draft guidance today to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the first qualified tool under the voluntary Medical Device Development Tools (MDDT) program. "Medical device technology evolves quickly. The process for improving the performance and clinical...