510(k)

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The FDA released two final guidances and a new draft guidance today to increase the regulatory clarity around medical devices, including software as a medical device.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...