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 “...
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...
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...
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