FDA clearance
AI company physIQ landed FDA clearence for its atrial fibrillation detection analytics software.
Masimo's acoustic respiration sensor, the RAS-45 for Rainbow Acoustic Monitoring, is clearedfor use among infants and neotal patients 10kg and under.
The FDA announced today that it will allow marketing of Natural Cycles’ contraception app in the US for pre-menopausal women aged 18 years and older.
Connected inhaler sensor maker Adherium has received 510(k) clearance for US over-the-counter sales of its Hailie sensor, formerly known as Smartinhaler.
Zebra Medical Vision receives its first 510(k) clearance for coronary artery calcification algorithm
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced that it has received FDA 510(k) clearance for an algorithm that helps physicians quantify a patient’s coronary artery calcification.
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.
Children with Type 1 diabetes will now have access to the Medtronic MiniMed 670G, a hybrid closed-loop system insulin delivery system, following the FDA’s decision to expand the product approval for a younger demographic.
Cerebrovasular imaging company iSchemaView has received the FDA nod for its latest product the RAPID CTA, a 3D imaging platform for computed tomogrpahy angiography (CTA).
Correction: A previous version of this story misstated that PhysioWave connects to the user's smartphone.
China-based Viatom Technologies has received FDA 510(k) clearance for Checkme Pro, a connected medical device that tracks a number of vital signs, according to Medgadget.