Company Product Description Indication Status
Ava Science Inc., of San Francisco Ava Fertility Tracker Sensor bracelet wearable and accompanying app that uses machine learning Measures and displays physiological parameters as an aid in ovulation prediction to facilitate conception Received 510(k) clearance from the U.S. FDA
Bactiguard Holding AB, of Tullinge, Sweden BIP Foley Tempsensor catheter Urinary catheter with integrated temperature sensor and microbe resistant coating For infection prevention in hospitalized patients Received COVID-19 interim order approval from Health Canada
Nyxoah SA, of Mont-Saint-Guibert, Belgium Genio Battery-free, leadless and minimally invasive implanted neurostimulator Treats obstructive sleep apnea Received U.S. FDA approval for full-body 1.5T and 3T MRI compatibility
Soundbite Medical Solutions Inc., of Montreal, Quebec Soundbite Crossing System – Peripheral (14P) Shockwave-based technology platform; includes the Soundbite Console and the 0.014" Soundbite Active Wire Treats peripheral artery disease patients with heavily calcified above-the-knee and below-the-knee chronic total occlusions Received Health Canada approval; previously received approval for 0.018" platform

Notes

For more information about individual companies and/or products, see Cortellis.