In this worrying COVID-19 environment that has been unleashed in the world, it is refreshing to hear some good news about medical device breakthroughs.
In mid-September 2020 Avinger announced it received FDA clearance for its Ocetaris image-guided chronic total occlusion (OTC) crossing system. Marketed under the brand name TigerEye, this medical device breakthrough will provide real-time imaging from inside the vessel during CTO-crossing procedures. It also allows physicians to accurately navigate and treat peripheral artery disease lesions without exposing healthcare workers and patients to the negative effects of ionizing radiation. National launch is expected in early 2021.
Stroke Patient Device Adapted for COVID-19
So new it doesn’t have a catchy marketing name yet, a medical device breakthrough designed to detect speech and swallowing problems in stroke patients has found a new use in tracking cough frequency in frontline workers to alert healthcare providers to test for COVID-19. The postage-stamp-size wearable adheres to the skin at the base of the neck and generates data for up to 40 hours straight without needing a recharge.
Kaiser Health News reported 922 U.S. healthcare worker deaths that likely stemmed from caring for COVID-19 patients. “We anticipate that the advanced algorithms we are developing will extract COVID-like signs and symptoms from the raw data insights even before individuals may perceive them,” said Arun Jayaraman, a research scientist at Shirley Ryan AbilityLab who is working with the device.
The researchers have $1.5 million in federal funding from BARDA (Biomedical Advanced Research and Development Authority Federal Agency) for device development. They have applied for FDA clearance rather than emergency use authorization due to EUA only lasting for the duration of the public health emergency. They are producing 100 devices per week but have a company in place, Sonica Health, that will take over production once the FDA clears the device. The initial target market is to frontline workers, patients, military and elderly populations.
Interested in being part of medical device breakthroughs? Contact Smith Hanley Associates’ Executive Recruiter in Medical Devices, Gary Cavanagh at [email protected].