To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.
Corify Care’s CEO said the company aims to submit its 510(k) application to the US FDA by year-end, targeting market clearance in 2026. The company hopes its collaboration with the Mayo Clinic will help speed adoption of ACORYS, a noninvasive mapping technology for use in complex cardiac ablations.
“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.
The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.
Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.
Backed by £50m of UK government funding, the new research center will delve into neural dynamics to develop novel devices ranging from brain implants to wearables.
Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.
Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.
Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.
