Latest from Marion Webb
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.
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.
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.
Volta Files For US FDA Approval Of Next-Gen Cardio Mapping Software After Winning Labeling Expansion
Volta Medical received a labeling expansion for its AF-Xplorer mapping software to treat A-fib, which provides the clinical evidence needed to broaden US access. The company hopes for FDA clearance for its improved second-gen AF-Xplorer II software.
Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.
SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.