US Medicare has issued a final rule broadening coverage of continuous glucose monitors, including those integrated with Medtronic insulin pumps. The rule classifies adjunctive monitors, which treat diabetes, as durable medical equipment under the Medicare Part B benefit.
The US Centers for Medicare & Medicaid Services (CMS) has issued a final rule that increases treatment options for diabetes patients with government plans.
The Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) rule expands Medicare coverage of continuous glucose monitors (CGMs) by classifying...
The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.
Medtronic and Abbott announced partnership to integrate Abbott’s CGM sensor with Medtronic’s insulin pump, which marks a major departure from Medtronic’s former “closed-system” approach. Medtronic also announced FDA clearance of its Simplera CGM, paving the way for its use in smartpens.
Philips has filed a lawsuit against a Pennsylvania lab it hired to analyze sound abatement foam that prompted widespread recalls of its CPAP machines. Philips alleges PSN Labs grossly overestimated the risk to patients, which led Philips to initiate a larger recall than it otherwise would have.
While the National Electrical Manufacturers Association supports the Biden Administration’s plan to impose tariffs on a range of Chinese goods coming into the US, it also supports holding off on their implantation.
Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.
An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.
TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.
