Shubham Singh has been a journalist since 2018, covering business and consumer technology for leading media organizations such as India Today, CNBC-TV18, Zee News, and others. As a Reporter for Medtech Insight, he covers policy, regulation, and digital tech. Outside work, Shubham is an avid traveler, foodie, and fitness enthusiast, balancing his schedule with gym sessions, trekking, and OTT binge-watching.
Latest from Shubham Singh
CMS is proposing to classify all CGMs and insulin pumps as “items requiring frequent and substantial servicing” to expand device choice and access for Medicare beneficiaries. Under this framework, CMS also intends to move Class II devices, which include CGMs from Abbott and Dexcom and pumps from Tan
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.
While European sustainability directives CSDDD and CSRD are still in the process of adoption, environmental group Swedwatch claims the EU's procurement framework is devoid of accountability.
EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.
Openwater is currently focusing on EMS applications of its AI-powered stroke detection technology, both in-hospital and prehospital, such as in ambulances and urgent care centers.
Remepy is exploring two potential regulatory pathways to support this strategy. The first is a combination product pathway that would formally integrate software and drug into a single therapeutic entity. The second is the FDA’s Prescription Drug Use-Related Software (PDURS) pathway.