Medicare announced coverage for the Dexcom G7 continuous glucose monitor, as well as a breast cancer indication for Natera Inc.’s Signatera; the FDA authorized a new monkeypox test; the FDA issued a warning letter to a Texas masks firm; and a new report says NIST labs are failing behind.
The Jonas Brothers aren’t the only ones getting access to the DexCom, Inc. G7 continuous glucose monitor; Dexcom announced that these devices will also be covered by Medicare. (Also see "Dexcom Doubles Down On Jonas Branding To Hail G7 Launch" - Medtech Insight, 10 February, 2023.)
The Dexcom G7 meets the requirements for CGMs systems outlined by the Center for Medicare and Medicaid and will be available to Medicare patients with Type 1 and Type 2...
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
