Medical Device Weekly Perspective

Research evidence excerpt

Medical Device Weekly Perspective

Dexcom's G7

platform, pairs a wearable sensor with a smartphone app to provide glucose readings and trends every

15 minutes. Each sensor lasts up to 15 days, though wear time may be shorter in children. The clearance

expands Stelo's original March 2024 authorization for adults 18+. The FDA relied on real-world evidence

alongside prior clinical study data to assess pediatric performance. No other OTC CGM is available for

children. See FDA announcement here.

JNJ: Johnson & Johnson Invests More Than $1 Billion to Strengthen U.S. Vision Manufacturing in

Jacksonville, Florida (6/15). J&J announced an investment of more than $1 billion in Jacksonville, Florida

to scale its U.S.-based Vision manufacturing, packaging, and distribution capabilities for its ACUVUE

brand contact lenses. The Jacksonville facility employs ~3,500 people and produces approximately 1.7

billion contact lenses annually (~90% of ACUVUE U.S. sales). The new facilities are expected to be fully

operational by 2028. The investment is part of J&J's $55 billion domestic investment package committed

in 2025. A new apprenticeship program is also being created at the site. See full press release here.

Penumbra Expands CAVT for Stroke to Europe with CE Mark for THUNDERBOLT (6/15). PEN announced

it has secured CE Mark in Europe for THUNDERBOLT, further laying the groundwork for launching

computer assisted vacuum thrombectomy (CAVT) technology to address acute ischemic stroke globally.

The company received U.S. FDA clearance the prior week. The THUNDERBOLT CAVT technology

introduces modulated aspiration for acute ischemic stroke for the first time, enabling more rapid,

complete clot removal.

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