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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K254090

510(k) cleared

I-View®

Hologic, Inc. · Sep 2, 2026 · K254090

FDA cleared the I-View® from Hologic, Inc. on Sep 2, 2026 under K254090, a traditional 510(k). The device falls under product code MUE, Full Field Digital, System, X-Ray, Mammographic, regulated at 21 CFR 892.1715 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 19, 2025. The decision came 257 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hologic, Inc. has 4 other decisions in the tracker over the last 12 months: K262792 (Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)), K253634 (CoolSeal Generator® (CSL-200-90)), K251868 (Panther Fusion GI Bacterial Assay), K251993 (Panther Fusion GI Expanded Bacterial Assay).

Questions & Answers

What did FDA clear under K254090?

K254090 is the FDA 510(k) for I-View®, submitted by Hologic, Inc.. FDA's decision date was Sep 2, 2026, under product code MUE (Full Field Digital, System, X-Ray, Mammographic).

Who makes the I-View®?

Hologic, Inc., based in Newark, DE, is the applicant of record for K254090.

How long did the K254090 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Sep 2, 2026, 257 days later.

← All decisions in September 2026

Sources