Diagnostic Imaging

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

The US FDA has published final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

Zydus bags two generic gadolinium-based contrasting agents in an exclusive licensing and supply agreement with Viwit, opening a new chapter of imaging injectables for the US market.

The US FDA now requires mammograms include information about breast density, a significant factor that raises breast cancer risk and can hide tumors.

Cardio-oncology and cardiotoxicity have come directly into the spotlight following ESC's first consensus guidelines. AI is being used for early risk identification, Philips said during the European Society of Cardiology congress 2024.

Sonio says its acquisition by global medical equipment company Samsung Medison is a wrap. Plans for the deal were announced earlier this year.

This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.

Medtronic receives US FDA approval for deep brain stimulation surgery for people with Parkinson’s and essential tremors while the patient is under general anesthesia, making it the first and only company to offer DBS surgery while the patient is asleep.

The global leaders in imaging have set full-year sales growth outlooks of low to mid-single digits, with China market headwinds due to prevail throughout 2024. Pent-up China demand will be the upside from 2025, industry believes.