Diagnostic Imaging

Philips, the last of the global top-three imaging companies to report 2024 financial results, said the soft China market put the brakes on its growth. The regional outlook for early 2025 is no different, and US-China tariffs will present another challenge.

The US market’s largest imaging manufacturer marked two years as an independent company with plans to invest in more M&A and PDx production capacity, but reported a modest 2025 revenues outlook.

Any tariff headwinds should be counterbalanced by currency tailwinds, predicts German imaging and diagnostics company Siemens Healthineers.

Medtech Insight was on the ground at HLTH looking for innovative companies. Learn about seven start-ups using AI to help physicians detect conditions including prostate and breast cancers, seizures and heart failure; assess patients for cognitive decline validate and deploy algorithms, and monitor patients in and out of the hospital.

Medtech Insight spoke with Vicky Demas, CEO of Identifeye, about plans for bringing the company’s AI-powered retinal screening system for early detection of diabetic retinopathy to primary care facilities. More than 50% of the roughly 38 million Americans who have diabetes skip retinal screenings at present, increasing risk of developing the leading cause of blindness in adults.

Start-ups pitched a diverse deck of innovative technologies to three judges and an audience of potential investors, strategics and physicians at the Octane Medical Innovation Forum in Irvine, CA. Highlights include neuromodulation company Sinaptica Therapeutics, which won the competition for both “People’s Choice” and “Judge’s Choice.”

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.