Diagnostics
GE HealthCare secures CE mark for photon-counting CT device
GE HealthCare announced on Monday that its spectral photon-counting CT device, Photonova Spectra, has received the CE mark, marking a key milestone in European market access for the technology. The device had previously been approved in the United States and Japan. The CE mark will support the company in launching commercialization in markets such as the European Union, Switzerland, and the United Kingdom, and may streamline the approval process in countries like Australia and Singapore. Photonova will directly compete with Siemens Healthineers' Naeotom Alpha series, which was first approved in Europe in 2021.
Cleveland Diagnostics hires new CFO
Cleveland Diagnostics announced on Tuesday that it has hired Valerie Dixon as Chief Financial Officer, aiming to establish a financial foundation for the large-scale commercialization of its IsoPSA prostate cancer test. Dixon previously served as a Senior Partner in Financing Services at Flagship Pioneering.
Guardant Health ordered to pay $245M in patent dispute
The U.S. District Court for the District of Delaware issued a final judgment against Guardant Health, requiring it to pay over $245.2 million to TwinStrand Biosciences and the University of Washington for patent infringement related to DNA sequencing technology. The judgment includes $83.4 million in jury-awarded damages, supplemental damages, accrued royalties, and interest, and mandates that Guardant pay a 6% ongoing royalty on 11 products until the patents expire in 2033. Guardant expressed strong disagreement and will appeal.
How Guardant aims to expand cancer screening with a blood test
Guardant Health's Shield blood test, approved by the FDA in 2024 for colorectal cancer screening, is gaining clinical traction with UnitedHealthcare coverage and an American Cancer Society endorsement. The company is now pursuing next-generation improvements to boost sensitivity for early-stage cancers and precancerous lesions, while expanding Shield into multicancer detection following a breakthrough device designation. In an interview with MedTech Dive, Guardant's VP of clinical development Sam Asgarian discusses real-world adoption, performance limitations, and the path to FDA approval for a multicancer version.
J&J’s Monarch robot wins FDA nod for AI features
Johnson & Johnson announced on Monday that its Monarch bronchoscopy robot received FDA approval for the Quest 3 software update, adding features such as AI-assisted planning, 3D visualization, and expanding compatibility with common imaging systems. This is the fourth major software release for the Monarch system in 18 months.
FDA Schedules Advisory Committee Meeting for Galleri Multi-Cancer Early Detection Test
The FDA has scheduled an advisory committee meeting for September 2026 to review Grail's premarket approval application for the Galleri multi-cancer early detection blood test. Galleri was launched as a laboratory-developed test in 2021 and submitted for FDA approval this year, but a key trial did not meet its primary endpoint. Grail CEO Josh Ofman stated that the company still expects Galleri to receive FDA approval in the first half of 2027.
Danaher appoints Julie Sawyer Montgomery as next CEO
Danaher announced on Monday that Julie Sawyer Montgomery will succeed Rainer Blair as President and CEO, effective October 1. Blair is retiring after six years as CEO and will serve as a senior advisor until March 31, 2027. Montgomery previously served as Executive Vice President, overseeing the diagnostics business, during which time revenue grew from approximately $6 billion to about $11 billion, with operating profit roughly tripling. She led the $9.9 billion acquisition of Masimo and the pending acquisition of StatLab. Analysts believe this appointment is not a strategic shift toward diagnostics but rather a recognition that her platform operating capabilities can be replicated across other areas.
Siemens Healthineers Appoints New President and Head of Americas Region
Siemens Healthineers has announced João Seabra as the new President and Head of the Americas region, effective October 1. Seabra joined the company in 2001 and has led the Enterprise Services business since 2018, achieving a fourfold revenue increase. His predecessor, John Kowal, departed after only a few months in the role, and the company's leadership has undergone several changes since May.