GE HealthCare announced today that it agreed to acquire AI and medical imaging analysis provider MIM Software. GE HealthCare plans to fund the acquisition — for which financial terms were not disclosed — with cash on hand. MIM Software provides AI-based software for radiation oncology, molecular radiotherapy, diagnostic imaging and urology. The Cleveland-based company’s offerings […]
Digital Health
FDA clears next-gen handheld ultrasound from Butterfly Network
Butterfly Network (NYSE:BFLY) announced today that it received FDA clearance for its next-generation handheld ultrasound system. BFLY shares were up more than 23% to $1.25 apiece on the news. MassDevice‘s MedTech 100 Index was up more than 1%. The Butterfly iQ3 point-of-care ultrasound (POCUS) system marks the third iteration of the company’s technology. Burlington, Massachusetts- […]
SimBioSys wins FDA nod for TumorSight precision medicine platform
SimBioSys announced that it received FDA 510(k) clearance for its TumorSight cloud-based digital precision medicine platform. FDA clearance came just days after the company inked a partnership with Mayo Clinic to develop precision medicine solutions. The TumorSight platform takes a patient’s standard-of-care imaging to build a custom 3D model of their tumor. The tool provides […]
Better Therapeutics, Glooko partner on digital diabetes management
Better Therapeutics and Glooko today announced a partnership to integrate technologies and enhance diabetes management. The partnership aims to integrate Better Therapeutics’ ApsyreRx digital behavioral treatment into Glooko’s diabetes management platform. Better Therapeutics designed AspyreRx to treat type 2 diabetes. The FDA authorized AspyreRx as a prescription digital therapeutic for diabetes in July. Palo Alto, […]
Nanowear wins FDA nod for AI-enabled wearable blood pressure monitor
Nanowear announced today that its SimpleSense nanotechnology-enabled wearable and software platform received FDA 510(k) clearance. The AI-enabled noninvasive, cuffless, continuous blood pressure monitor and diagnostic offers a tool in the diagnostic management of hypertension. It adds to the wearable platform’s previously cleared cardiopulmonary diagnostics. The FDA cleared it as software as a medical device (SaMD). […]
Align Technology acquires 3D printing company Cubicure
Align Technology (Nasdaq:ALGN) announced that it completed the acquisition of 3D printing company Cubicure. Cubicure offers 3D printing solutions for polymer additive manufacturing. It develops, produces and distributes innovative materials, equipment and processes for novel 3D printing solutions. Tempe, Arizona-based Align plans for the acquisition to support and scale its strategic innovation roadmap and strengthen […]
CMR Surgical reports record surgical robot installations to end 2023, plans 2024 product launches
CMR Surgical announced today that it closed 2023 with a record number of Versius surgical robot installations in one quarter. The company also plans to launch new advanced technologies to further support the utilization of Versius in 2024. These technologies include enhancements in vision, instrumentation and digital. Cambridge, UK-based CMR Surgical said in a news […]
HeartFlow hits 250,000-patient mark
HeartFlow announced today that it surpassed 250,000 patients receiving its FFRCT Analysis for non-invasively diagnosing coronary artery disease. FFRCT Analysis and coronary computed tomography angiography (CCTA), provide an alternative to traditional ischemia testing methods. These methods include stress EKG, stress ECG, SPECT, PET and more. According to HeartFlow, these methods can result in false negatives […]
SimBioSys, Mayo Clinic partner on AI-powered tech for breast cancer patients
SimBioSys announced today that it entered into a strategic collaboration with Mayo Clinic to develop digital precision medicine solutions. The collaboration aims to develop cloud-based clinical software to support end-to-end decision-making for early-stage breast cancer patients. This includes individualized surgical planning, treatment, drug selection and risk stratification. As part of the collaboration, SimBioSys has had […]
Apple Watch ban goes into effect after Masimo patent battle, presidential review
President Joe Biden’s administration declined to veto an import ban on Apple Watches after the government ruled in favor of Masimo in a patent spat. The long-running battle between companies came to a head last week when Apple paused sales of two models of its smartwatch. This spat centers around light-based pulse oximetry technology used […]
Medtronic has a Class I recall for its surgical navigation software
The FDA deemed the recall of Medtronic StealthStation S8 software Class I, the most serious kind. This recall — a correction, not a product removal — relates to StealthStation S8 Application Version 2.0 and 2.0.1. It affects 2,109 devices distributed in the U.S. between Jan. 7, 2022, and Oct. 2, 2023. Medtronic initiated the recall […]