Hologic plans to close certain international facilities amid product discontinuations and restructuring within its diagnostics business. The company outlined the changes — first reported by MedTech Dive — in its quarterly Form 10-Q filed with the SEC, dated Feb. 2, 2024. Hologic reported accelerated depreciation of $7.2 million and a lease asset impairment charge totaling […]
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JenaValve publishes positive data for its TAVR system
JenaValve announced today that it published new results supporting the use of its transcatheter aortic valve replacement (TAVR) system. The company published results from its ALIGN-AR pivotal trial in The Lancet. The trial evaluates the Trilogy valve in high-risk patients with symptomatic moderate-to-severe or severe aortic regurgitation. JenaValve presented positive study results from ALIGN-AR last […]
RefleXion inks AI partnership for cancer treatment planning
RefleXion Medical announced today that it signed a licensing agreement with Limbus AI to incorporate software into radiation treatment planning. The agreement enables the integration of the Limbus Contour automated contour software into the RefleXion X1 system. X1 uses biology-guided radiotherapy (BgRT) technology. It enables a PET radiotracer to create a unified motion management solution […]
FDA clears sleep monitoring software from Beacon Biosignals
Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring. SleepStageML automatically stages sleep from electroencephalogram (EEG) signals of clinical polysomnography (PSG) recordings. It aids in the diagnosis and evaluation of sleep and sleep-related disorders. Boston-based Beacon Biosignals said in a news release that the software could enable […]
Tandem Diabetes Care taps miniaturization and automation for its latest systems
Tandem Diabetes Care (Nasdaq:TNDM) EVP and Chief Strategy Officer Elizabeth Gasser didn’t exactly plan for the whirlwind past year or so. In the space of about two months, Tandem announced continuous glucose monitor (CGM) integration with the latest-generation technology from Dexcom and Abbott, launched its Tandem Source diabetes management platform and began the rollout of […]
Ypsomed sells pen needle, blood glucose monitor business to focus on insulin pump
Ypsomed announced today that it agreed to sell its pen needle and blood glucose monitoring (BGM) businesses to Medical Technology and Devices (MTD). With the transfer of these businesses, Ypsomed plans to focus its diabetes care business on insulin pumps. Specifically, it looks to the further development and marketing of the mylife Loop automated insulin […]
GE HealthCare unveils AI-enabled urology software
GE HealthCare announced today that it launched its Prostate Volume Assist (PVA) urology-based AI software feature. The company designed the software feature to support clinicians in prostate imaging, biopsies and guiding treatment. It assists urologists by improving workflows and quickly capturing prostate volume. The added functionality with PVA helps determine calculations and measurements of the […]
Neuralink may be getting some scrutiny on Capitol Hill
Reuters reports that U.S. Rep. Earl Blumenauer (D-OR) issued a letter to the FDA questioning its inspection practices related to Neuralink. The report said Blumenauer asked why the FDA decided not to investigate the Elon Musk-backed brain chip maker before allowing in-human trials. This relates to repeated questions around animal practices at the company. Reuters […]
Synaptive Medical wins FDA nod for near-infrared fluorescence in robotic exoscope
Synaptive Medical announced today that it received FDA 510(k) clearance for its near-infrared fluoresence visualization module on its robotic exoscope. The Toronto-based company can now add its Modus IR module to the existing fluorescence offering on the 4K, 3D Modus X system. Modus IR bolsters the capabilities of the exoscope across all neurosurgical procedures, as […]
SyntheticMR wins FDA clearance for 3D brain scanner
SyntheticMR announced today that its next-generation 3D imaging solution with isotropic resolution received FDA 510(k) clearance. Linköping, Sweden-based SyntheticMR said in a news release that the regulatory nod “marks a significant advancement in quantitative MRI technology.” The company says its SyMRI 3D offering provides “unprecedented resolution and accuracy in brain imaging.” Approval marks the second […]
FDA wants to ban electrical stimulation devices for self-injurious, aggressive behavior
In a rare move, the FDA is taking steps to ban electrical stimulation devices (ESDs) for self-injurious or aggressive behaviors. Owen Faris, acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health, announced the proposal this week, marking the second attempt by the agency to […]