Dexcom announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription. This marks the first FDA clearance for a continuous glucose monitoring (CGM) technology for over-the-counter use. In January, Dexcom first announced that it submitted the new Stelo sensor to the FDA for review at the end of last […]
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Baxter is closing Massachusetts facility
Baxter will shutter its manufacturing facility in Acton, Massachusetts. In a statement shared with MassDevice, the company said: “We made the difficult decision to close manufacturing operations at our Acton location. We are moving these operations to another facility within Baxter’s integrated supply chain network. We appreciate our Acton-based colleagues’ dedication and service and are […]
Medtronic may face jury trial in spine implants case
A nearly decade-old whistleblower suit against Medtronic — involving FDA clearance of spine fusion devices — is moving forward. In an order dated Feb. 16, U.S. District Court Judge John Kronstadt in Central California denied Medtronic’s motion for summary judgment in the case filed by The Dan Abrams Co. LLC. The LLC’s sole employee, Bryan […]
Stereotaxis submits Magic ablation catheter for U.S., European approval
Stereotaxis (NYSE:STXS) announced that it submitted its Magic ablation catheter for both European and U.S. regulatory approval. The company said its FDA and CE mark submissions follow successful clinical results in an ongoing trial. Last month, Stereotaxis announced the first Magic treatments in the European trial supporting its submissions. According to a news release, the […]
Haemonetics agrees to acquire esophagus-protecting device maker Attune Medical
Haemonetics announced today that it entered into an agreement to acquire Attune Medical. Boston-based Haemonetics agreed to buy Attune for an upfront cash payment of $160 million. The deal also includes additional contingent consideration based on sales growth in the three years following the consummation of the acquisition. These additional payments also hinge on other […]
Fast Five: Baxter considers Kidney Care sale instead of spin, Medtronic earns FDA nod for bone ablation tech
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, March 5, 2024. Fast Five by MassDevice · Fast Five: Baxter considers Kidney Care sale, Medtronic earns FDA nod for ablation tech The FDA approved […]
GE Healthcare’s AI models can predict patient responses to immunotherapy
GE HealthCare today announced data showing its AI models’ ability to accurately predict patient responses to immunotherapies. The study collected clinical data to accurately forecast the effectiveness and toxicity of cancer immunotherapy. Data demonstrated accuracy between 70% and 80% with the AI models in a pan-cancer cohort. Investigators published outcomes in the Journal of Clinical […]
Baxter in talks over Kidney Care sale, expects separation later this year
Baxter today shared an update on the planned separation of its Kidney Care business as it looks at a potential sale instead of a spinoff. In January 2023, Baxter announced plans to spin its renal care and acute therapies units into an independent, publicly traded company. It said at the time that it expected the […]
Medtronic wins FDA clearance for bone tumor ablation tech
Medtronic announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system. The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to […]
FDA approves Boston Scientific’s Agent drug-coated balloon
Boston Scientific announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Marlborough, Massachusetts–based Boston Scientific plans a U.S. launch for Agent in […]
FDA reportedly finds animal lab issues at Neuralink facility
Reuters reports that FDA inspectors identified issues with record keeping and quality controls for animal experience at Neuralink. This isn’t the first time questions have been raised over the Elon Musk-backed brain-computer interface company’s animal practices. Over the past couple of years, the company has drawn concerns over animal welfare and hazardous material transport practices. Reuters‘ report […]