Tandem Recalls Mobi Insulin Pumps over Software Malfunction
Tandem Diabetes Care issued a Class I recall for its Mobi insulin pump after a software defect was found to falsely detect motor failure, stopping insulin delivery and cutting communication with continuous glucose monitors and the mobile app. The FDA’s enforcement report lists more than 17,700 affected units and four serious injuries tied to the malfunction. Patients have been instructed to install the latest software update immediately and keep a backup insulin delivery method ready. The action follows a series of FDA safety interventions targeting diabetes‑device manufacturers this year.
CDRH Director Tarver Previews AI Guidance at AAMI Event
At the AAMI neXus conference, FDA CDRH Director Michelle Tarver announced that final guidance on AI lifecycle management will be issued later this year, building on the draft released in January 2025. The guidance will codify requirements for representative training...
Boston Scientific Slashes 2026 Guidance
Boston Scientific reported first‑quarter revenue of $5.2 billion, up 11.6% year‑over‑year, and net income of $1.34 billion, double the prior year. The company trimmed its 2026 sales growth outlook to 7%‑8.5% and adjusted EPS guidance to $3.34‑$3.41, down from the February ranges....
Intuitive Surgical Lifts 2026 Outlook for Da Vinci Robot Procedure Growth
Intuitive Surgical reported a strong first quarter, posting $2.77 billion in revenue, a 23% year‑over‑year increase, and $822 million net income. Da Vinci robot placements rose to 431, driving a 16% rise in procedures and prompting the company to lift its 2026 outlook...
MiniMed Posts Double-Digit Sales Growth, Widening Net Loss
MiniMed, Medtronic’s diabetes‑tech spinoff, posted FY26 Q3 revenue of $790 million, up 15 % year‑over‑year, but its net loss widened dramatically to $119 million from $10 million a year earlier. Growth was driven by sales of its automated insulin‑delivery system, FDA clearance for the...
Medtronic Closes $585M Purchase of CathWorks
Medtronic announced the closing of its $585 million acquisition of CathWorks, bringing the AI‑driven FFRangio system into its cardiovascular portfolio. The purchase follows a February agreement and includes potential earn‑out payments. It is part of an accelerated M&A strategy that also...
RFK Jr. Defends HHS Tenure, 12% Proposed Budget Cut
Health and Human Services Secretary Robert F. Kennedy Jr. defended his tenure and the Trump administration’s FY2027 budget proposal that would slash HHS discretionary spending by 12.5%, roughly $16 billion. The plan includes a $5 billion cut to NIH and a $4 billion...
LTS Lohmann Builds a Foundation for Proactive Quality and Innovation
LTS Lohmann Therapy Systems is overhauling its quality management by deploying a unified, enterprise‑wide QMS and advanced data analytics. The new platform eliminates manual bottlenecks and data fragmentation, delivering real‑time traceability and AI‑ready insights across all sites. By partnering with...
From Imaging to Understanding, How Real-Time 3D Is Evolving the Clinic of the Future
Barco and Avatar Medical unveiled Eonis Vision, a glasses‑free, real‑time 3D imaging system that turns CT and MRI scans into lifelike, floating models during patient consultations. The solution runs on Dell Pro Precision workstations powered by NVIDIA RTX PRO GPUs, delivering...
Siemens Plans Shareholder Vote on Siemens Healthineers Spinoff
Siemens announced it will ask shareholders to vote on a plan to spin off Siemens Healthineers at the February annual meeting. The proposal would transfer 30% of Healthineers shares to Siemens investors, reducing the parent’s stake from 67% to roughly...
GE HealthCare, RadNet Expand AI Mammography Collaboration
GE HealthCare is widening its AI mammography partnership with RadNet subsidiary DeepHealth, adding more artificial‑intelligence tools to its Pristina Via system. The expanded pact introduces features such as cancer detection, automated density assessment, and lesion localization, plus an optional secondary‑review...
Abbott Lowers Earnings Forecast After $21B Exact Sciences Buy
Abbott lowered its 2026 adjusted EPS forecast to $5.38‑$5.58 after completing a $21 billion acquisition of Exact Sciences. The deal adds Exact’s Cologuard colorectal‑cancer screening test, which Abbott expects to generate about $3 billion in incremental sales this year. Q1 revenue rose...
Boston Scientific Plans $88.5M R&D Expansion in Ireland
Boston Scientific announced a €75 million (≈ $88.5 million) investment to expand its Galway, Ireland R&D campus, concentrating on cardiovascular innovation. The upgrade will add advanced laboratories for structural‑heart, heart‑failure and renal‑denervation programs. The Irish government, via IDA Ireland, will provide financial support...
Medtronic Confirms Paclitaxel Balloon’s Efficacy in Post-Approval Trial
Medtronic reported that its IN.PACT AV paclitaxel‑coated balloon achieved a 70.2% target lesion patency rate at 12 months in a post‑approval study of end‑stage kidney disease patients. This figure mirrors the 65.3% rate observed in the pivotal trial that secured FDA...
Stereotaxis to Buy Robocath for up to $45M
Stereotaxis announced it will acquire French robotic‑surgery firm Robocath for up to $45 million, paying $20 million upfront and up to $25 million contingent on milestones such as FDA clearance of Robocath’s next‑generation system. The deal merges Stereotaxis’s magnetic navigation platform with Robocath’s...