https://healthsensemag.com/News and analysis on medical technologyen-us https://healthsensemag.com/explainers/cerevasc-alzheimers-study-shows-how-investigational-device-exemptionhttps://healthsensemag.com/explainers/cerevasc-alzheimers-study-shows-how-investigational-device-exemptionFri, 30 Oct 2026 12:00:00 -0800ExplainersAn IDE lets an unapproved device be used in a clinical study to gather safety and effectiveness data; it is not marketing authorization. https://healthsensemag.com/news/cooper-companies-ceo-albert-white-steps-down-rosebroughhttps://healthsensemag.com/news/cooper-companies-ceo-albert-white-steps-down-rosebroughThu, 29 Oct 2026 12:00:00 -0800NewsThe contact lens and fertility company began a CEO search and reshaped its board weeks after an activist investor pressed for leadership changes. https://healthsensemag.com/policy-regulation/fda-early-alert-covers-all-medline-beds-twohttps://healthsensemag.com/policy-regulation/fda-early-alert-covers-all-medline-beds-twoThu, 29 Oct 2026 12:00:00 -0800Policy & RegulationMedline reported two deaths and 16 serious injuries tied to fire and entrapment hazards, then revised its removal to allow continued use with new instructions. https://healthsensemag.com/devices/fda-expands-instyllas-embrace-hydrogel-embolic-approval-peripheralhttps://healthsensemag.com/devices/fda-expands-instyllas-embrace-hydrogel-embolic-approval-peripheralThu, 29 Oct 2026 12:00:00 -0800DevicesA panel-track PMA supplement adds bleeding in vessels up to 6 mm to the liquid embolic's original hypervascular tumor indication, based on the 130-patient HALT study. https://healthsensemag.com/news/heat-packs-heating-pads-make-up-83-fdahttps://healthsensemag.com/news/heat-packs-heating-pads-make-up-83-fdaThu, 29 Oct 2026 12:00:00 -0800NewsA study of a decade of MAUDE reports on electrophysical agents found one product line alone accounted for more than a third of the reports. https://healthsensemag.com/business/boston-scientific-cuts-2026-guidance-third-time-cyberattackhttps://healthsensemag.com/business/boston-scientific-cuts-2026-guidance-third-time-cyberattackWed, 28 Oct 2026 12:00:00 -0800BusinessThird-quarter sales grew 1.5% as the cyberattack and declines in Watchman and electrophysiology weighed on results, and the company now expects fourth-quarter sales to fall. https://healthsensemag.com/digital-health/fda-clears-deep-reasoning-ais-neurodr-software-neurovascularhttps://healthsensemag.com/digital-health/fda-clears-deep-reasoning-ais-neurodr-software-neurovascularWed, 28 Oct 2026 12:00:00 -0800Digital HealthThe automated tool strips bone and veins from head and neck CTA scans and sends 3D artery views to hospital image archives. https://healthsensemag.com/policy-regulation/fda-drafts-guidance-requiring-estar-template-ide-applicationshttps://healthsensemag.com/policy-regulation/fda-drafts-guidance-requiring-estar-template-ide-applicationsWed, 28 Oct 2026 12:00:00 -0800Policy & RegulationOnce final, investigational device exemption applications would have to be filed electronically after a transition of at least one year, with no waivers planned. https://healthsensemag.com/digital-health/hhs-finalizes-hti-5-cutting-ehr-certification-criteriahttps://healthsensemag.com/digital-health/hhs-finalizes-hti-5-cutting-ehr-certification-criteriaWed, 28 Oct 2026 12:00:00 -0800Digital HealthThe final rule removes 14 of 60 criteria, fewer than proposed, keeps privacy and security requirements and defers information blocking changes. https://healthsensemag.com/treatments-trials/lillys-retatrutide-beats-semaglutide-a1c-weight-head-headhttps://healthsensemag.com/treatments-trials/lillys-retatrutide-beats-semaglutide-a1c-weight-head-headWed, 28 Oct 2026 12:00:00 -0800Treatments & TrialsCompany-reported TRANSCEND-T2D-2 results in 1,298 adults with type 2 diabetes also showed higher discontinuation rates for side effects on the investigational triple agonist. https://healthsensemag.com/devices/axora-medical-launches-herizon-rd5-5fr-battery-poweredhttps://healthsensemag.com/devices/axora-medical-launches-herizon-rd5-5fr-battery-poweredTue, 27 Oct 2026 12:00:00 -0800DevicesThe single-use handheld resector, cleared by the FDA in August, fits 5Fr and larger hysteroscopes and is intended for use in the office or the operating room. https://healthsensemag.com/treatments-trials/pfizers-elrexfio-meets-phase-3-progression-free-survivalhttps://healthsensemag.com/treatments-trials/pfizers-elrexfio-meets-phase-3-progression-free-survivalTue, 27 Oct 2026 12:00:00 -0800Treatments & TrialsTopline MagnetisMM-32 results compared the BCMA bispecific antibody with three standard regimens in patients previously treated with anti-CD38 therapy and lenalidomide. https://healthsensemag.com/explainers/x9-designation-shows-what-fda-breakthrough-device-statushttps://healthsensemag.com/explainers/x9-designation-shows-what-fda-breakthrough-device-statusTue, 27 Oct 2026 12:00:00 -0800ExplainersThe designation brings closer contact with FDA reviewers and prioritized review, but no change in the evidence a device needs to reach the market. https://healthsensemag.com/business/radnet-agrees-acquire-teleradiology-provider-onrad-350-millionhttps://healthsensemag.com/business/radnet-agrees-acquire-teleradiology-provider-onrad-350-millionMon, 26 Oct 2026 12:00:00 -0800BusinessThe outpatient imaging operator would add hospital radiology staffing and remote reads as a third business segment, with an earnout worth up to $210 million. https://healthsensemag.com/digital-health/eko-health-launches-core-300-stethoscope-ai-murmurhttps://healthsensemag.com/digital-health/eko-health-launches-core-300-stethoscope-ai-murmurFri, 23 Oct 2026 12:00:00 -0800Digital HealthThe FDA-cleared device pairs acoustic and digital listening in one chestpiece and connects to Eko's murmur-detection software through a paid subscription. https://healthsensemag.com/devices/teleflex-freesolve-scaffold-gets-fda-breakthrough-device-designationhttps://healthsensemag.com/devices/teleflex-freesolve-scaffold-gets-fda-breakthrough-device-designationFri, 23 Oct 2026 12:00:00 -0800DevicesThe resorbable magnesium scaffold is not approved in the US; a 1,859-patient pivotal trial against the Xience drug-eluting stent is meant to support a future PMA application. https://healthsensemag.com/explainers/what-real-world-evidence-means-fda-device-decisionshttps://healthsensemag.com/explainers/what-real-world-evidence-means-fda-device-decisionsFri, 23 Oct 2026 12:00:00 -0800ExplainersData from health records, registries and claims can support device submissions under FDA guidance updated in December 2025, if the data are judged relevant and reliable. https://healthsensemag.com/devices/fda-clears-rivannas-boneenhance-machine-learning-module-accurohttps://healthsensemag.com/devices/fda-clears-rivannas-boneenhance-machine-learning-module-accuroThu, 22 Oct 2026 12:00:00 -0800DevicesThe 510(k) adds bone and soft-tissue labeling to a volumetric musculoskeletal ultrasound system; a fracture-detection module remains investigational. https://healthsensemag.com/business/abbott-plans-spin-off-8-5-billion-nutritionhttps://healthsensemag.com/business/abbott-plans-spin-off-8-5-billion-nutritionWed, 21 Oct 2026 12:00:00 -0800BusinessThe separation, targeted for the end of 2027, would leave Abbott with about $42 billion in annual sales from devices, diagnostics and established medicines. https://healthsensemag.com/news/fda-device-center-lost-22-staff-rehiring-directorhttps://healthsensemag.com/news/fda-device-center-lost-22-staff-rehiring-directorWed, 21 Oct 2026 12:00:00 -0800NewsCDRH director Michelle Tarver told The MedTech Conference the center has beaten its fiscal 2026 user-fee hiring target but is "not done" rebuilding. https://healthsensemag.com/policy-regulation/fda-finalizes-guidance-labeling-apps-used-prescription-drugshttps://healthsensemag.com/policy-regulation/fda-finalizes-guidance-labeling-apps-used-prescription-drugsWed, 21 Oct 2026 12:00:00 -0800Policy & RegulationThe agency treats app content as drug labeling and says device-connected apps generally belong in prescribing information, while most standalone app content will be treated as promotional. https://healthsensemag.com/policy-regulation/fda-names-nova-biomedical-statstrip-hospital-glucose-meterhttps://healthsensemag.com/policy-regulation/fda-names-nova-biomedical-statstrip-hospital-glucose-meterWed, 21 Oct 2026 12:00:00 -0800Policy & RegulationPrior scan data can stay on the Gen 2.0 meter's screen and send a glucose result to the wrong patient's record, according to the FDA. https://healthsensemag.com/explainers/how-device-user-fees-work-fda-readies-mdufahttps://healthsensemag.com/explainers/how-device-user-fees-work-fda-readies-mdufaWed, 21 Oct 2026 12:00:00 -0800ExplainersDevice makers pay FDA to review their submissions under a five-year deal that sets review goals; the next one would run from fiscal 2028 to 2032. https://healthsensemag.com/business/intuitive-q3-revenue-rises-22-450-million-antitrusthttps://healthsensemag.com/business/intuitive-q3-revenue-rises-22-450-million-antitrustWed, 21 Oct 2026 12:00:00 -0800BusinessThe da Vinci maker placed 546 systems in the quarter and recorded a one-time charge to settle a class action, while planned instrument price cuts weighed on its shares. https://healthsensemag.com/news/advamed-plans-industry-cybersecurity-standards-eyes-tariffs-fdahttps://healthsensemag.com/news/advamed-plans-industry-cybersecurity-standards-eyes-tariffs-fdaTue, 20 Oct 2026 12:00:00 -0800NewsAt The MedTech Conference in Boston, the trade group's leaders said a year of cyberattacks on device makers has pushed security to the top of their agenda. https://healthsensemag.com/treatments-trials/fda-approves-gsks-hibsago-first-antisense-drug-chronichttps://healthsensemag.com/treatments-trials/fda-approves-gsks-hibsago-first-antisense-drug-chronicTue, 20 Oct 2026 12:00:00 -0800Treatments & TrialsThe six-month injectable course is added to existing antiviral therapy, and in Phase III trials some patients were able to stop all hepatitis B treatment. https://healthsensemag.com/digital-health/ama-aha-stanford-researchers-press-fda-generative-aihttps://healthsensemag.com/digital-health/ama-aha-stanford-researchers-press-fda-generative-aiMon, 19 Oct 2026 12:00:00 -0800Digital HealthComments filed as the agency's docket on its August discussion paper closed call for real-world testing, clearer risk tiers and stronger postmarket monitoring. https://healthsensemag.com/treatments-trials/discs-bitopertin-meets-all-endpoints-pivotal-phase-3https://healthsensemag.com/treatments-trials/discs-bitopertin-meets-all-endpoints-pivotal-phase-3Mon, 19 Oct 2026 12:00:00 -0800Treatments & TrialsThe company plans to resubmit its application for the oral drug in erythropoietic protoporphyria by the end of 2026, months after the FDA turned down an accelerated approval request. https://healthsensemag.com/digital-health/simbiosys-gets-fda-clearance-tumorsight-risk-breast-cancerhttps://healthsensemag.com/digital-health/simbiosys-gets-fda-clearance-tumorsight-risk-breast-cancerFri, 16 Oct 2026 12:00:00 -0800Digital HealthThe AI tool scores five- and 10-year recurrence risk from routine MRI, pathology and clinical data for a common hormone receptor-positive subtype. https://healthsensemag.com/treatments-trials/fda-approves-genentechs-enspryng-subcutaneous-treatment-thyroid-eyehttps://healthsensemag.com/treatments-trials/fda-approves-genentechs-enspryng-subcutaneous-treatment-thyroid-eyeThu, 15 Oct 2026 12:00:00 -0800Treatments & TrialsThe approval follows a Phase III program in which one of two identically designed trials missed its primary endpoint, according to the company.