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What's moving the medical supply market.

Curated from medtech publications. Product launches, FDA clearances, M&A, technology shifts — rewritten as short briefs, linked back to the source. Filter by theme below.

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§001MarketSeptember 4, 2026

Oracle Health Execs Subpoenaed After VA Contract Costs Nearly Triple

The House VA Committee voted unanimously to subpoena Oracle Health executives Larry Ellison and Mike Sicilia after the Department of Veterans Affairs electronic health record contract swelled from $10 billion to $27 billion. Oracle had previously pledged to Congress it would cover overages beyond the original cap. The cost escalation has triggered congressional scrutiny of the vendor's accountability and contract performance.

Source · MedCity NewsRead brief

§002RegulationSeptember 4, 2026

Boston Scientific’s SCS leads linked to 1,081 serious injuries in FDA alert

Boston Scientific faced an FDA alert linking its spinal cord stimulation (SCS) leads to 1,081 serious injuries. The company operates in a market where multiple medtech vendors are defending personal injury lawsuits tied to SCS system malfunctions, signaling broader reliability concerns across the spinal neuromodulation sector.

Source · Medical Device NetworkRead brief

§003RegulationSeptember 4, 2026

WHO greenlights Cepheid’s Ebola diagnostic amid ongoing Bundibugyo outbreak

The WHO has granted approval for Cepheid's Ebola diagnostic test during an ongoing Bundibugyo virus outbreak in Central Africa, declared a public emergency in May 2026. The clearance enables broader deployment of the rapid diagnostic platform to support outbreak response efforts in affected regions.

Source · Medical Device NetworkRead brief

§004RegulationSeptember 4, 2026

Globus Medical’s Excelsius3D imaging system receives CE mark

Globus Medical received CE mark approval for its Excelsius3D imaging system, enabling commercial distribution in the European Union and UK. The clearance expands the platform's market access beyond existing approvals.

Source · Medical Device NetworkRead brief

§005New productsSeptember 4, 2026

HR HealthCare rolls out Liv catheter for female self-catheterisation

HR HealthCare launched the Liv Pre-lubricated Intermittent Catheter, a device designed for female self-catheterization to support bladder health management. The product addresses a specific segment of the intermittent catheterization market with pre-lubricated technology.

Source · Medical Device NetworkRead brief

§006RegulationSeptember 3, 2026

FDA clears Heartvue’s cardiac image evaluation software

The FDA has cleared Heartvue.Proton, a software tool designed to streamline the evaluation of cardiovascular MRI images. The clearance enables the vendor to market the cardiac image analysis platform to healthcare facilities performing cardiac imaging studies.

Source · Medical Device NetworkRead brief

§007MarketSeptember 3, 2026

IVL adoption grows, but consistency remains the real test

Intravascular lithotripsy (IVL) adoption is increasing in interventional cardiology, though widespread implementation remains limited by practical constraints. The trend reflects growing clinical acceptance, but standardization and consistency across centers will determine whether IVL becomes routine practice.

Source · Medical Device NetworkRead brief

§008MarketSeptember 3, 2026

Elucid raises $55m to advance cardiovascular diagnostic portfolio

Elucid announced a $55 million funding round to accelerate commercial expansion of its cardiovascular diagnostic platform, including its Plaque-IQ diagnostic tool. The proceeds will support scaling of the clinical platform serving cardiologists and related specialists.

Source · Medical Device NetworkRead brief

§009RegulationSeptember 3, 2026

FDA clears Hamamatsu NanoZoomer S20MD and S540MD slide scanners

Hamamatsu Photonics received FDA 510(k) clearance for the NanoZoomer S20MD and S540MD slide scanner systems. These digital pathology platforms enable high-resolution scanning and analysis of microscope slides for laboratory and clinical use.

Source · Medical Device NetworkRead brief

§010MarketSeptember 3, 2026

PixCell Medical and Inter Medico to distribute HemoScreen across Canada

PixCell Medical has partnered with Inter Medico to distribute its HemoScreen haematology analyser across Canada. The deal expands PixCell's geographic footprint into the Canadian market through a regional distributor agreement.

Source · Medical Device NetworkRead brief

§011New productsSeptember 2, 2026

This Device Could Prevent Lung Biopsy’s Most Common — and Costly — Complication

Selio Medical announced FDA clearance for a hydrogel device designed to seal puncture sites during CT-guided lung biopsies, preventing pneumothorax complications that occur in up to one-third of the 800,000+ procedures performed annually in the U.S. The device addresses a significant clinical and economic burden associated with this common diagnostic procedure.

Source · MedCity NewsRead brief

§012TechnologySeptember 2, 2026

The Healthcare Inflection Point: AI Can’t Fix 1990s Technology

Healthcare systems cannot achieve meaningful transformation by applying AI tools to legacy infrastructure and outdated workflows, according to analysis on MedCity News. The piece argues that isolated technology improvements fail to drive enterprise-wide change when deployed atop 1990s-era systems rather than integrated into fundamentally redesigned care delivery processes. Supplier vendors face pressure to address interoperability and modernization challenges.

Source · MedCity NewsRead brief

§013MarketSeptember 2, 2026

Flosonics awarded $70m BARDA contract for wearable’s advance into trauma care

Flosonics Medical received a $70 million BARDA contract to develop FloPredict, an AI algorithm designed to support trauma care and mass casualty event response. The contract funds advancement of the company's wearable technology platform for emergency and critical care applications.

Source · Medical Device NetworkRead brief

§014TechnologySeptember 2, 2026

Inside Huawei’s next health play: turning wearables into medical research

Huawei is expanding its digital health strategy by advancing wearable technology toward clinical-grade monitoring capabilities. The company aims to leverage its wearable platform for medical research applications, positioning consumer devices to collect data suitable for clinical use and research workflows.

Source · Medical Device NetworkRead brief

§015RegulationSeptember 2, 2026

Vara nets first CE mark for autonomous AI breast cancer screening tool

Vara received CE mark approval for its autonomous AI-powered breast cancer screening triage system. The clearance signals regulatory acceptance of the company's AI-driven approach to cancer screening workflows, as machine learning tools become more integrated into diagnostic imaging pathways.

Source · Medical Device NetworkRead brief

§016RegulationSeptember 2, 2026

Health Canada issues licences to Fujirebio’s Lumipulse assays

Fujirebio received Class II Medical Device Licences from Health Canada for its Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays. These blood-based biomarker tests are used in neurodegenerative disease diagnostics. The clearances expand regulatory authorization for the assays beyond prior markets.

Source · Medical Device NetworkRead brief

§017MarketSeptember 2, 2026

Medtronic raises FY27 outlook after reporting strong Q1 growth

Medtronic raised its fiscal 2027 outlook following strong first-quarter results, with cardiac ablation solutions delivering 29.5% year-over-year growth as the electrophysiology business's top performer. The company's positive guidance reflects momentum across its portfolio segments.

Source · Medical Device NetworkRead brief

§018RegulationSeptember 2, 2026

FDA grants 510(k) clearance to Medibyt’s CPETWise solution

Medibyt, an Israeli digital health company, received FDA 510(k) clearance for CPETWise, a software solution designed to assist in the analysis and interpretation of cardiopulmonary exercise testing (CPET). The clearance enables the company to market the tool in the US.

Source · Medical Device NetworkRead brief

§019RegulationSeptember 1, 2026

How Vitestro’s first-of-its-kind Aletta robot autonomously draws blood

Vitestro received FDA de novo classification in August 2026 for its Aletta robotic phlebotomy system, which autonomously performs blood draws from tourniquet placement through bandaging. The FDA designation recognizes the device as an innovative approach to blood collection addressing a critical public health need.

Source · Medical Design & OutsourcingRead brief

§020New productsSeptember 1, 2026

ESC 2026: Abbott presents positive longer-term dual ablation catheter data

Abbott presented longer-term clinical data for its TactiFlex Duo ablation catheter at ESC 2026, a dual-modality device combining pulsed-field and radiofrequency ablation for atrial fibrillation treatment. The data demonstrated positive outcomes with the dual-technology approach, which offers clinicians flexibility in catheter selection during AF procedures.

Source · Medical Device NetworkRead brief

§021TechnologySeptember 1, 2026

ESC 2026: Biomarker indicates coronary inflammation from non-contrast CT

Caristo's FAI biomarker has demonstrated capability in assessing coronary inflammation using non-contrast CT scans and predicting cardiovascular death, according to data presented at ESC 2026. The biomarker works with existing imaging infrastructure without requiring contrast agents, potentially simplifying workflow for risk stratification in coronary artery disease assessment.

Source · Medical Device NetworkRead brief

§022RegulationSeptember 1, 2026

GE HealthCare secures CE mark for Photonova Spectra CT system

GE HealthCare has obtained CE mark approval for its Photonova Spectra photon-counting CT system, clearing the device for commercial distribution in European markets. The certification represents regulatory progression for the photon-counting imaging technology platform.

Source · Medical Device NetworkRead brief

§023MarketSeptember 1, 2026

Scan.com secures $220m to expand US medical imaging network

Scan.com raised $220 million in combined equity and debt financing to expand its US medical imaging network. The funding will support the company's growth in diagnostic imaging services and infrastructure across the country.

Source · Medical Device NetworkRead brief

§024TechnologyAugust 31, 2026

How to make smarter polymer choices for disposable drug delivery devices

LyondellBasell examines material selection for injection-molded disposable drug delivery devices, addressing how resin choice impacts tooling design, molding consistency, sterilization performance, and manufacturing costs. The article guides suppliers through polymer decision-making for single-use delivery systems.

Source · Medical Design & OutsourcingRead brief

§025TechnologyAugust 31, 2026

MIT researchers create breathable hydrogel for less irritation and longer wear

MIT engineers have developed a breathable hydrogel that reduces moisture trapping and skin irritation while extending wear time. The material, made of water and polymer, is designed for use in medical patches, wound dressings, implant attachment, and drug delivery applications. The breathable formulation addresses a limitation of conventional hydrogels that accumulate moisture and sweat under prolonged wear.

Source · Medical Design & OutsourcingRead brief

§026TechnologyAugust 30, 2026

Hospitals Are All In on AI, but Testing and Oversight Haven’t Caught Up

A new report reveals that over 90% of U.S. health systems have deployed third-party AI tools, but fewer than half have established infrastructure to test and validate those tools before clinical use. The finding highlights a gap between rapid AI adoption and the governance and validation processes needed to ensure safety and efficacy in patient care environments.

Source · MedCity NewsRead brief

§027TechnologyAugust 28, 2026

Epic MyChart Phishing Scam Hits Health Systems: What Providers Should Do

More than a dozen health systems are warning patients of a phishing campaign impersonating Epic's MyChart patient portal using fake Medicare rewards and login pages. Security experts attribute the campaign's success to increasingly sophisticated fakes and note that providers bear responsibility for communicating authentication best practices and building patient trust to counter such attacks.

Source · MedCity NewsRead brief

§028New productsAugust 28, 2026

This minimally invasive ablation device shows promise to keep pounds off after GLP-1s

Fractyl Health's Revita system, a minimally invasive hydrothermal ablation device, demonstrated efficacy in maintaining up to 84% of weight loss achieved with GLP-1 medications one year after discontinuation. The single-use catheter targets the duodenal mucosa in the proximal small intestine. The device represents a potential adjunctive approach to weight management following GLP-1 therapy cessation.

Source · Medical Design & OutsourcingRead brief

§029New productsAugust 28, 2026

ESC 2026: Heartflow’s fractional flow reserve tool reduces unnecessary coronary interventions

Heartflow presented data at ESC 2026 showing its fractional flow reserve (FFR) technology reduced unnecessary invasive coronary angiography (ICA) by 44% at one year, compared to 22% reduction with coronary CT angiography (CCTA) alone. The tool integrates with existing imaging workflows to guide intervention decisions in coronary artery disease assessment.

Source · Medical Device NetworkRead brief

§030MarketAugust 28, 2026

Kardium secures $22.5m funding for pulsed field system manufacturing

Kardium secured up to $22.5 million in funding from the Government of Canada to support manufacturing of its Globe Pulsed Field System in British Columbia. The pulsed field ablation technology is used for cardiac arrhythmia treatment. The funding backs production capacity expansion for the minimally invasive cardiac device.

Source · Medical Device NetworkRead brief

§031New productsAugust 28, 2026

Philips and Imricor introduce MR lab solution for cardiac interventions

Philips and Imricor Medical Systems launched a new iMR lab solution designed for cardiac interventions. The system integrates MR imaging with interventional capabilities to support real-time guidance during cardiac procedures, combining Philips' imaging platform with Imricor's MR-compatible cardiac technology.

Source · Medical Device NetworkRead brief

§032TechnologyAugust 27, 2026

MIT awarded $18M for new materials science research hub aimed at advancing X-ray imaging

The National Science Foundation awarded MIT $18 million over six years to establish a materials research science and engineering center focused on advanced materials for medical imaging, including X-ray imaging applications, alongside work on sustainable metals and semiconductors. The center will conduct R&D into material innovations that could enable next-generation imaging device development.

Source · Medical Design & OutsourcingRead brief

§033New productsAugust 27, 2026

Datavant’s New Platform Could Cut Record Retrieval Time from Days to Hours

Datavant launched a provider exchange platform designed to digitize medical record requests, replacing traditional fax-based workflows. The system provides real-time visibility into request status and reduces administrative burden on clinical staff by accelerating retrieval from days to hours.

Source · MedCity NewsRead brief

§034RegulationAugust 27, 2026

NICE recommends NHS funding for Bridge to Life’s liver perfusion system

The UK's National Institute for Health and Care Excellence (NICE) recommended NHS funding for Bridge to Life's VitaSmart liver perfusion system, one of four devices approved for routine coverage. The recommendation signals market access and reimbursement pathway clearance for the organ perfusion technology in the UK healthcare system.

Source · Medical Device NetworkRead brief

§035RegulationAugust 27, 2026

Paradromics gets FDA nod for broader BCI device compatibility

Paradromics received FDA approval to expand compatibility of its investigational brain-computer interface (BCI) system with a broader range of personal computing devices. The clearance widens the potential integration options for the BCI platform, allowing it to work with more standard consumer and enterprise computing hardware.

Source · Medical Device NetworkRead brief

§036MarketAugust 27, 2026

Boston Scientific impacted by ongoing cyberattack

Boston Scientific disclosed a cyberattack discovered on 25 August that has caused global operational disruptions. The incident affects the medical device supplier's IT systems and poses supply-chain risks to customers and distributors relying on the company's ordering, fulfillment, and support infrastructure.

Source · Medical Device NetworkRead brief

§037MarketAugust 27, 2026

PENTAX broadens MAGENTIQ EYE partnership for global AI colonoscopy

PENTAX Medical has expanded its partnership with MAGENTIQ EYE to accelerate global deployment of AI-assisted colonoscopy technology. The collaboration aims to increase adoption of AI-enabled diagnostic capabilities across PENTAX's endoscopy portfolio in international markets.

Source · Medical Device NetworkRead brief

§038MarketAugust 26, 2026

Onos Health Raises $17M to Expand AI-Powered Behavioral Health Platform

Onos Health closed a $17M Series A funding round led by Costanoa, with participation from Flare Capital Partners and CVS Health Ventures. The funding will support expansion of the company's AI-powered behavioral health platform.

Source · MedCity NewsRead brief

§039TechnologyAugust 26, 2026

This researcher’s development could inspire new and next-gen neuromod technologies

Dr. Stavros Zanos and researchers at Northwell Health's Feinstein Institutes completed a comprehensive human vagus nerve anatomical map designed to inform development of next-generation neuromodulation therapies. The detailed mapping of vagus nerve anatomy could enable more precise and safer device targeting for autonomic nervous system modulation in heart rate, breathing, digestion, and immune function.

Source · Medical Design & OutsourcingRead brief

§040MarketAugust 26, 2026

Cyberattack Disrupts Boston Scientific’s Operations: 7 Things to Know

Boston Scientific disclosed a cyberattack affecting its global IT systems and order-fulfillment capabilities, with no timeline given for service restoration. The incident marks the latest major breach to hit a tier-one medtech vendor in 2026, following similar attacks on Stryker, Medtronic, and Abbott. Supply chain disruptions and operational impacts remain uncertain pending system recovery.

Source · MedCity NewsRead brief