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.
Forus, an AI-powered diagnostic imaging software company, raised $150 million in Series C funding led by Bain Capital Ventures, valuing the company at $3 billion. The round included participation from Thrive Capital, General Catalyst, Accel, Redpoint, and eight other venture firms.
LEP Biomedical is developing a dissolvable implant designed to replace post-operative eye drops following glaucoma surgery. The device aims to improve patient compliance during recovery, addressing a significant driver of surgical failure rates that can reach 40%. The implant delivers medication over weeks without requiring patient self-administration.
OncoSil Medical has secured A$5.6 million ($4.03 million) in funding commitments to support the launch of its single-use brachytherapy device for cancer treatment. The capital raise will enable commercialization of the device.
Boston Scientific experienced a cyberattack on August 25 that disrupted global operations. The company is now in recovery mode following the incident. No details on impact scope, systems affected, or timeline to full restoration were provided.
Nyxoah, a Belgium-based medical device company, has implanted the first patient in its BREATHE post-approval study of the Genio system for obstructive sleep apnea. The Genio is an implantable neurostimulation device designed to treat OSA by stimulating the hypoglossal nerve.
Life science manufacturers face increasing regulatory pressure to transition from paper-based compliance systems to digital alternatives. The shift addresses enforcement trends and helps suppliers maintain documented compliance with manufacturing and quality standards.
Powerful Medical received FDA approval for Queen of Hearts, an AI model that analyzes ECG readings to detect STEMI and STEMI-equivalent patterns associated with acute coronary syndrome. The software is designed to aid in rapid identification of heart attack risk.
Philips launched the eV14-2v transvaginal transducer, expanding its ultrasound portfolio for obstetrics and gynecology applications. The transducer is designed for use in reproductive health imaging procedures.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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