- 041TechnologySource · Medical Device Network
Medtech’s newest engineering discipline is cybersecurity
Cybersecurity is emerging as a core engineering discipline within medtech, according to Actalent's life sciences leadership. The sector must integrate security protocols from product conception onward, treating it as a strategic priority rather than an afterthought. This shift reflects rising regulatory scrutiny and the industry's growing exposure to digital threats as connected devices proliferate.
- 042RegulationSource · Medical Device Network
E2 wins FDA clearances for integrated Hēlo thrombectomy platform
E2 received FDA clearances for its integrated Hēlo thrombectomy platform, which includes the Hēlo Return system that aspirates blood during thrombectomy procedures and returns it to patients. The clearances enable broader clinical deployment of the VTE treatment workflow.
- 043MarketSource · Medical Device Network
Hiossen and GuidedSMILE collaborate on dental implant workflows
Hiossen Implants and GuidedSMILE announced a strategic partnership to expand access to guided full-arch implant procedures across North America. The collaboration combines Hiossen's implant systems with GuidedSMILE's digital planning and surgical guidance technology to streamline implant workflows for dental professionals.
- 044New productsSource · Medical Device Network
First patient treated in Spiro’s PULSAR asthma trial
Spiro Medical has enrolled the first patient in its PULSAR feasibility study, which evaluates a neuromodulation device for treating severe, uncontrolled asthma. The trial marks an early-stage clinical evaluation of the company's therapeutic approach to a patient population with limited options.
- 045MarketSource · Medical Device Network
Stryker invests $400m into CMR Surgical; secures future buyout option
Stryker Corporation has invested $400 million in CMR Surgical, a UK-based developer of robotic surgical systems for soft tissue procedures, and secured an option to acquire the company in the future. The investment provides Stryker access to the robotic-assisted surgery market and establishes a path toward potential full ownership of CMR Surgical's technology platform.
- 046MarketSource · Medical Device Network
Scarlet nabs $50m to grow AI-native medtech certification platform
Scarlet, a software certification platform for medical technology, raised $50 million in funding to expand its AI-native certification service across US and Asia-Pacific markets. The company provides certification services for medtech vendors, helping them navigate regulatory and compliance requirements.
- 047RegulationSource · MedCity News
Are Hospital Operating Rooms Ready For FDA’s Expectations for Surgical Robots?
The FDA released draft guidance on pre-market testing requirements for robotic surgical devices, prompting discussion about whether hospital operating room infrastructure can support the growing complexity of these systems. The guidance addresses clinical validation and technical standards for robotically-assisted surgery platforms.
- 048New productsSource · Medical Device Network
New study touts positive long-term data for Corcym’s sutureless aortic valve
Corcym presented seven-year follow-up data from its clinical study of Perceval Plus, a sutureless aortic valve, at the EACTS conference. The data demonstrated sustained cardiovascular benefit over the long-term follow-up period. Perceval Plus is used in surgical aortic valve replacement procedures.
- 049MarketSource · Medical Device Network
Ascensia partners with Sava to commercialise wearable microsensor
Ascensia Diabetes Care has entered a commercial and financing agreement with Sava Technologies to distribute Sava's wearable glucose microsensor. The partnership combines Ascensia's market presence in diabetes management with Sava's sensor technology, expanding the continuous glucose monitoring landscape.
- 050RegulationSource · Medical Device Network
FDA grants 510(k) clearance for Urolution Medical’s OpenFlo catheter
The FDA has granted 510(k) clearance to Urolution Medical for its OpenFlo urinary catheter. The clearance permits market distribution of the device in the United States. Details on specific clinical claims or differentiation versus predicate devices were not provided in the announcement.
- 051RegulationSource · Medical Device Network
Boston sues J&J subsidiary over alleged patent infringement for cardiology device
Boston Scientific has filed a lawsuit against J&J subsidiary Atraverse alleging patent infringement related to the Hotwire cardiology device system. Boston is seeking an injunction and damages. The case concerns intellectual property rights over the contested device technology.
- 052TechnologySource · Medical Device Network
AI’s use on existing radiology reports sees 360% rise in steatotic liver patient identification
Briya used its AIRE AI platform to retrospectively analyze existing radiology reports and identified 4,036 additional patients with steatotic liver disease, expanding a study population from 1,122 to 5,158 patients. The finding demonstrates AI's capability to extract clinically relevant insights from legacy imaging documentation without requiring new scans.
- 053MarketSource · Medical Device Network
MMI pockets $125m to back its robotic microsurgery’s market growth
MMI secured $125 million in Series D funding to expand commercial deployment of its Symani Surgical System, a robotic platform for microsurgery. The capital will support market growth and additional research into the technology, signaling investor confidence in the robotic microsurgery segment.
- 054MarketSource · Medical Device Network
SurGenTec signs licence deal with Allevion for Vantage
SurGenTec has secured an exclusive licence agreement with Allevion Medical to acquire rights to the Vantage spinal decompression system. The deal expands SurGenTec's portfolio in the minimally invasive spine surgery segment.
- 055New productsSource · Medical Device Network
Viome PRO introduces blood test for pancreatic cancer
Viome Life Sciences' clinical division Viome PRO launched CancerDetect Pancreatic, a physician-ordered blood test for detecting pancreatic ductal adenocarcinoma. The test represents a new product offering in the company's cancer diagnostics portfolio and targets early detection in a disease with historically poor prognosis.
- 056MarketSource · MedCity News
Startup Arboretum Sprouts, Bringing a Precision Medicine Approach to Common Diseases
Arboretum LifeSciences, a diagnostics and drug development startup, launched with $30 million in Series A funding. The company combines genetic testing with data analytics to identify disease patterns and inform drug development partnerships with major pharmaceutical firms and spawn new biotech ventures targeting common diseases.
- 057RegulationSource · Medical Device Network
Argus Cognitive’s paediatric autism diagnostic secures FDA clearance
Argus Cognitive received FDA clearance for Neurora, a diagnostic tool designed to support clinical assessment of autism in pediatric patients. The device is intended to complement rather than replace clinician judgment in diagnosis.
- 058TechnologySource · MedCity News
AI Can Flag Cognitive Decline Earlier — Health Systems Still Own What Happens Next
AI tools can identify cognitive decline earlier than traditional clinical methods, but health systems must establish workflows to translate algorithmic alerts into actionable clinical pathways. The article emphasizes that vendors and providers need coordinated decision-making before deployment to ensure risk signals in EHRs lead to accountable care processes rather than alert fatigue or missed interventions.
- 059RegulationSource · Medical Device Network
Sonorous wins FDA IDE for pulsatile tinnitus stent pivotal trial initiation
Sonorous Medical received FDA Investigational Device Exemption (IDE) approval to initiate a pivotal trial for BosSTENT, a stent designed to treat pulsatile tinnitus. The device previously earned FDA breakthrough device designation in February 2026, expediting its development pathway toward potential market clearance.
- 060New productsSource · Medical Device Network
BD reports nine-month AGILITY trial data for Revello stent
BD announced nine-month clinical data from the AGILITY Investigational Device Exemption trial evaluating its Revello Vascular Covered Stent in the iliac vascular segment. The trial is part of BD's regulatory pathway for the device, which is designed for treatment of iliac arterial disease.
- 061New productsSource · MedCity News
Teladoc Health Adds Contactless Vitals and Ambient AI Scribe to Virtual Visit Platform
Teladoc Health launched two AI-powered features for its Solo virtual care platform: contactless vital signs monitoring and an ambient AI scribe tool. The capabilities are designed for hospitals and health systems to integrate into remote patient visits, enabling clinicians to capture vitals without physical contact and generate automated clinical documentation during telehealth encounters.
- 062MarketSource · Medical Device Network
Zenflow raises $52m for BPH implant and inks US distribution pact with Cook Medical
Zenflow raised $52 million in funding and signed a US distribution agreement with Cook Medical for its Spring implant, a device cleared by the FDA in December 2025 to treat benign prostatic hyperplasia symptoms. The funding and partnership expand commercial availability of the urology-focused implant in the US market.
- 063MarketSource · MedCity News
From Distributor to Disruptor: Amazon’s Healthcare Flex
Amazon is expanding its healthcare footprint beyond pharmacy and clinic acquisitions, positioning itself to reshape pharmaceutical distribution and the broader healthcare supply chain. The move signals a strategic shift toward vertical integration and control over the commercialization pathway for drugs and medical products, potentially disrupting traditional distributor relationships.
- 064MarketSource · Medical Device Network
OXOS Medical wins $24m BARDA contract for next-gen portable x-ray system
OXOS Medical secured a $24.4 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop a next-generation portable X-ray system. OXOS will match the federal contribution, bringing total project value to $48.8 million. The partnership supports advancement of field-deployable imaging technology for emergency and remote medical settings.
- 065New productsSource · Medical Device Network
Epicore and MECFA partner on wearable cystic fibrosis test
Epicore Biosystems has partnered with MECFA to develop a wearable microfluidic platform for cystic fibrosis monitoring and management. The collaboration aims to advance Epicore's wearable technology for CF patient care and disease management applications.
- 066MarketSource · Medical Device Network
Cambridge Heartwear receives $243m tender for HeartSense wearable
The UK NHS Supply Chain awarded a £243.7 million tender to Cambridge Heartwear to supply its HeartSense cardiac monitoring wearable. The contract represents a significant procurement win for the vendor's remote patient monitoring technology.
- 067TechnologySource · Medical Device Network
Overcoming the challenges of engineering sensor-rich pulsed field ablation (PFA) catheters
Pulsed field ablation catheters are advancing through improved sensing and wire technologies that enable smaller, safer device designs. The article examines engineering challenges in integrating advanced sensors into PFA catheter platforms, a minimally invasive cardiac ablation tool used to treat arrhythmias.
- 068RegulationSource · Medical Device Network
Eye implant triggers sight improvements in GA at 36 months, pivotal study finds
Science Corporation's PRIMA retinal implant demonstrated sustained sight improvements in geographic atrophy patients at 36 months in its pivotal trial, according to newly published results. The findings arrive as the FDA reviews the device for US market approval. The implant addresses a key indication in age-related macular degeneration with no current treatment options.
- 069RegulationSource · Medical Device Network
Happy Health’s ring secures FDA clearance for blood pressure measurement
Happy Health's wearable ring device has received FDA clearance for blood pressure measurement, expanding its approved indications beyond its prior clearance for sleep apnoea diagnosis and monitoring. The clearance adds a new clinical function to the existing homecare monitoring platform.
- 070RegulationSource · Medical Device Network
UK government backs healthcare commission blueprint for AI-enabled devices
The UK government has endorsed a healthcare commission blueprint for regulating AI-enabled medical devices, aiming to balance innovation encouragement with safety guardrails. The policy shift signals a regulatory framework change for AI-integrated devices in the British market, affecting how vendors develop and bring such products to market.
- 071New productsSource · Medical Device Network
EASD 2026: MiniMed touts Smart MDI system alert response benefits in type 1 diabetes patients
Medtronic's MiniMed presented data at EASD 2026 showing that type 1 diabetes patients using its Smart MDI (multiple daily injection) system who responded promptly to alerts achieved approximately 8 percentage points higher time in range compared to lower-response cohorts. The Smart MDI system provides alert functionality to support diabetes management.
- 072MarketSource · Medical Device Network
CellCarta, Waters Corporation collaborate on companion diagnostics
CellCarta and Waters Corporation have formed a strategic partnership to develop companion diagnostics (CDx) and next-generation flow cytometry solutions for pharmaceutical and biotechnology customers. The collaboration combines CellCarta's diagnostic capabilities with Waters' analytical instrumentation expertise to advance CDx platforms and flow cytometry technology.
- 073RegulationSource · Medical Device Network
FDA clears Abbott’s CardioMEMS HF system updates
Abbott received FDA clearance for software updates to its CardioMEMS HF System, a remote monitoring platform for heart failure patients. The updates introduce new digital features enabling patients to track cardiac data on mobile devices, expanding the system's remote monitoring and data management capabilities.
- 074MarketSource · Medical Device Network
GE HealthCare agrees to acquire SOFIE Biosciences in $945m deal
GE HealthCare has agreed to acquire SOFIE Biosciences, a PET radiopharmaceuticals contract manufacturer owned by Trilantic North America, for $945 million in a cash transaction expected to close in the first half of 2027. The deal expands GE HealthCare's radiopharmaceutical manufacturing and distribution capabilities.
- 075RegulationSource · Medical Device Network
Autonomix secures Canadian patent for catheter-based technologies
Autonomix Medical obtained a Canadian patent for its catheter-based tissue monitoring and therapy delivery technology from the Canadian Intellectual Property Office. The patent protection expands the company's IP portfolio for its minimally invasive catheter platform across North America.
- 076MarketSource · Medical Device Network
Averly Health launches in UK to advance cardiometabolic care
Averly Health has launched operations in the UK to expand its cardiometabolic care platform. The move targets conditions including obesity and type 2 diabetes, representing a geographic expansion of the company's digital health offering to a new market.
- 077New productsSource · Medical Device Network
First US commercial procedures completed with Emboline’s device
Emboline completed the first two commercial US procedures using its Emboliner Embolic Protection System for transcatheter aortic valve implantation (TAVI). The device is designed to protect patients during valve replacement by capturing embolic debris. The milestone marks the system's entry into routine clinical use in the United States following regulatory clearance.
- 078TechnologySource · MedCity News
Healthcare Privacy Leaders Look to AI to Improve Monitoring and Data Breach Investigations
Healthcare privacy leaders are adopting AI tools to enhance data security monitoring and investigate breaches more efficiently, according to discussions at a recent privacy symposium. The shift reflects growing interest in using machine learning to identify and respond to privacy risks within healthcare organizations.
- 079MarketSource · MedCity News
Parakeet Health Secures $10M for Conversational Agentic Platform
Parakeet Health raised $10 million in Series A funding led by Canvas Ventures to develop a conversational agentic platform. The round included participation from Blank Space Ventures, StoryHouse Ventures, and HMC INQ. The platform targets healthcare organizations seeking AI-driven automation for administrative and clinical workflows.
- 080RegulationSource · Medical Device Network
Boston Scientific recalls spinal cord stimulators
Boston Scientific expanded a recall of Infinion CX leads used in its spinal cord stimulator system after over 1,000 injuries were reported. The recall affects a key component of the company's neuromodulation product line.