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Medical Design & Outsourcing

Medical Design & Outsourcing

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Design, development, and outsourcing in medical devices and medtech.

Recent Posts

Zimmer Biomet Says Its SynTuition Algorithm Enhances Diagnostic Certainty
News•Feb 25, 2026

Zimmer Biomet Says Its SynTuition Algorithm Enhances Diagnostic Certainty

Zimmer Biomet announced that its machine‑learning tool SynTuition dramatically improves diagnostic certainty for periprosthetic joint infection (PJI). In a study of 274 real‑world cases, the algorithm matched expert diagnoses 96% of the time, outpacing a pooled physician group that achieved 91% accuracy and left 38‑48% of cases undecided. SynTuition delivered a definitive diagnosis in 87% of ambiguous cases and projected a $4,000 cost saving per suspected infection. The tool leverages an 11‑biomarker Synovasure panel to generate a continuous probability score without relying on cultures.

By Medical Design & Outsourcing
3 Lessons Learned From Developing a Novel Neurotechnology Device
News•Feb 24, 2026

3 Lessons Learned From Developing a Novel Neurotechnology Device

QuantalX Neuroscience’s Delphi‑MD, a hybrid TMS‑EEG platform powered by AI, received FDA de novo classification in November 2025 and entered commercial launch in February 2026. The device delivers real‑time, age‑adjusted brain‑function assessments by comparing patient data to a cleared normative database. CEO Dr....

By Medical Design & Outsourcing
Croom Medical Breaks Ground on R&D Site in Ireland
News•Feb 20, 2026

Croom Medical Breaks Ground on R&D Site in Ireland

Croom Medical has broken ground on ACOT, a 38,000‑square‑foot Advanced Centre of Orthopaedic Technologies in Croom, County Limerick. The project represents the company’s largest capital outlay in its 42‑year history and will serve as a combined R&D and industrialisation hub....

By Medical Design & Outsourcing
Leica Launches CM1950 Cryostat with DualEcoTec Cooling System
News•Feb 20, 2026

Leica Launches CM1950 Cryostat with DualEcoTec Cooling System

Leica Biosystems, a Danaher subsidiary, unveiled the Leica CM1950 cryostat equipped with DualEcoTec cooling. The device cools specimens up to three times faster and chambers up to twice as fast, slashing setup and case times. It employs a near‑zero global...

By Medical Design & Outsourcing
MIT Researchers Develop Miniaturized Breast Ultrasound Wearable
News•Feb 19, 2026

MIT Researchers Develop Miniaturized Breast Ultrasound Wearable

MIT researchers have created a miniature ultrasound system roughly the size of a smartphone and costing about $300, capable of capturing real‑time three‑dimensional breast images. The device uses a square‑array probe with CODA geometry, reducing transducer elements from 1,024 to...

By Medical Design & Outsourcing
Master Bond Debuts UV26DCMed Dual-Cure Adhesive
News•Feb 19, 2026

Master Bond Debuts UV26DCMed Dual-Cure Adhesive

Master Bond introduced UV26DCMed, a single‑component, dual‑cure adhesive for medical device assembly that combines UV light for rapid fixturing with a heat bake for full polymerization. The formulation tolerates repeated sterilization methods—including steam autoclave, ethylene oxide, glutaraldehyde, and hydrogen‑peroxide—while meeting...

By Medical Design & Outsourcing
The Blueprint for Commercializing Breakthrough Healthtech
News•Feb 18, 2026

The Blueprint for Commercializing Breakthrough Healthtech

AI‑driven medtech firms must prove tangible ROI for patients, providers and payers to move from lab to bedside. Brent Ness outlines three pillars—capital efficiency with payer alignment, rigorous evidence and reimbursement pathways, and operational scalability paired with strong IP—that determine...

By Medical Design & Outsourcing
Enlil Launches Milestone View for Its Medtech Product Lifecycle Traceability Software
News•Feb 17, 2026

Enlil Launches Milestone View for Its Medtech Product Lifecycle Traceability Software

Enlil unveiled Milestone View, the industry’s first evidence‑based milestone interface for medical device product development. The new capability embeds directly within Enlil’s unified traceability platform, linking each milestone to underlying requirements, design outputs, risk controls, change histories and regulatory evidence....

By Medical Design & Outsourcing
How CathWorks Leaned on Its Partner Medtronic to Succeed
News•Feb 17, 2026

How CathWorks Leaned on Its Partner Medtronic to Succeed

CathWorks, an AI‑driven startup that creates non‑invasive FFR assessments from routine angiograms, survived the pandemic by leaning on Medtronic’s early minority investment and strategic guidance. After automating its 3‑D coronary modeling to cut analysis time from 22 minutes to two,...

By Medical Design & Outsourcing
This Startup Developed a First-of-Its-Kind Brain Function Assessment Device
News•Feb 17, 2026

This Startup Developed a First-of-Its-Kind Brain Function Assessment Device

QuantalX secured FDA de novo clearance for Delphi‑MD, a first‑of‑its‑kind device that fuses transcranial magnetic stimulation (TMS) with electroencephalography (EEG) to deliver real‑time brain network function assessments. The system leverages proprietary algorithms and an age‑correlated normative database to generate actionable...

By Medical Design & Outsourcing
Lubrizol Launches Tolerathane TPU for Implantable Medical Devices
News•Feb 11, 2026

Lubrizol Launches Tolerathane TPU for Implantable Medical Devices

Lubrizol has launched Tolerathane™ TPU, a medical‑grade thermoplastic polyurethane designed for implantable devices. The material offers superior resistance to oxidative and hydrolytic degradation while maintaining exceptional softness and mechanical resilience. It integrates with standard thermal processing, enabling thinner‑wall, miniaturized designs...

By Medical Design & Outsourcing
AdvaMed Names New EVP of Technology and Regulatory Affairs
News•Feb 10, 2026

AdvaMed Names New EVP of Technology and Regulatory Affairs

AdvaMed announced Melissa Torres as its new executive vice president of technology and regulatory affairs, succeeding long‑time leader Janet Trunzo. Torres arrives with more than two decades of FDA leadership, most recently as associate director for international affairs at CDRH....

By Medical Design & Outsourcing
Symmetry Laser Acquires ArcRev to Expand Precision Laser Cutting Capabilities
Deals•Feb 5, 2026

Symmetry Laser Acquires ArcRev to Expand Precision Laser Cutting Capabilities

Symmetry Laser, a provider of precision laser cutting solutions for medical devices, announced the completion of its acquisition of ArcRev, a specialist laser cutting firm. The deal expands Symmetry Laser’s technical capabilities, manufacturing capacity, and lean manufacturing expertise, strengthening its...

Medical Design & Outsourcing