
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.

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....

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....

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...

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...

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...

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...
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....
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,...

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...

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...

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....

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...