Medical Device & Technology

The company says the device is roughly 30% smaller than its prior wearable and is built around research from more than 10,000 members and caregivers.

The 510(k) clearance covers software that flags signs of the underdiagnosed condition from a standard 12-lead ECG in patients 40 and older with cardiovascular symptoms.

New device pairs with the company's existing external catheters to offer a full at-home management option for the estimated 13 million Americans living with urinary incontinence

The BP Go device measures blood pressure through the finger instead of a traditional arm cuff, and Wellvii says the clearance supports its push into remote patient monitoring.

The extravascular eVAD System avoided vascular access in a SCAI Stage D patient in São Paulo, Brazil, ahead of a planned U.S. IDE study.

Crytica Security's RDAi system installs a sub-100 KB software "Probe" inside each device to monitor for unauthorized changes, aiming to catch tampering that network-based tools alone can miss.

The deal gives surgeons a new registration option for AR navigation, potentially expanding access for regional hospitals and ambulatory surgery centers.

The preferred portfolio deal covers 3D mapping, intracardiac imaging, and both radiofrequency and pulsed field ablation technologies to expand outpatient arrhythmia care.

The next-generation implantable tibial neuromodulation device treats urgency urinary incontinence, with a limited U.S. launch planned for the fourth quarter of 2026.

The 510(k)-cleared, CE-marked laptop systems bring AI-powered imaging and workflow tools to point-of-care settings outside traditional imaging departments

The procedure at the Hospital of the University of Pennsylvania used a faster, more maneuverable version of the company's vCLAS Ultra-Low Temperature Ablation system to treat a patient whose ventricular tachycardia had resisted radiofrequency and alcohol ablation.

Two 510(k) clearances expand the synthetic bone graft's indications to include pediatric and tumor-related spinal fusion cases.

The 510(k) clearance adds a porous 3D-printed titanium interbody with dual spike-and-screw fixation to the company's Saber cervical platform.

The 510(k) clearance enables the ION-L Lumbar Facet Fixation System to work with Medtronic's StealthStation platform, adding navigation compatibility to a zero-profile fixation device.

The collaborations pair Karl Storz's 3D visualization and OR integration technology with Moon Surgical's AI-native Maestro platform and Sovato's remote surgery capabilities, launching first in the U.S. ahead of a global rollout.

Gentherm's ThermAffyx Patient Safety System integrates active warming with anti-slip securement in a single Class II platform, targeting hypothermia risk during the more than 3 million robotic-assisted procedures performed worldwide each year.

MultiDimension Technology's TMR1370 draws as little as 30 nanoamps, enabling more than two years of standby operation in continuous glucose monitoring devices.

The multicenter study is evaluating whether localized cryotherapy, guided by AI-enabled imaging, can stabilize non-obstructive high-risk plaques before they trigger a heart attack.

AcuityMD's 2026 benchmark report of 150 MedTech reps finds AI users report stronger quota attainment and time savings, even though most still rely on general-purpose tools for basic tasks.

The non-invasive histotripsy platform can now be commercialized across Europe and other CE Mark-recognizing markets following backing from #HOPE4LIVER pivotal trial data.

The Thermocool Smarttouch SF Platform now lets electrophysiologists deliver radiofrequency or pulsed field energy through a single catheter integrated with the Carto mapping system.

The 510(k) clearance for the LARS ACJ implant marks the U.S. debut of a synthetic ligament platform already used in more than 250,000 patients worldwide over three decades.

The Swiss spine technology company says the system requires no capital investment and can be prepared in under two minutes, aiming to remove longstanding operational barriers to broader adoption of minimally invasive spine procedures.

Tandem Diabetes Care expands its Control-IQ+ automated insulin delivery system to work with Abbott's newest 15-day continuous glucose monitor across the United Kingdom, Switzerland, Sweden, Finland and Italy, with Belgium, the Netherlands and Germany slated to follow later this year.

Clearance is backed by a 159-patient, 10-site study showing higher response rates than physical therapy alone