Device Pipeline and Approvals

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.

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.

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.

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

The premarket approval of United Therapeutics' LungFX device lets transplant programs outsource lung re-evaluation to dedicated facilities rather than building in-house EVLP capacity.

FDA clears Life Spine's VersaLift expandable interbody system, featuring a 6mm starting height for constrained anatomy

EchoNext, developed by Pathway Labs, is now available on OpenEvidence after receiving FDA clearance for six indications

New AI-powered sensor on Radius VSM flags early signs of opioid-induced respiratory depression in hospitalized patients

Clearance extends the company's near-infrared fluorescence imaging to open procedures in the U.S., letting surgical teams add ICG visualization without new capital investment.

The spinal fixation system is designed to provide surgeons with a modular platform that can be customized for a wide range of patient anatomies and surgical procedures, including complex deformity and revision cases.

South Korean company plans U.S. launch through partnership with sensor technology firm

Software platform uses consumer smartwatches and blood pressure cuffs to estimate cardiac hemodynamics for heart failure patients at home

AI-powered software estimates cardiac pressure noninvasively through wearable sensor

New device adds airflow, oxygen and snoring analysis capabilities to chin-worn home testing platform

Device is intended to provide rapid nerve identification and functional evaluation for both large and small nerves during surgery

System uses a non-invasive focused ultrasound technology designed to mechanically liquefy and destroy targeted tissue without surgery, radiation or thermal energy.

Clearance authorizes use of the system by qualified and trained healthcare professionals and marks a key regulatory milestone for the company as it expands its artificial intelligence-enabled imaging platform.

Rapid Medical says its TIGERTRIEVER 25 device is designed to improve clot retrieval in difficult large vessel occlusions, as advances in mechanical thrombectomy continue to expand stroke treatment options

Device is intended for use in minimally invasive cardiac procedures that require access to the left atrium, a critical but technically challenging step in many structural heart and electrophysiology interventions.

Device expands treatment options for high-risk patients with complex aortic conditions, reflecting broader advances in endovascular therapy

Device is intended to treat pain associated with hypertrophic bone growth, a common contributor to lumbar spinal stenosis