MedTech News

Inspira™ Technologies Announces FDA Listing and Market Readiness of New Product
RA’ANANA, Israel, Aug. 22, 2024 /PRNewswire/ — Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (“Inspira” or the “Company”), a leader in life-support technology innovation, today announces the U.S. Food and Drug Administration (“FDA”) listing of its medical cart (INSPIRA™ CART) which has been custom designed for use with the INSPIRA™ ART100 system.

Two New FDA-Clearances for Sibel Health Enables Compatibility of Advanced Wearable Sensors to 3rd Party Software Solutions
CHICAGO, Aug. 22, 2024 /PRNewswire/ — Sibel Health announces two additional FDA-clearances enabling its advanced wearable sensors to operate with compatible third party software applications. In order to democratize vital signs globally, Sibel Health is committed to enabling widespread access to its advanced wearable sensors.

hepatoSIGHT liver disease tool receives MHRA clearance
Predictive Health Intelligence’s flagship product, hepatoSIGHT, a case-finding search engine that enables clinicians to identify people potentially at risk for liver disease, has now received Class I clearance from the Medicines and Healthcare products Regulatory Agency (MHRA).

AtriCure wins expanded CE mark for left atrial appendage device
AtriCure (Nasdaq: ATRC)+
announced today that it received an expanded indication for its AtriClip devices in Europe.

Cytovale Expands FDA-Cleared Sepsis Detection Technology to the Froedtert & the Medical College of Wisconsin Health Network
SAN FRANCISCO and MILWAUKEE, Aug. 21, 2024 /PRNewswire/ — Cytovale®, a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, today announced that the Froedtert & the Medical College of Wisconsin health network is now screening patients with IntelliSep® in a pilot at its flagship hospital, Froedtert Hospital in Milwaukee.

SoClean wins FDA de novo nod for CPAP, ventilation hose cleaner
SoClean this week announced it was granted FDA de novo clearance for its at-home CPAP mask and ventilation hose cleaner SoClean 3+.

Si-Bone wins FDA clearance, breakthrough nod for pelvic fixation implant
Si-Bone this week announced it received FDA 510(k) clearance and FDA breakthrough device designation for its iFuse Torq TNT Implant System.

FDA approves label expansion for Abbott HeartMate 3 LVAD to remove aspirin from treatment regimen
Abbott (NYSE: ABT)+
announced today that the FDA approved a label change for its HeartMate 3 left ventricular assist device (LVAD).