Medtronic’s (NYSE:MDT) Microstream capnography (CO2) and Invos regional oximetry (rSO2) platforms can now be integrated with GE Healthcare’s Carescape. The two companies announced today that they received FDA clearance and CE mark approval for the integration of Medtronic’s Microstream and Invos technologies for perioperative and ICU care on the GE Healthcare Carescape precision monitoring platform. According […]
FDA
Stryker’s spine guidance software wins FDA clearance
Stryker (NYSE:SYK) announced today that its Q Guidance System for advanced surgery planning received FDA 510(k) clearance. Kalamazoo, Michigan–based Stryker designed the Q Guidance system for use with its spine guidance software for advanced planning and intraoperative guidance that enables open or percutaneous computer-assisted surgery. Q Guidance offers multiple tracking options, sophisticated software algorithms and […]
Si-Bone wins FDA clearance for pelvic fixation, fusion tech
Si-Bone announced today that it received FDA 510(k) clearance for its iFuse Bedrock Granite implant system for spinal procedures. Santa Clara, California-based Si-Bone designed the iFuse “Granite” implant to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. According to a news release, FDA clearance follows earlier breakthrough device designation […]
FDA clears Abbott’s next-gen FreeStyle Libre 3 14-day CGM
Abbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation FreeStyle Libre 3 continuous glucose monitor. FDA clearance for the latest iteration of the company’s FreeStyle Libre platform — designed as the smallest and thinnest CGM sensor in the world — covers use by people 4 years of age and older living with diabetes. […]
Abbott imaging catheter recall flagged as Class I by FDA
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The […]
FDA grants IDE for MedAlliance’s sirolimus-eluting balloon
MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon. Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent. Get the full story at our sister site, Drug Delivery Business News.
Device developer SeaStar Medical hires chief medical officer
SeaStar Medical has hired Dr. Kevin Chung as chief medical officer of the medtech developer starting July 1. Denver-based SeaStar is developing a platform therapy focused on hyperinflammation of vital organs. The company’s Selective Cytopheretic Device was designated as a breakthrough device by the FDA earlier this year. SeaStar is set to go public in the […]
inHeart wins FDA clearance for 3D cardiac modeling software
inHeart announced today that it received FDA 510(k) clearance for its inHeart Models software suite for cardiac modeling. France-based inHeart designed its inHeart Models software to enable the 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use. FDA clearance allows for the expansion of the company’s commercial footprint in the U.S. […]
FDA clears RapidAI’s pulmonary embolism triage platform
RapidAI announced today that it received FDA 510(k) clearance for its Rapid PE Triage & Notification product. San Mateo, California-based RapidAI designed its Rapid PE Triage & Notification product for the fast identification and communication of suspected central pulmonary embolism (PE). According to a news release, Rapid PE Triage & Notification works in conjunction with […]
iRhythm stays silent on federal grand jury subpoenas
More than one year after receiving the first of two federal grand jury subpoenas seeking information about its products and communications with the FDA, iRhythm Technologies has said little publicly about the matter. It would have been easy to miss the San Francisco-based cardiac monitor maker’s initial disclosure last summer. iRhythm (Nasdaq:IRTC) was without a […]
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A lot of talk around Dexcom (Nasdaq:DXCM) in the last couple of years has centered around its next-generation G7 continuous glucose monitor. The latest iteration of the company’s CGM platform has already garnered CE mark this year and awaits FDA approval, with some expectations for that to come after the American Diabetes Association’s Scientific Sessions next month. The company also presented […]