Life Spine announced that it won FDA 510(k) clearance for its steerable Plateau Ti system for surface treatment for potential bone growth. Plateau Ti is a titanium interbody system designed to provide an optimal environment for bone growth in both transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF). It is used to […]
FDA
GE Healthcare recalls nearly 3,600 anesthesia systems
GE Healthcare (NYSE:GE) is recalling certain Carestation anesthesia systems in the U.S. due to a problem that could halt patient ventilation, according to the FDA. FDA labeled the recall as Class I, the most serious type of medical device recall. The Carestation 620/650/650c A1 models may have a loose interior cable connection that could cause […]
Invo Bioscience to study extended use of fertility system
Invo Bioscience (OTCQB:IVOB) has received FDA approval to begin a clinical trial of its modified InvoCell system. The trial will measure InvoCell’s effectiveness in achieving fertilization, implantation, embryo development, clinical pregnancy and live birth after 5 days of continuous vaginal incubation, according to the Sarasota, Fla.-based company. The device is currently cleared for 3-day use. The […]
GE Healthcare respiratory analyzer recall is Class I
The FDA has designated a recall of certain GE Healthcare (NYSE:GE) respiratory analyzers used in patient monitoring as Class I, the most serious type of recall. GE Healthcare began the recall of Carescape respiratory modules and Airway Gas Option NCAiO units in September 2019 because faulty oxygen sensors may cause them to display incorrect patient oxygen […]
Abbott wins FDA breakthrough nod for ventricular assist system
Abbott (NYSE:ABT) announced today that it won FDA breakthrough device designation for its in-development fully implantable left ventricular assist system (Filvas). According to a news release, left ventricular assist devices are implanted into the body and powered using an external battery pack or charging port. Abbott’s fully implantable device would require no external components, offering more […]
FDA, FTC want to encourage competition in biologics market
The FDA and U.S. Federal Trade Commission (FTC) announced today that they signed a joint statement to encourage collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. The two agencies said the statement sets out to address false or misleading promotion about biosimilars within the […]
Hahn outlines goals for FDA
New FDA commissioner Stephen Hahn outlined his agenda for the agency in an all-hands email yesterday. A radiation oncologist, Hahn took over as FDA chief in December after a stint as chief medical officer at Houston’s M.D. Anderson Cancer Center. In the email, Hahn focused on three areas: better acquisition, integration and use of data; patient- and […]
Dräger Medical cited in FDA warning letter
This article has been updated with comments from Dräger Medical. The FDA has issued a warning letter to Dräger Medical following an inspection of its Andover, Mass., facility in August and September 2019. The agency faulted the patient-monitoring company for failing to file for 510(k) clearance of its Infinity acute care system (IACS) M540 although it made […]
Eko AFib and heart murmur algorithms win FDA clearance
Eko announced today that it won FDA clearance for its suite of algorithms that combine with the company’s digital stethoscopes to screen for heart conditions during routine physical exams. The San Francisco-based company develops an artificial intelligence-powered, cloud-based software application designed to analyze electrocardiogram (ECG) and heart sound/phonocardiogram (PCG) data, using signal processing and convolutional […]
King Systems recalls some video laryngoscope video adapters
King Systems announced that it initiated a voluntary recall of 171 units of its King Vision video laryngoscope adapter size 1/2 because of an issue where the device exhibits a reversed image. Any product that displays a reversed image could potentially cause difficulty navigating during intubation and/or a delay in intubation, according to an FDA […]
Strata Skin Sciences wins FDA clearance for excimer laser platform
Strata Skin Sciences (NSDQ:SSKN) announced that it won FDA 510(k) clearance for its Xtrac Momentum excimer laser system for treating a number of skin diseases. The Xtrac laser is designed to deliver a highly targeted therapeutic beam of UVB light in the treatment of psoriasis, vitiligo, eczema, atopic dermatitis and leukoderma. It is made in three […]