FDA approves a Delphinus Medical Technologies PMA for its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjunct to digital mammog...
The FDA Vaccines and Related Biological Products Advisory Committee will consider 10/14 Modernas request for an EUA for a Covid vaccine booster jab.
Some 26 healthcare organizations led by Public Citizen say they oppose the potential nomination of BIO CEO Michelle McMurry-Heath to be FDA commission...
FDA issues a safety alert about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip syringes.
FDA issues an online Frequently Asked Questions document on the shortage of sodium citrate blood specimen collection tubes used in coagulation testing...
FDA clears a Life Spine 510(k) for the ProLift micro Expandable Spacer System for endoscopic transforaminal and posterior lumbar interbody fusion proc...
FDA issues a Warning Letter to contract testing laboratory Missouri Analytical Laboratories after a May inspection cited significant GMP violations fo...
FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 181 blood test as an aid in diagnosing Alzheimers Disease.