Exactech Announces FDA Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System
UF Startup Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System.
Dialectic Therapeutics Announces DT2216 Has Received Orphan Drug Designation From the FDA for the Treatment of T-Cell Lymphoma
UF startup Dialectic Therapeutics, Inc. (Dialectic®), announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DT2216 for the treatment of T-cell lymphoma.
Morphogenesis’ Skin Cancer Vaccine Gets FDA ‘Fast Track’
Tampa company Morphogenesis, a UF startup, has received a “fast track” designation for its skin cancer vaccination from the United States Food and Drug Administration.
UF Anticancer Drug Receives FDA Clearance for Clinical Trials
An anticancer drug developed by researchers from the University of Florida College of Pharmacy has become the first drug of its kind allowed to proceed to clinical trial by the U.S. Food and Drug Administration.
Dialectic Therapeutics Receives FDA Clearance of IND Application for for Its Lead Product Candidate To Treat Cancer
UF startup Dialectic Therapeutics, Inc., a Texas-based biotechnology company focused on creating innovative new technologies to treat cancer, announced that the U.S. Food and Drug Administration (FDA) has concluded that Dialectic may proceed with its clinical investigation for its lead product candidate, DT2216, a unique compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD) technology.
Pear, etectRx To Explore Use of Sensors To Help Patients Stick With Digital Therapeutics
Pear Therapeutics is teaming up with UF Innovate | The Hub startup etectRx in a "first of its kind" collaboration examining the use of digital pill solutions with prescription digital therapeutics (PDTs), the latter company announced. As part of the agreement, whose financial terms were not disclosed, the companies will work on developing up to two central nervous system product candidates combining PDTs and adherence sensors.
Abbott Blood Test To Evaluate Mild Concussions Wins FDA Clearance
Doctors soon will have a new way to evaluate patients with concussions: a rapid blood test made by Abbott Laboratories that has been cleared by the U.S. Food and Drug Administration. It’s an advancement that could eliminate the need for some patients to get costly CT scans and the radiation exposure that accompanies them.
RTI Surgical Receives 510(k) Clearance for Dynamic Active Compression (DAC) Plate
UF startup and UF Innovate | Sid Martin Biotech alum RTI Surgical Holdings, Inc., a global surgical implant company, recently received 510(k) Clearance from... Read More
