FDA Classifies Banyan Biomarkers’ Brain Trauma Assays as Class II Devices (RAPS.org)
The US Food and Drug Administration (FDA) classified brain trauma assessment tests and endoscopic electrosurgical clip cutting systems as class II devices. Both device classifications were established via the De Novo pathway based on FDA’s review of 2016 and 2017 requests from Ovesco Endoscopy AG and UF startup Banyan Biomarkers, respectively. These in turn allow […]
Colorado Surgeon Implements Exactech’s Cutting-Edge Technology (Post Independent)
Dr. Ferdinand Liotta is the first physician in Colorado to use a new state-of-the-art technology that helps physicians virtually simulate a surgery before even making the first incision. The orthopedic surgeon at Valley View Hospital, who specializes in shoulder surgery, said he came across the new computer-assisted navigation tool before the company had even finished […]
UF Startup AxoGen CEO Karen Zaderej Awarded Entrepreneur of the Year in Health Care (Jacksonville Business Journal)
Karen Zaderej, CEO of Alachua-based AxoGen Inc., a UF startup, took home the prize in the Health Care category. Her company focuses on the development and commercialization of technologies for peripheral nerve regeneration and repair. “I am honored to be named an Entrepreneur Of The Year award winner in Florida,” Zaderej said in a statement. […]
UF Startup Peerfit Ranked in Top 10 Small-Medium Companies for Best Leadership (USA Today)
HubSpot, Google and Facebook top the list of companies with the best leadership teams among large companies, according to compensation, culture and career monitoring website Comparably. UF startup Peerfit ranked in the top 10 of the list of small-medium companies. Leadership teams consist of roughly 10 to 20 executives within a company. According to Comparably […]
Alachua Biotech Firm Speeds Test for Brain Injuries (Gainesville Sun)
(UF startup Banyan Biomarkers recently received FDA approval for its blood test that measures biomarkers that indicate traumatic brain injury. The blood test will streamline diagnoses, cut back on unnecessary CT scans, and should be available in about two years.) Ron Hayes remembers the moment his career in neuroscience took a turn — from being […]
Paracosm’s PX-80 Handheld Lidar Is Fast and Flexible Enough to Be Your Standalone Scanner (Spar3D)
UF startup Paracosm’s PX-80 handheld lidar scanner has come a long since the company introduced it to the market early last year. The company says the device has been in high demand not only in architecture engineering & construction, but also in a number of industries, with users capturing everything from dense Japanese forests to […]
Exactech Combines Computer Technology and Instrumentation for Revision Knee Surgery (BusinessWire)
UF startup Exactech, a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced that two of its leading technologies were used in combination for the first time to support a revision total knee surgery. Bernard Stulberg, MD, at the St. Vincent Charity Medical Center in Cleveland, […]
AxoGen Appoints Karen Zaderej as Chairman of the Board (Biospectrum)
UF startup AxoGen, a global leader in developing and marketing innovative surgical solutions for peripheral nerves, announced that its Board of Directors has elected Karen Zaderej as Chairman of the Board in addition to her current role as President and Chief Executive Officer (CEO), effective immediately. Zaderej succeeds Jamie M. Grooms, who will remain a […]
Sun BioPharma to Begin Dosing Pancreatic Cancer Patients in Clinical Trials (Globe Newswire)
UF startup Sun BioPharma, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, provided a business update and reports financial results for the quarter ended March 31, 2018. The Company’s newest trial, a combination of SBP-101 to be administered with gemcitabine and nab-paclitaxel in previously untreated patients with metastatic […]
Morphogenesis to Begin Clinical Trials on Promising Cancer Therapy (WLRN)
A UF startup based in Tampa has received approval to start clinical trials on a new form of gene therapy to treat cancerous tumors. Morphogenesis, Inc. will begin the trials on six patients with an aggressive form of skin cancer at Moffitt Cancer Center this summer. The therapeutic vaccine is injected into a cancerous tumor […]