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Stem cell therapy is a groundbreaking field in the pharmaceutical industry, offering powerful tools for treating severe diseases such as cancer. The genetic manipulations involved in this process, however, necessitate stringent regulations to ensure sterility and safety. In 2017, the Food and Drug Administration (FDA) took significant steps towards regulating stem cell therapy, marking a pivotal ...
Through the De Novo classification process, the FDA established a new Class II device classification and clarified that UV products intended to reduce microbial load on non-porous, non-critical medical device surfaces (such as hospital beds, wheelchairs, IV poles and other medical devices common in patient rooms and operating rooms) now require FDA authorization before they can ...
Post-surgical infections create a significant healthcare burden on hospitals and healthcare systems costing $10 billion per year in the US. A single MRSA post-surgical infection costs over $160,000 to treat and adds 15 days onto a hospital stay. ...
VR therapy on the palliative care ward Last week, we were on site at the Charité to present our VR system in detail to the employees. We clarified all questions together and talked about joint projects. ...
Utilizing the Q-Submission Program, the company has engaged in ongoing dialogue with the FDA clarifying requirements in an effort to mitigate against timeline risks. ...
Glaukos’iLinkpharmaceutical platform consists of novel single-use drug formulations that are bio-activated by proprietary systems through the delivery of ultraviolet light to the cornea to induce a reaction called corneal cross-linking designed to strengthen, stabilize and reshape the cornea. ...
Health Canada approved the amendment of the phase I study to assess the effect of low and moderate doses of inhaled CBD in healthy cannabinoid users. The collaboration with the CRCHUM will allow Tetra to obtain phase I clinical data on inhaled CBD. OTTAWA, ON, March 8, 2022 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in ...
The publication provides an approachable overview of stem cell biology and clarifies common misconceptions about adipose-derived regenerative cells (ADRCs) including vascular-associated pluripotent stem cells (vaPS cells). ...
The Biomedical Bioinformatics Platform belongs to CD Genomics and has a good reputation for assisting researchers with data analysis challenges, including NGS data processing, analysis, interpretation, and general genomic data analysis, as well as data mining, statistical modeling, data integration, information science, database construction, and management. Recently, the company announced the ...
SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that it has enrolled the first patient into a Phase 2 clinical trial of GLK-302 for the treatment of presbyopia. GLK-302 is the second investigational ...
Approximately 70% of Subjects were Well-Controlled on iDose TR with the Same or Fewer Topical IOP-Lowering Medications at 36 Months vs. Screening Favorable Safety Profile Through 36 Months . SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal ...
SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that it has enrolled the first patient into a Phase 2 clinical trial of GLK-301 for the treatment of signs and symptoms of Dry Eye Disease (DED). ...
Food and Drug Administration (FDA) for the iPRIME™ Viscodelivery System, a sterile, single-use, minimally-invasive device for the delivery of viscoelastic fluid during ophthalmic surgery. ...
RNA Solutions is the platform that offers services on the revolutionizing study of RNA, targeting both coding and non-coding RNAs of different physiological functions. The scientists at CD Genomics are ready to help detect various types of RNA via meticulous and integrative approaches. To further enrich its service types, the company recently announced to add Ribo-Seq to its offerings. ...
“Hyperfine is delivering the future of digital surgery and transforming the care continuum through accessible and intelligent imaging with the first FDA-cleared portable MRI system. Hyperfine’s technology gives healthcare professionals better insight to improve clinical care from the ambulance to the hospital and ultimately to the home. ...
Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (Diffusion or the Company), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, today announced that the Company has obtained clearance of its Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration’s ...
ByCervoMed
The consortium will develop a prototype advanced control strategy that is independent of equipment or control system suppliers and overlay this strategy onto an existing small-scale continuous bioprocessing module operating at CPI. ...
Improved quality of care and significant cost savings using the test to guide adjuvant chemotherapy treatment Analysis based on first results from the independent RxPONDER study which identified the majority of women with one to three positive nodes who receive no benefit from chemotherapy Exact Sciences today announced results from a health economic analysis of the Oncotype DX Breast ...
Intersect ENT®, Inc. (Nasdaq: XENT), a global ear, nose and throat (“ENT”) medical technology leader dedicated to transforming patient care, today announced that the Centers for Medicare and Medicaid Services (CMS) published an average selling price (ASP) for the Company’s SINUVA sinus implant, providing predictability, transparency, and confidence of reimbursement for ...
The British Occupational Hygiene Society, a leading scientific charity and the Chartered Society for Worker Health Protection has issued interim advice on vaccination in the workplace. The British Occupational Hygiene Society, a leading scientific charity and the Chartered Society for Worker Health Protection has issued interim advice on vaccination in the workplace. With the ...