Automated insulin delivery technology developer Tandem Diabetes Care (NSDQ:TNDM) announced new appointments in three executive leadership positions. San Diego-based Tandem named Rick Carpenter as CTO, Libba Sapitsky as SVP of Customer Care and Rizwan Pervez as SVP of Quality and Regulatory. According to a news release, Carpenter, a veteran of more than 30 years in […]
FDA grants breakthrough nod to Zetagen’s metastatic bone cancer treatment
Zetagen Therapeutics announced today that it received FDA breakthrough device designation for its ZetaMet cancer treatment technology. Syracuse, New York-based Zetagen designed its ZetaMet (previously known as ZetaFuse) as a synthetic, small-molecule, inductive biologic technology for targeting and resolving metastatic bone lesions while inhibiting future tumor growth and regenerating bone. According to a news release, […]
Bigfoot Biomedical touts cloud-based program for managing diabetes
Bigfoot Biomedical officials think their Bigfoot Unity diabetes management program and Bigfoot Clinic Hub could up the game in the space. Milpitas, California-based Bigfoot designed the Bigfoot Unity platform to allow healthcare professionals (HCPs) to review patient data. The information comes from the patient’s prescribed Bigfoot Unity system, integrating with Abbott’s FreeStyle Libre 2 continuous […]
Visus Therapeutics touts data from trial of presbyopia treatment
Visus Therapeutics announced today that three novel presbyopia treatments achieved their improvement endpoints in a Phase 2 study. Seattle-based Visus’ Vivid Phase 2 study observed all three of the included investigational candidates achieve the endpoint of three lines of improvement in binocular near visual activity without losing one line of distance vision with a minimum […]
FDA authorizes expansion of Fractyl’s pivotal clinical trial for diabetes reversal tech
Fractyl Health announced today that the FDA gave authorization to expand the Revitalize-1 pivotal clinical study of its Revita DMR system. Lexington, Massachusetts-based Fractyl Health (formerly Fractyl Laboratories) can now increase the sample size of the Revitalize-1 trial (formerly Revita-T2Di trial) from 288 to 420. In September, Fractyl activated the 10th clinical site in the […]
AMF Medical wins breakthrough nod for insulin management system
AMF Medical announced today that it received FDA breakthrough device designation for its Sigi insulin management system. Ecublens, Switzerland-based AMF Medical’s Sigi (for diabetes mellitus treatment) can be programmed to deliver basal and bolus insulin at both set and variable rates. Sigi, an alternate controller-enabled pump, can receive, execute and confirm dosing commands through interactions […]
Medtronic plans to bring next-gen diabetes tech to FDA this fiscal year, no spinoff planned
Medtronic (NYSE:MDT) confirmed that it anticipates major regulatory steps for its next-generation insulin pump and sensor during this fiscal year. Medtronic’s fiscal years wrap up at the end of April. Speaking on the company’s second-quarter earnings call, Chair & CEO Geoff Martha said Medtronic expects its MiniMed 780G insulin pump system with the Guardian 4 […]
BioMarin wins FDA approval for injection to increase growth in children with dwarfism
BioMarin Pharmaceutical (NSDQ:BMRN) announced today that the FDA granted accelerated approval for its Voxzogo injection. San Rafael, California-based BioMarin’s Voxzogo (vosoritide) injection has an indication to increase linear growth in pediatric patients with achondroplasia (a form of dwarfism) five years of age and older with open epiphysis (growth plates). Continued approval may be contingent upon […]
Better Therapeutics completes enrollment in type 2 diabetes study
Better Therapeutics (NSDQ:BTTX) announced that it completed patient enrollment in a study of its digital therapeutic in treating diabetes. San Francisco-based Better Therapeutics’ BT-001 prescription digital therapeutic delivers a novel cognitive-behavioral therapy to patients with uncontrolled type 2 diabetes. According to a news release, the trial for BT-001 exceeded its enrollment target, bringing in 662 […]
Pasithea launches in-home ketamine infusion platform in U.S.
Pasithea Therapeutics (NSDQ:KTTA) announced that it commenced clinical operations with its in-home intravenous ketamine therapy. Miami Beach, Florida-based Pasithea’s wholly-owned subsidiary, Pasithea Clinics, offers in-home IV ketamine therapy to patients suffering from treatment-resistant mental health issues. The company will offer the treatment initially in New York City, Los Angeles, San Diego and San Francisco, with […]
