Voximetry has received a Medical Device Single Audit Program (MDSAP) Certificate, bringing the company one step closer to market clearance for clinical use of its Torch Dose Assessment software in Canada and Australia, the company announced today.
“Access to new markets is key to Voximetry’s mission of making personalized care available to every patient and care provider,” Voximetry CEO Sue Wallace said in a statement. “Securing MDSAP certification is an important milestone in successfully navigating the commercial growth phase.”
According to the U.S. Food & Drug Administration, a Medical Device Single Audit Program allows an MDSAP-recognized auditing irganization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
Voximetry also announced that it is poised for a CE mark clearance for European commercialization in early 2025.
As previously reported, the company creates technology to enable personalized treatments for late-stage cancer patients.