Alpha Tau Receives Medical Device Single Audit Program (MDSAP) Certification

Core Insights - Alpha Tau Medical Ltd. has achieved MDSAP certification for its manufacturing facility in Jerusalem, enhancing its commitment to quality and regulatory compliance while facilitating the global expansion of its alpha-radiation cancer therapy, Alpha DaRT [1][2][3] Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and potential commercialization of Alpha DaRT for treating solid tumors [4] - The Alpha DaRT technology was developed by professors from Tel Aviv University, aiming to deliver potent alpha-irradiation directly to solid tumors while minimizing damage to surrounding healthy tissue [5] Regulatory and Market Implications - MDSAP certification allows Alpha Tau to be audited once for compliance with ISO 13485 and the standards of five different markets, potentially speeding up the commercialization process in these regions [2] - The CEO of Alpha Tau emphasized that this milestone will help expand manufacturing capabilities and expedite marketing approvals across multiple geographies, aiming to bring a transformative product to market for solid tumor treatment [3]