ThinkLabs One, a small but powerful electronic stethoscope, recently earned approval from the Therapeutic Goods Administration of Australia (TGA). Visionflex, an Australian company dedicated to increasing healthcare access in remote and isolated locations through technology, will distribute the digital stethoscope to hospitals, private practices, and other healthcare facilities.
We covered ThinkLabs One in August 2020, documenting the protection from COVID-19 that a wireless stethoscope gives both providers and patients. The stethoscope fits in the palm of a hand; when placed on a patient’s chest, a healthcare worker can use a Bluetooth speaker or headphones to listen to the heart and lungs from across the room, outside the room, or while wearing a full suit of PPE.
The maker of the stethoscope, ThinkLabs, recently obtained Medical Device Single Audit Program (MDSAP) certification for their Colorado manufacturing facility where each stethoscope is made. The MDSAP program provides auditing and monitoring of medical devices built in the US to ensure they meet international safety and oversight requirements.
The MDSAP certification gave ThinkLabs eligibility for TGA approval of ThinkLabs One, opening the door to the Australian market. The certification may also open the door to many more global markets for ThinkLabs in the near future..
Risk mediation for COVID-19 remains the most prominent application for ThinkLabs One in Australia. Widely in use in the United States at such notable medical institutions as Johns Hopkins, Mount Sinai, and Harvard, the device was instrumental in protecting physicians, nurses, and other caregivers during the 2014 Ebola outbreak.