Thinklabs Announces Medical Device Single Audit Program (MDSAP) Certification and TGA Approval in Australia

Thinklabs One
2021-03-12 23:06 3943

Thinklabs is opening business to Australian territories, inclusive of hospitals, private practices, and medical facilities.

CANBERRA, Australia, March 9, 2021 /PRNewswire/ -- Thinklabs, manufacturer of Thinklabs One, the smallest, most powerful electronic stethoscope in the world, today announced they have obtained Medical Device Single Audit Program (MDSAP) certification at their Colorado, USA production facility. Following this, Thinklabs One has received approval from the Therapeutic Goods Administration of Australia (TGA) in Australia.

This compliance enables Thinklabs to conduct business in the Australian market, where they will begin to distribute the Thinklabs One digital stethoscope across Australian territories inclusive of hospitals, private practices, and medical facilities. In particular, Thinklabs One will be available for Covid-19 infection control and the growing telemedicine market.

The MDSAP allows for the single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions. The TGA utilizes MDSAP to ensure medical devices meet conformity assessment procedures and market authorisation requirements.1 Thinklabs One is manufactured in-house in Colorado, USA, ensuring each stethoscope is produced and delivered with care and meets MDSAP requirements.

Thinklabs One is the only stethoscope that allows Safe Distance Auscultation™, enabling doctors to listen to patients' hearts and lungs from a safe distance, a technological advancement that has become increasingly important amidst COVID-19. Currently in use at prestigious medical facilities, including Johns Hopkins, Mount Sinai, and Harvard, the Thinklabs One features more than 100X amplification, compared with a conventional acoustic stethoscope.

"We are excited to bring the Thinklabs One to Australia," says Clive Smith, CEO and founder of Thinklabs. "Working to improve the detection and diagnosis of disease and save patients' lives has always been our priority, and we also want to ensure all doctors and nurses on the frontlines of the pandemic are protected, especially with the rise of the COVID pandemic that carries increased risk with close personal contact. We hope the Thinklabs One can serve as a tool for hospitals and medical facilities to help stop the spread of infectious diseases."

As a leader in telemedicine, Thinklabs is responding to the rapid expansion of telemedicine in Australia and worked with Visionflex on the TGA approval.

"We are pleased to be able to provide the Thinklabs One digital stethoscopes to Australia's telemedicine providers," says Mike Harman, CEO of Visionflex. "Partners like Thinklabs will enable us to cover our country's vast geography, as well as to provide better access to urban residents."

About Thinklabs
Thinklabs was founded in 1991 by Clive Smith, an electrical engineering graduate of Caltech. In the mid 90's, Smith read a paper in the journal Circulation, indicating that stethoscope acoustics had essentially not improved since Rene Laennec invented the stethoscope in 1816. Contemporary physicians confirmed that even top-of-the-line conventional stethoscopes did a poor job of amplifying heart and lung sounds, so Smith went to work to reinvent the vital medical tool.

After years of research, Smith found that he could detect the vibration of a stethoscope diaphragm using a high-intensity electric field - almost 1 million Volts per meter. The result: the Electromagnetic Diaphragm that's key to the audio quality of every Thinklabs digital stethoscope. The Thinklabs One marks a paradigm shift in stethoscope design - a bold move to eliminate the hollow tube styling that predates the American Civil War. The Thinklabs One has since been used as a reference in more than 300 peer-reviewed academic journal papers authored by researchers around the world.

About Visionflex
Visionflex manufactures exceptional medical devices that help doctors, nurses, specialists, and health workers connect via telehealth. Our products include the ProEX Telehealth Hub – a clinical desktop device; and a ruggedised tablet version, the ProEX Mobile. Both units are HIPAA ready, secure, Class 1 Medical devices with CE, FDA and TGA approvals.

The ProEX Telehealth Hub and ProEX Mobile support a comprehensive range of Visionflex cameras, probes, and general exam peripherals, connected to a single hub for viewing, archiving, sharing over telehealth, or even synchronising to medical health record software. All applications are controlled by an intuitive touch-screen interface. Because the ProEX system brings specialist healthcare to the point of need, it is particularly well suited to locations and settings where access can be problematic including rural and isolated communities; retirement and aged care facilities; remote oil, gas, and mining sites; field-health clinics; military and defence; and correctional centres.

Visionflex has had fantastic success with deployments in rural and remote locations, and all over Australia and around the world. In addition to selling our products directly to hospitals, GPs, and specialists, in Australia we also partner with Telstra Health, the Royal Flying Doctor Service, the Australian Antarctic Division, NSW Health, QLD Health, and the NSW Justice Health and Forensic Mental Health Network.

Media Contact
Matt Jaffe


Source: Thinklabs One