The 4 key principles of a smart regulatory strategy for medical devices

Digitization of healthcare and patient data has gained serious traction on a global scale, driven by the increased demand for connectivity. Now, there is an evident shift away from traditional clinical settings for healthcare. Therefore, it has never been timelier to consider a cybersecurity strategy to maintain patient safety and confidentiality.

ASP Health and Planet Innovation have received the Bronze Award in the Testing and Diagnostic Product and Systems category at the 2022 Medical Design Excellent Awards (MDEA) for their innovative, FDA-registered automated sample preparation system.  

Michael Robards recently moderated an insightful panel discussion at BIOMEDevice Silicon Valley on what it’s been like getting in-vitro diagnostic medical devices (IVD) to market over the last few years.

From start-ups to established companies, almost everyone in the life sciences and diagnostics industries is playing with digital health in one form or another. But how do you ensure this investment translates into commercial success for your company?

Planet Innovation co-CEO and co-founder Stuart Elliott described the COVID-19 pandemic as a “wake-up call” for how medical products are sourced, in an interview with ABC Radio.

An RMIT University researcher working with PI on technology that can test patients for bleeding or clotting disorders has been awarded more than $650,000 in NHMRC funding.

Planet Innovation was a standout performer picking up two of the highest honors at this year’s MDEAs for innovation in medical product design and engineering.

In a world first, a baby girl has been born using the specially-designed imaging incubator, Geri, developed and commercialized by Genea and Planet Innovation.

Pharmaceutical giant Merck Serono has signed an exclusive deal securing global marketing and commercialization rights to Genea Biomedx’s range of IVF products including Gavi and Geri, which were designed by Genea with development partner, Planet Innovation.

Tomas Stojanov has been an integral part of an extremely successful network of invitro-fertilisation (IVF) clinics in his role as the CEO of fertility group Genea, but his personal dream is to do more. He wanted to change the world of IVF to benefit his company, his industry and most importantly his patients.

PI Executive Director Eduardo Vom reveals the details to the microfluidic pod that was developed for the Gavi instrument to enable automated IVF vitrification for the first time in the world.

Dr. Ian Macfarlane will share his real-world experience on the ingredients to success for both start-up and established IVD companies at Ausmedtech 2013.