The product, heavily marketed on social media, is one of more than 28,000 medical devices the regulator considers so low-risk they barely warrant scrutiny. Share A A AAn investigation into medical devices reveals alarming flaws in both the machines we put in our bodies and the system that oversees them. The aligners had the Therapeutic Goods Administration’s (TGA) tick of approval required for all medical devices sold here. In fact, an investigation by this masthead reveals a computer is automatically approving these so-called “Class I” medical devices. “The existence of adverse event reports does not, on its own, establish that a product is unsafe or ineffective,” Byte’s parent company, Dentsply Sirona, said.