The FDA has chosen not to regulate lab-developed tests like the ones at the center of the Theranos trial.
Tobacco giant Philip Morris has acquired British company Vectura, which make puffers and nebulisers that help people with lung disease to breathe.
How a veterinarian and a law professor joined a multidisciplinary team to help produce a made-in-Saskatchewan emergency-use ventilator during the COVID-19 pandemic.
Drawing thoughtfully on the Powerhouse Museum’s collection, this exhibition lovingly exposes the humanity behind biomedical technology.
A series of interviews with life-sciences executives finds them desperate to bring Zoom meetings to an end.
A few simple pointers can help you spot a quality mask from a dud.
During a pandemic, what would MacGyver do? He’d cobble together masks and ventilators from the things around him. Now health-care workers are doing the same. But there are risks.
Designers, engineers, makers and doctors worldwide have used 3D printing to produce products such as face shields, face masks, ventilator components, hands-free door openers and nasal swabs.
In under 10 days, engineers from UCL and Mercedes F1 reverse-engineered a product, produced a new design, tested it, got regulatory approval and started production.
It’s not as simple as churning out more products, though that’s a good starting point.
How an implant is designed, tested, regulated and discussed with patients tends to disadvantage women. It’s time that changed.
Health insurance costs are rising and the price of prostheses such as hip replacements are partly to blame. But there is a way to rein in costs – and give patients more choice and better devices.
The proposed Australian ban of some types of breast implants is too little, too late. It also reveals regulatory failures that need to be fixed if Australian consumers are to be protected.
Every year, thousands of medical devices and drugs are recalled in the US. But the decision to recall a flawed product is often left up to the manufacturer.
Unlike condoms, which need to be used every time with sex, or the pill, which must be taken every day, LARC doesn’t require any action after placement in the body and is immediately reversible.
Who should be legally responsible when 3D printed devices fail? Proposed changes to the Therapeutic Goods Administration’s regulatory framework have the potential to settle that question.
Australia’s Therapeutic Goods Administration must learn to deal with software rather than simply bits of metal and plastic.
Pacemakers are Internet of Things devices for the human body, but they’re still not particularly secure.
One day doctors could instantly diagnose your illness with a handheld device.
Regulatory bodies approved some medical devices to treat pelvic organ prolapse and urinary incontinence before having data to prove their safety and efficacy.