Approvals of high-risk devices drop as de novos take off
Changes at the FDA have altered the device approval landscape, with the de novo route now the most popular.
The fourth quarter sell-off hurt big medtech less than big pharma
Some medtech stocks did decline in 2018, but many more increased in value.
Ascensia banks on accuracy and collaboration to face down new tech
Forming partnerships with a number of players in diabetes technology is the key to growth, according to Ascensia Diabetes Care.
Typezero takeover puts Dexcom closer to an artificial pancreas
Dexcom can capitalise on its new algorithm technology, but is now enmeshed in a tangled web of partnerships.
Novo makes another early-stage diabetes bet with Ziylo buy
The Danish company’s latest deal covers glucose-sensitive insulin, which could avoid hypoglycaemia in type 2 diabetes patients.
Despite the FDA’s best efforts, device approvals crash
Regulatory intervention having limited impact on fostering innovation.
Fireworks among the small and mid-cap device makers
Smaller medtechs saw impressive share price growth in 2018, but not quite as good as the year before.
Beta Bionics brings machine learning to insulin delivery
Can a device control a patient’s blood sugar based on bodyweight alone?
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