Reported sales and earnings from the publicly traded cardiovascular device companies in 2018 were generally strong, led by transcatheter aortic valve replacement devices, but some sectors of the industry, especially ventricular assist devices and peripheral drug-coated balloons, face significant challenges. Here's a recap of results from the cardio device companies that have reported so far, with a focus on Medtronic, Edwards, and Abbott.
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[Editor's note:Look out for upcoming recaps of earnings reports in the IVD and orthopedics sectors.]
Medtronic PLC continues to rely heavily on the success of its CoreValve transcatheter aortic valve (TAVR) to drive revenue growth. For the third quarter of fiscal 2019, ended Jan....
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The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.
NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.
Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.
“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
