Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Si-Bone touts updated 510(k) clearance indications, MAC reimbursement wins for iFuse
Si-Bone said this week it won updated 510(k) clearance indications for its iFuse implant system and reimbursement coverage for its minimally invasive surgery sacroiliac joint fusion systems through Medicare Administrative Contractor FCSO.
Si-Bone said the FDA modified the indication statement for its iFuse sacroiliac joint fusion system to include that clinical studies have demonstrated that treatment with the system can improve pain, patient function and quality of life. Read more
4. St. Jude launches Infinity deep brain stim system in the EU
St. Jude Medical today announced the European launch of its Infinity deep brain stimulation system and direction DBS lead, designed to support treatments for movement disorders.
The Infinity DBS system won CE Mark approval in the European Union last September. Read more
3. Biotronik launches its smallest MR-conditional pacing leads in US
Biotronik said today it launched its Solia S ProMRI 5.6 Fr magnetic resonance imaging conditional pacing leads in the U.S., touting them as the smallest available on the market.
The newly launched leads, available in 45, 53 and 60 centimeter lengths, were approved last week based on data collected from the pre-market study phase of its 1,758-patient Siello clinical study. Read more
2. Sleep disorder device maker Oventus opens $12m down under IPO
Sleep disorder device maker Oventus said today it launched a fully underwritten initial public offering in Australia, looking to bring in $8.8 million (AUD $12 million).
The Australian device maker is looking to float 24 million shares, which are slated to be listed on the Australian Securities Exchange at 37¢ (AUD 50¢) each, the company said. Read more
1. Boston Scientific wins UK NICE support for GreenLight laser therapy
Boston Scientific said Tuesday that the U.K.’s National Institute for Health and Care Excellence now provides guidance supporting the use of its GreenLight XPS laser therapy system used to treat prostatic enlargement in patients with benign prostatic hyperplasia.
NICE, which provides evidence-based guidance and standards to the U.K.’s National Health Service, said that adoption of the GreenLight XPS system to treat non high-risk patients with BPH can “significantly reduce costs for the NHS,” Marlborough, Mass.-based Boston Scientific said. Read more
The post MassDevice.com +5 | The top 5 medtech stories for June 16, 2016 appeared first on MassDevice.
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