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Chinese FDA requiring self inspections for Class II and III medical device...
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) has set a July 15, 2016 deadline for distributors of higher-risk medical devices to submit self-inspection reports. The...
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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...
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Healthcare service providers Envision, AmSurg to merge in $10B deal
(Reuters) – Envision Healthcare Holdings Inc and AmSurg Corp have agreed to an all-stock merger that would create a healthcare service provider with a proforma market value of about $10 billion, the...
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Chinese dev LifeTech wins CE Mark for LAA closure device
Chinese developer LifeTech Scientific said today it won CE Mark approval in the European Union for its LAmbre left atrial appendage closure system, touting it as the 1st Chinese-developed LAA closure...
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Philips launches CarePoint 5.0 resident safety management system
Royal Philips (NYSE:PHG) said yesterday it launched its CarePoint 5.0 resident safety and wander management solution system designed for senior living facilities and communities. The new version of the...
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Elekta inks U.S. brachytherapy distro deal with Kobold Medical.
Elekta (STO:EKTA B) said yesterday it inked a distribution deal with Kobold Medical to distribute its brachytherapy applicators within the U.S. Through the deal, Elekta will market and distribute 4...
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Cytori Therapeutics closes $17m funding round
Cytori Therapeutics (NASDAQ:CYTX) said today it closed a $17.1 million rights offering round, floating 6.7 million units at $2.55 each. Through the rights offering, each of the 6.7 million units...
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BioTime announces new funding round
BioTime yesterday announced a new offering of shares to support the development and commercialization of its regenerative medicine technologies. BioTime and its subsidiaries develop regenerative...
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Spectral Medical touts PMA acceptance for sepsis treatment
Spectral Medical today announced the FDA has reviewed and accepted 1 of 2 pre-clinical modules in its premarket approval application for its Toraymyxin device designed ot remove endotoxins from the...
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Boston Scientific wins UK NICE support for GreenLight laser therapy
Boston Scientific (NYSE:BSX) 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...
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Si-Bone touts updated 510(k) clearance indications, MAC reimbursement wins...
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...
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St. Jude launches Infinity deep brain stim system in the EU
St. Jude Medical (NYSE:STJ) 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...
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Baxter touts high compliance rate with use of Sigma Spectrum infusion systems
Baxter (NYSE:BAX) today touted compliance data from facilities equipped with its Sigma Spectrum Infusion pump system, citing an overall average of 97% drug library compliance during the 1st 30 days of...
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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...
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Hill-Rom launches VisiVest connected airway clearance system
Hill-Rom Holdings (NYSE:HRC) said today it launched the VisiVest System designed for patients in need of airway clearance therapy. The newly launched system combines high-frequency chest-wall...
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EU Council & Parliamentary councils signs off on new med device, IVD regs
The Environment, Public Health and Food Safety Committee of the European Parliament and Council’s Committee of Permanent Representatives voted yesterday to endorse new medical device and in vitro...
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SpineGuard wins FDA nod for PediGuard threaded DSG device.
SpineGuard (EPA:ALSGD) said today it won FDA 510(k) clearance for its PediGuard threaded Dynamic Surgical Guidance device designed for pedicle screw insertion. The PediGuard device is available in...
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MassDevice.com +5 | The top 5 medtech stories for June 16, 2016
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...
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New draft european IVDR text released: Initial analysis
By Stewart Eisenhart & Ronald Boumans, Emergo Group Publication of draft In Vitro Diagnostic Regulations (IVDR) in the European Union, which occurred earlier than anticipated, provides IVD...
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OrthoPediatrics registers $75m IPO
OrthoPediatrics, which says it is the only medical device company exclusively devoted to orthopedic implants for children, this week registered for an initial public offering worth $75 million. Based...
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