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MassDevice.com +5 | The top 5 medtech stories for September 23, 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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Medical Murray adds clean room space in two facilities
Medical Murray, a device development and contract manufacturing company with ISO 13485 certification and FDA registration, has expanded clean room capabilities in their Illinois manufacturing facility...
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CytoSorbents enters Iran
CytoSorbents said today it is entering the Iranian market with its CytoSorb adsorber through an exclusive distribution agreement with Armaghan Salamat Kish Group. The CytoSorb adsorber is designed to...
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Medtronic opens diabetes HQ in Minn
Medtronic (NYSE:MDT) said this month it opened a new headquarters for its non-intensive diabetes therapy business unit in Plymouth, Minn. The newly opened facility will act as the global headquarters...
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FDA relabels RebiScan Pediatric Vision Scanner as Class II device
The FDA today said it reclassified RebiScan’s handheld Pediatric Vision Scanner device as a class II device. RebiScan’s flagship Pediatric Vision Scanner won FDA de novo clearance in June, with...
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Spineology makes Musculoskeletal Transplant Foundation its sole allograft...
Spinal tech developer Spineology said today it expanded its relationship with the Muscoloskeletal Transplant Foundation, making it the sole tissue provider for its allograft product lines. The expanded...
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Surgical Theater, NordicNeuroLab launch VR diffusion tensor imaging
Surgical Theater said today it inked a partnership deal with NordicNeuroLab to integrate its nordicBrainEx diffusion tensor imaging into Surgical Theater’s Precision VR medical visualization platform....
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Wearable heart monitor maker iRhythm registers for $86m IPO
iRhythm Technologies last week registered for an initial public offering worth $86 million it plans to use to expand the commercial and clinical footprint of its Zio wearable cardiac monitor. San...
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Chinese FDA adds to medical device submission document requirements
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: Chinese market authorization applicants will have to submit hard and soft copies of their registration applications to regulators, plus...
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Accuray touts 5-year CyberKnife data in prostate cancer trial
Accuray (NSDQ:ARAY) today released 5-year data from a study of its CyberKnife stereotactic body radiotherapy device for treating prostate cancer, touting a 97% rate of freedom from cancer at 5 years....
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FDA clears Medtronic’s StealthStation DBS lead placement software
Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for its StealthStation software, which is designed to help plan the placement of the leads used for deep-brain stimulation therapy....
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Natus puts up $145m for GN Otometrics, cuts guidance on shipment hold
Shares in Natus Medical (NSDQ:BABY), which said today that it agreed to put up $145 million for GN Store Nord‘s (CPH:GN) otometrics hearing and balance diagnostics business, plunged today after Natus...
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Obalon Therapeutics sets terms for $75m IPO
Obalon Therapeutics today set the terms for its forthcoming initial public offering, saying it plans to float 5 million shares at $14 to $16 apiece. At the midpoint, the weight loss device maker’s IPO...
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EIT lands investment from SHS for 3D-printed ortho implant
German private equity player SHS said it invested an undisclosed amount in Emerging Implant Technologies and its 3D-printed orthopedic implants. EIT develops 3D-printed orthopedic devices and implants,...
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FDA OKs Regentis Biomaterials trial for GelrinC knee cartilage treatment
Regentis Biomaterials said today it won an investigational device exemption from the FDA for a pivotal trial of its GelrinC hydrogel-based resorbable treatment for focal cartilage defects in the knee....
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PerkinElmer looks to spin out diagnostics biz
PerkinElmer said today that it’s planning to spin out its reproductive health-focused diagnostics business, effective Oct. 3. The new stand-alone will be headed by newly-assigned senior VP &...
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Allergan wins FDA nod for Natrelle Inspira breast implants
Allergan (NYSE: AGN) said last week that it won FDA pre-market approval for its Natrelle Inspira cohesive breast implants for women undergoing breast reconstruction, augmentation or revision surgery....
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BrainScope wins FDA nod for Ahead 300 TBI scanner
Brainscope said today that it won FDA 510(k) clearance for its next-gen Ahead 300 traumatic brain injury assessment device, developed through a partnership with the U.S. Defense Dept. The Bethesda,...
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MassDevice.com +5 | The top 5 medtech stories for September 26, 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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Hill-Rom picks up Tridien Medical, inks $1.5B term loan, reportedly deals...
Update: Added more information and comments from PeriGen. Hill-Rom (NYSE:HRC) said it paid an undisclosed amount for patient positioning device maker Tridien Medical and took out a $1.45 billion loan,...
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