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....
View ArticleWearable 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...
View ArticleChinese 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...
View ArticleAccuray 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....
View ArticleFDA 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....
View ArticleNatus 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...
View ArticleObalon 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...
View ArticleEIT 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,...
View ArticleFDA 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....
View ArticlePerkinElmer 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 &...
View ArticleAllergan 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....
View ArticleBrainScope wins FDA nod for Ahead 300 TBI scanner
Brainscope said today 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. Dept. of Defense. The Bethesda,...
View ArticleMassDevice.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...
View ArticleHill-Rom picks up Tridien Medical; inks $1.5B term loan; reportedly deals...
Hill-Rom Holdings (NYSE:HRC) last week released a slew of new announcements, saying it inked a $1.45 billion term loan A facility, acquired med tech firm Tridien Medical and that it’s looking to sell...
View ArticleSt. Jude seeks shareholder approval for Abbott merger
St. Jude Medical (NYSE:STJ) is reaching out to shareholders to approve its proposed $25 billion merger with Abbott (NYSE:ABT), according to an SEC filing posted today. The Memphis, Tenn.-based company...
View ArticleCalifornia tech councils OCTANe, OC Tech Alliance to merge
Two Southern California tech council groups are set to merge, according to a new report from the Orange County Business Journal. Aliso Viejo, Calif.’s group OCTANe will merge with the Mission Viejo,...
View ArticleNovaBone wins CE Mark for collagen-based dental wound dressings
Bio-active synthetic bone graft company NovaBone said today it won CE Mark approval in the European Union for its NovaTape and NovaPlug dental wound dressings. The Jacksonville, Fla.-based company said...
View ArticleUS issues final rules for clinical trial information reporting
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: A final rule from the US Department of Health and Human Services (HHS) expands clinical trial reporting requirements to the...
View ArticleGore wins Medicare add-on status for Excluder stent graft
W.L. Gore & Assoc. said today that it won new technology status from the U.S. Centers for Medicare & Medicaid Services for its Gore Excluder iliac branch endoprosthesis. Set to go into effect...
View ArticleBoston Scientific to pay $210m for EndoChoice
Boston Scientific (NYSE:BSX) said today that it agreed to pay $210 million for EndoChoice (NYSE:GI) and its line of devices for treating gastrointestinal disease. The $8-per-share offer is slated to...
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