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ACell wins 510(k) for modified MicroMatrix
ACell said today it won additional FDA 510(k) clearance for its MicroMatrix device allowing the use of the device in conjunction with Cytal wound matrix or Cytal burn matrix devices. The MicroMatrix is...
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Intersect ENT wins expanded FDA approval for Propel Mini
Intersect ENT (NSDQ:XENT) said today it won FDA premarket approval for an expanded indication for its Propel mini steroid releasing sinus implant designed to treat patients undergoing frontal sinus...
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Amniox Medical touts foot ulcer study data
Amniox Medical today released results from a retrospective study of its Neox wound allograft in treating chronic diabetic foot ulcers touting an 87% rate of healing in patients treated with the...
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Xeltis wins FDA nod for bioresorbable pulmonary valve
Xeltis said yesterday that the FDA designated the bioresorbable replacement pulmonary valve it’s developing as a humanitarian use device, granted for device designed to treat rare diseases. The Swiss...
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Capsugel said to explore sale, IPO
Capsugel‘s private equity owner is said to be exploring a sale or initial public offering for the Pfizer (NYSE:PFE) spinout. A deal could value Capsugel, which makes hard capsules and drug delivery...
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Frazier Healthcare raises $525m fund
Private equity shop Frazier Healthcare Partners said yesterday that it raised a $525 million fund to invest in small healthcare companies. The Seattle-based company, which has more than $2 billion in...
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Have a problem? Contact the new ombudsman in the office of regulatory affairs
By: Melinda K. Plaisier Whether we are inspecting your facilities, sampling your products, or conducting investigations, the primary goal of FDA’s Office of Regulatory Affairs (ORA) is to protect the...
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Survey: Medical sales reps like the money, not their bosses
Although medical sales reps report that relationships with patients and providers are the things they like best about their jobs, those who say they’re least satisfied with their jobs are also the ones...
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InVivo raises $32m, enrolls 7th patient in Inspire study
InVivo Therapeutics (NSDQ:NVIV) said today that it cleared $32.2 million from a stock offering after an over-allotment added another 560,000 shares, and said yesterday it enrolled a 7th patient in its...
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What do medical sales reps like most about their jobs?
Money and satisfaction are highly correlated Although medical sales reps report that relationships with patients and providers are the things they like best about their jobs, those who say they’re...
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Sanuwave trial misses efficacy endpoint but shows superiority at 24 weeks
Sanuwave Health (OTC:SNWV) today released 24-week data from the pivotal trial of its dermaPace, saying it missed its 12-week primary efficacy endpoint but returned a greater reduction in wound size and...
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Gore launches new type of study for Synecor hernia biomaterial
W.L. Gore & Associates said today it is launching a clinical quality improvement project to study its Synecor biomaterial designed for open, laparoscopic and robotic single-stage hernia repairs....
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Baxter wins expanded EU indication for Hemopatch
Baxter (NYSE:BAX) said today it won CE Mark approval in the European Union for an expanded indication for its ready-to-use surgical Hemopatch. The Deerfield, Ill.-based company’s Hemopatch is now...
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Carestream seeks FDA nod for OnSight 3D cone-beam extremities CT imager
Carestream Health said today it filed a 510(k) application with the FDA seeking clearance for its OnSight 3D Extremity System cone-beam based extremity CT imaging device. The Rochester, N.Y.-based...
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MassDevice.com +5 | The top 5 medtech stories for March 24, 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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LumiThera wins Health Canada nod for photobiomodulation trial
LumiThera said today it won Health Canada approval for its Lightsite clinical trial examining the effect of its non-invasive photobiomodulation treatment in patients with age-related macular...
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Xtant, Vivex ink distribution deal for OsteoVive allograft
Xtant Medical said today it inked a distribution deal with Vivex Biomedical to distribute its OsteoVive cellular bone allograft. The new agreement will allow Xtant to enter the cellular bone graft...
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TransEnterix pushes Surgibot decision date back
TransEnterix (NYSE:TRXC) yesterday said the FDA isn’t finished reviewing the 510(k) application for its SurgiBot robot-assisted surgery device, meaning the decision it had expected to come during the...
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Exploring better options for ACL repairs
by Lisa Fratt An anterior cruciate ligament (ACL) tear can be a devastating sports injury. Every year, 400,000 people, many of them teen and young adult athletes, sustain ACL injuries or tears. Martha...
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Goldman Sachs gets in on Chinese cardiac valve maker Venus Medtech
Chinese replacement heart valve maker Venus Medtech said today that it won a $37 million commitment from Goldman Sachs (NYSE:GS). Hangzhou-based Venus said it’s also won backing from Qiming Venture...
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