Entries by CAPTIS

Egypt fast-track medical device registration pathway speeds up market access timeframes

By Stewart Eisenhart, Emergo Group A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com […]

Allele, SCM Lifescience sign joint research and development agreement to develop iPSC-based diabetes treatment

iPSCs can be derived from adult human tissue cells yet share the developmental potentials of embryonic stem cells. Currently Japan has 6 ongoing clinical trials utilizing this technology, The post Allele, SCM Lifescience sign joint research and development agreement to develop iPSC-based diabetes treatment appeared first on Pharmaceutical Business review.

Catalent to buy CDMO Paragon Bioservices for $1.2bn

Paragon Bioservices is a major viral vector development and manufacturing partner for gene therapies. Paragon president and CEO Pete Buzy said: “We are excited to join forces with The post Catalent to buy CDMO Paragon Bioservices for $1.2bn appeared first on Pharmaceutical Business review.

Glaukos touts 5-year study of glaucoma stents

Glaukos  (NYSE:GKOS) said today that a study of its iStent trabecular micro-bypass stents reduced eye pressure in glaucoma patients five years after implant. The same study showed that significantly fewer iStent patients needed add-on medications after five years, the company said. The study showed that newly diagnosed, primary open-angle glaucoma (POAG) patients who received two […]

More device shortages pegged to sterilization plant shutdown

Cardinal Health’s Accu-Trace intrauterine pressure catheter (Image from Cardinal Health) More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant. Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device […]

Penumbra VR device wins FDA clearance

Penumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system. The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases. The exercise routines with the […]

Corindus touts first Japanese CorPath GRX procedures

Corindus Vascular Robotics (NYSE:CVRS) said today that the first Japanese procedures using its CorPath GRX robot-assisted device took place as part of a post-market surveillance study. Waltham, Mass.-based Corindus, which last June won clearance from Japan’s Pharmaceutical & Medical Device Agency for CorPath GRX, inked a distribution deal for Japan in February 2017 that included a […]

FDA approves Intact Vascular’s Tack dissection repair device

The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient […]