A number of devices, imaging systems and in vitro diagnostics have become available for colorectal cancer (CRC) screening over the years, several of which are of very recent origin, a marker of sustained interest and investment in these products. The problem for industry is that a new randomized trial conducted in Europe suggests that the impact of CRC screening on all-cause mortality is zero compared to no screening, a finding that could prompt policymakers to revisit their stances on screening to the detriment of sales of these devices and diagnostics. Read More
Medical Creations Inc., dba Xtremity, raised $8.1 million in a series B3 financing round to develop a transtibial prosthetic socket, the Xtremitytt. The socket is designed to enable rapid fabrication and adjustments by using a carbon-reinforced polymer that can be shaped and reshaped in the clinic rather than require use of outside facilities. Read More
Andera Partners closed its Biodiscovery 6 fund at €456 million (US$442 million). The venture capital firm will maintain its custom of allocating about two-thirds of the fund to biotechnology and one-third to medical devices and medical technology. The fund just edges past its target of €450 million. It is considerably larger than its immediate predecessor, Biodiscovery 5, which raised €345 million. Read More
Applied Tissue Technologies LLC (ATT) has won U.S. FDA clearance for a negative pressure wound therapy (NPWT) system that eliminates foam as a potential impediment to complete wound healing. ATT CEO Michael Broomhead said negative pressure wound therapy is ripe for a true innovation to kick its Platform Wound Dressing (PWD) and the treatment “into its next generation.” Read More
The Medicare coverage with evidence development (CED) program has served a vital function for coverage of medical technology for a number of years, but staff at CMS apparently see room for improvement. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Endologix, Glucotrack, Iradimed, Neuspera, Plexision, Pq Bypass. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Limacorporate. Read More
