Fibromyalgia is an often debilitating condition, characterized by chronic pain throughout the body that can leave patients fatigued, depressed and unable to perform even the simplest of activities. While a handful of drugs have been approved to treat this autoimmune disorder, they can have unpleasant side effects and do not benefit all patients. To that end, the FDA has granted a breakthrough device designation to Neurometrix Inc.’s Quell wearable neurostimulation device for treating the symptoms of fibromyalgia in adults. Read More
The European Commission has posted the first sets of standards for the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The new publications had been long-awaited as more and more manufacturers leverage voluntary consensus standards to comply with requirements across regulatory bodies while promoting international harmonization. Read More
Responding to the growing number of state-sponsored cyber threats to health care and other key sectors and to the compromise of the Microsoft Exchange Server, which was disclosed in March, Canada, the EU, U.K., U.S. and other NATO allies issued statements July 19 laying out expectations and markers for how responsible nations behave in cyberspace and specifically calling out China’s “malicious cyber activity.” Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) had previously waded into a sea of opposition from device makers and medical societies alike in its proposal to eliminate the inpatient-only (IPO) list. The new administration at CMS has proposed to reverse that move and sustain the IPO, which should alleviate concerns that outpatient procedures will ding the reputations of these devices. Read More
Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics. Read More
Cellares Corp. added Poseida Therapeutics Inc. to its expanding early access partnership program (EAPP) for the company's Cell Shuttle, a highly specialized "factory in a box" solution for development of cell therapies. San Diego-based Poseida brings two autologous CAR-T product candidates to the program and joins Pact Pharma Inc. and Fred Hutchinson Cancer Research Center in the EAPP. Read More
The U.K. National Institute for Health and Care Excellence (NICE) said devices used to repair paravalvular leak around replaced mitral or aortic valves should only be used in studies because of a limited set of data on efficacy. Read More
In a deal worth up to $108 million, ophthalmic startup Eluminex Biosciences Ltd. has licensed the global rights to Fibrogen Inc.’s biosynthetic cornea derived from recombinant human collagen (RHC) type III intended to tackle corneal blindness. Read More
DUBLIN – Panakès Partners SGR SpA has raised €150 million (US$177 million) in a first close of its second fund and is looking to secure a final tally of €180 million by year-end. That would represent more than twice the size of its first fund of €80 million and reflects its move into therapeutics investing. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3a-diagnostics, Agilent Technologies, Clx Health, Guided Therapeutics, Health Decisions, Micronoma, Novocardia, Ortho Regenerative Technologies, Pacific Biosciences, Premier Research, Quest Diagnostics, San Omniome, Shandong Yaohua Medical Instrument, Terumo Europe, Theator, Thomas Scientific, Xphyto Therapeutics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neurometrix, Venus Concept. Read More
