Developers of blood tests for the early diagnosis of Alzheimer’s disease (AD) are poised to see a spike in demand, following the FDA’s accelerated approval on Tuesday of Cambridge, Mass.-based Biogen Inc.’s AD drug treatment Aduhelm (aducanumab). The FDA’s decision paves the way for AD assays to move beyond aiding in drug development toward addressing ongoing issues with undiagnosed cases. Read More
The FDA’s two-day advisory hearing yielded recommendations for risk designation for a number of product types, such as plunger-like joint manipulators, which received a unanimous endorsement for a class III designation. The advisory panel was split on the risks associated with electro-acupuncture stimulators, which the FDA must now decide whether to classify as a class III device, a move that would force a number of existing devices into clinical trials for an expensive and time-consuming PMA application. Read More
Heralded as a potential turning point for U.S. innovation in the 21st century, the U.S. Innovation and Competition Act, S. 1260, is a big step closer to becoming law. The Senate voted 68-32 June 8 to pass the sweeping $250 billion bipartisan bill intended to give the U.S. an edge over China when it comes to innovation and investment in several critical industries, including artificial intelligence, biotechnology and quantum computing. Read More
Eyeyon Medical Ltd. has won CE mark approval for its flagship product, Endoart, a synthetic implant that replaces the human endothelium, which the body can’t regenerate. Designed to treat chronic corneal edema, it could help to reduce the long wait times for human donor corneas. Approval was based on a first-in-human trials involving 22 patients who received Endoart implants and were followed for 24 months. Read More
Cymedica Orthopedics Inc. received FDA clearance for its Intellihab system to reduce pain associated with osteoarthritis in the knee. The system uses neuromuscular electrical stimulation to strengthen muscles supporting the knee without requiring typical exercises such as squats that could increase pain and further degrade the joint. Intellihab includes a knee brace that emits the pulses and a smartphone app patients use to track and manage the therapy. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) issued a new document on June 8 responding to the National Institute of Standards and Technology (NIST) call for position papers to fulfill the President’s Executive Order on improving the federal government’s cybersecurity. It details how CDRH is planning to do its part to advance the shared goal within medical devices. Read More
Medtrace Pharma A/S raised $30 million in a series B round to ramp its platform for production, infusion and analysis of 15O-water in medical imaging. Swiss-based Swisscanto Invest, along with fund managers ATP and Bankinvest group from Denmark, are the lead investors. “We can now ramp our European and U.S. expansions plans in myocardial perfusion imaging and in other indications in need of perfusion data,” Martin Stenfeldt, CEO and co-founder of Medtrace, told BioWorld. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Able Medical Devices, Canon Medical Systems, Caremax Medical Group, Cathx Medical, Dedalus Group, Deerfield Healthcare Technology Acquisitions, Global Access Diagnostics, IMC Medical Group Holdings, Kumocare, Livful, Medline, Neupath Health, Obviohealth, Sofinnova Partners, Spectramed, Syntheticmr, Visionquest Biomedical, Zeus Industrial Products. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cymedica Orthopedics, Ibex, Subtle Medical. Read More
