Therabionic GmbH received U.S. FDA humanitarian device exemption (HDE) for its P1 device for at-home treatment of hepatocellular carcinoma, which accounts for 80% of all liver cancers, in patients who have failed first- and second-line therapies.
The funding environment continues to be challenging for companies in the health care sector, and even more so for early-stage med-tech companies, delegates heard at the LSX Investival Showcase in London. Med-tech companies were told that they had to be lean, constantly work on building relationships with investors and not to give up because there is money out there for innovative technologies that can save people’s lives.
Researchers from the University of Michigan have filed for patent protection of methods and systems to identify actual esophageal tissue changes and/or damage during cardiac ablation procedures.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Therabionic.
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review (IPR) process has drawn fire from inventors as a patent-killing machine. The Senate is considering a new bill to address some of these concerns, but witnesses at a hearing this week were anything but united in their assessment of the status quo, making it difficult to forecast the fate of this latest effort at patent reform.
The U.S. FDA granted Roche Holding AG breakthrough device designation for its Elecsys Neurofilament Light Chain test for multiple sclerosis. The Elecsys NfL test can aid in the detection of disease activity in adults, 18-55 years old, with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis. It also provides critical information for managing the disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acon, Arup, 2curex.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Establishment Holdings, Owlet, Schemaview.
Recor Medical Inc. finally received U.S. FDA approval for its Paradise ultrasound renal denervation (RDN) system for the treatment of hypertension after more than ten years of research and clinical trials. Paradise is the first RDN system to reach the U.S. market, and its approval is good news for the technology after years of disappointment in the data from trials and concerns over the efficacy of RDN devices.
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
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