Minneapolis-based startup Nuvaira Inc. has received breakthrough device designation from the U.S. FDA for its Dnerva lung denervation system to reduce the risk of moderate-to-severe exacerbations of chronic obstructive pulmonary disease (COPD) in patients receiving optimal care. The bronchoscopic procedure works by disrupting pulmonary nerve input to the lung, improving symptoms and stabilizing lung function.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chembio Diagnostics, Edwards, Genetron Health, Laminate Medical Technologies, Nuvaira, Surmodics.
The U.S. FDA’s Accreditation Scheme for Conformity Assessment program (ASCA) seems to promise a much less burdensome approach to device performance testing, but several stakeholders have made the case that as written, the draft guidance for the ASCA pilot does little more than create another layer of review of device testing, thus defeating the point of making more extensive use of testing labs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Medtronic, Opti Medical Systems.
Hydrocephalus involves the buildup of excess fluid in the brain. It affects more than 1 million people in the U.S. – most of them children – and can result in brain damage and related neurological impairments. Shunt implants are the standard treatment to drain that fluid, but more than half of them fail within the first couple of years of placement.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Roche, Synedgen, Transit Scientific.
The implementation date for the EU’s new med-tech regulatory framework has been pushed back a year, giving device makers much-needed breathing room for compliance work. At the same time, the International Organization for Standardization (ISO) has not fulfilled the planned May update of its device clinical investigations standard, ISO 14155.
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