Otolith Sound Inc. closed a $20 million series A financing round led by Morningside Ventures for its treatment for chronic vertigo. The latest funding follows a $3.3 million seed financing round and breakthrough device designation in June 2021. The funding will be used to support ongoing clinical programs and its anticipated FDA approval of its noninvasive wearable device Vestibular System Masking (nVSM) technology. Read More
The saga of U.S. FDA regulation of clinical decision support (CDS) software has spanned six years since the passage of the 21st Century Cures Act, yielding two FDA draft guidances and a final guidance that emerged only Sept. 27, 2022. Regulatory attorney Brad Thompson blasted the final guidance for its addition of “time-critical decision making” to the definition of a regulated medical device, one of several features he argued are extra-statutory and which effectively handcuff both developers of CDS and the physicians who use their products to aid in selecting drug and device treatments. Read More
Novo Nordisk A/S received marketing approval from China’s NMPA for its smart insulin pen Novopen Six that automatically collects and stores the date and time of injections and the number of units of insulin that users take. Read More
Getinge AB reported a partnership with Medtronic plc for the Radiant stent, the first covered stent indicated for chimney endovascular aneurysm repair (ChEVAR). This new balloon-expandable stent graft for renal arteries obtained CE mark approval on Sept. 20. Read More
The U.S. Government Accountability Office (GAO) recently published a report on the pandemic-driven expansion of telehealth for Medicare beneficiaries, and pointed to some privacy and security risks of which patients may be unaware. However, GAO also noted that the CMS does not yet have a good handle on the rate of telehealth fraud and has not yet collected reliable data on telehealth outcomes, two gaps that will have to be filled if Congress is to comfortably vote to make permanent some of these pandemic-driven telehealth policies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alivecor, Cap Medical, Concept Medical, Cresilon, Dignio, Dispatchhealth, Illumina, J&J, Long Island Pathology, Metamark Laboratories, Orasure, P4 Clinical, P4 Diagnostix, Pathnostics, Pierian, Reva Medical, Visualdx. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mesh Suture. Read More
