The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.
Rhythm Diagnostic Systems SA (RDS) received €1 million (US$1.1 million) from Capital Grand Est, the first venture capital (VC) firm to join its investor pool, taking its total seed capital raised to €13 million. RDS will use the funds to progress toward the next stages in the development of its Multisense product, a remote patient monitoring solution, including market launch, once it receives CE mark from the European authorities expected by the end of the year.
Dentists at Melbourne, Australia-based 3DSG Pty Ltd. are seeking patent protection for a plug and socket set for use in a mandibular advancement splint set for treating snoring or sleep apnea.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Masimo, Sleepiz, Techmah, Xēnix, Vuze, ZKR Orthopedics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affamed Technologies, Affamed Therapeutics, Envoy Medical, Haemonetics, Hologic, Inovus Medical, Opsens, Sifi, Thermedical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Karius, Neurasignal.
For individuals who develop an unexpected psychosis, there is something to be said for testing them for autoimmune antibodies. And something against. At the 36th Congress of the European College of Neuropsychopharmacology (ECNP) this week, the topic was worth a controversy session, where speakers presented the pros and cons of the approach. Currently used tests have a specificity of 99%. But as Ester Coutinho, consultant neurologist at the University of Coimbra, pointed out, the validity of diagnostic tests depends on the prevalence of the disorder one is looking for as well. Coutinho estimated that autoimmune psychoses account for 1% of psychoses overall.
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