BioWorld MedTech October 10, 2023

PCCP concept at risk of being subsumed in debate over artificial intelligence

The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies. Read More

Advamed’s Whitaker more bullish on VALID Act in light of FDA draft rule for LDTs

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.

RDS closes €13M seed round, eyes on CE Mark

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. Read More