Former FDA Commissioner Stephen Hahn is being asked to spill the beans on political interference at the U.S. agency during the emergence of COVID-19 last year.

The FDA gave Pear Therapeutics Inc. a second breakthrough device designation with the company’s Reset-A prescription digital therapeutic (PDT) for alcohol use disorder getting the regulatory agency’s speed pass. The news comes a week out from the vote of stockholders of blank-check company Thimble Point Acquisition Corp. Inc. on a combination with Pear that will take the digital therapeutic company public.

Medical science has not yet convincingly duplicated the remarkable properties of cartilage, an omission that sustains an epidemic of life-altering knee replacement surgeries. Anthony Ratcliffe, CEO of Synthasome Inc., of Del Mar, Calif., said on a recent FDA webinar that companies might want to consider the lowly goat as the animal model of choice in preclinical studies of cartilage products because “the cost, ease of management, and the social aspects were all manageable” with goats.

Fujirebio Europe NV launched two new cerebrospinal fluid (CSF)-based immunoassays for Alzheimer’s Disease (AD) on its Innotest platform. It’s the first product launch for the company following a collaboration agreement signed with Adx Neurosciences NV in September 2020. The assays will test for neuronal pentraxin-2 (NPTX2) and soluble triggering receptor expressed on myeloid cells 2 (STREM2). Both neurology biomarkers are linked to synaptic dysfunction and neuroinflammation which are considered core features of AD progression. Fujirebio said the new tests will support existing research for AD drug development.

The FDA has issued new risk classification orders for two series of products, including in vitro diagnostics for hepatitis C, two of which the agency down-regulated from class III to class II. However, blood lancets for multiple uses on more than one patient has been elevated from class I to class III, a change that has no impact on any products currently available on the U.S. market.

Pulse Medical Imaging Technology Co. Ltd.’s latest trial showed its quantitative flow ratio (QFR) guidance provided a 35% risk reduction in the one-year rate of major adverse cardiac events, compared to standard angiography guidance. QFR, developed by Pulse, could be used to guide the strategy and optimization of percutaneous coronary intervention.

TORONTO – Despite high tech costs and tight public sector budgeting, COVID-19 has driven Canadian procurement offices to echo a sentiment uttered by average Canadians, “Damn the costs. Give us something that really works.”