Olema launched this year’s 76^th US biopharma IPO. Also, investments in regenerative medicines reached a new high, Qiming closed a $1.2bn China-focused VC fund, D3 Bio led recent venture deals with a $200m round, and Bausch sold $2bn worth of notes to pay down near-term debts.

Two Edwards quality experts explain to Medtech Insight how the firm is benefiting by using a new CAPA framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA.

Medtech industry group AdvaMed has developed a registry to share data on how many COVID-19 diagnostic tests are available and where they are, with a goal of foreseeing and nipping in the bud potential test shortages. Thirteen diagnostic manufacturers – including Abbott, Roche, Siemens and Thermo Fisher Scientific – have partnered with AdvaMed on the initiative.

German reimbursement of COVID-19 confirmatory tests has been reduced by one third, a decision that has frustrated both the testing labs and the diagnostics manufacturers who jointly provided the basis of the system that kept the coronavirus to within manageable proportions nationally.