A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.

Mfb Fertility Inc. received CE mark approval for its Proov PdG tests, giving European women direct access to information about ovulation without a prescription. The test enables a woman to test her urine for production of sufficient progesterone to confirm ovulation and favorable conditions for conception.

LONDON – CMR Surgical Ltd. has once again broken the record for a private financing round by a European med-tech company, raising $600 million in a series D funding round. That follows on from two other record-breaking rounds, in which the Cambridge, U.K.-based CMR raised $240 million in a series C in September 2019 and $100 million in the series B round that closed in May 2018. These earlier rounds enabled CMR to complete development and install the first commercial versions of its Versius surgical robots. Now the series D will push the company through to profitability, the company said.

The FDA has posted an update on its surveillance of adverse events for bronchoscopes, noting that the number of medical device reports (MDR) has risen to between 100 and 200 such reports per year in the U.S. However, the agency noted that there are half a million procedures performed with these devices each year in the U.S. alone, and that these data are insufficient to infer a specific incidence of adverse events.

LONDON – There has been a lukewarm reception from the industry to the latest developments in the plan to establish a European health technology assessment (HTA) agency, with concerns from pharma that member states will be able to pick and choose whether to apply joint evaluations in national reimbursement and access negotiations.

PARIS – In France, the Haute Autorité de Santé, or National Health Authority (HAS), recently reported the entry into force of a new plan for "temporary" adoption under social security for innovative medical devices. The aim is to speed up access to the French insurance reimbursement market for medical technology addressing unmet or poorly met clinical needs in the context of serious or rare conditions, or which help disability in France.