Lifetech Scientific Corp.’s fully degradable iron-based absorbable coronary scaffold showed its safety and efficacy to treat non-complex coronary lesions that have not been previously treated with an interventional device during a three-year, first-in-humans trial.
The U.S. FDA’s recent final guidance for clinical decision support (CDS) software has drawn a second citizen’s petition for withdrawal, this time from a law professor at the University of Florida (UF). Barbara Evans of the UF School of Law asserted that the CDS final “raises constitutional issues” that are of sufficient importance to warrant an investigation led by the FDA commissioner’s office because of what she argues is a disregard for the First Amendment encoded in the guidance.
Rockwell Medical Inc. has acquired the hemodialysis concentrates business of Evoqua Water Technologies LLC for $11 million up front in cash plus two $2.5 million milestone payments at 12- and 24-months following the close of the deal.
Inovedis GmbH received clearance from the U.S. FDA for its Sinefix implant system, which can be used to repair rotator cuff tears. Sinefix allows surgeons to refix the rotator cuff tendon to the bone using a simplified surgical technique that aims to significantly reduce the time and cost of the procedure.
Curvafix Inc. sealed a $39 million series C financing round to support availability of its device, which treats fragility fractures of the pelvis (FFP). MVM Partners led the round with support from Sectoral Asset Management and other returning investors. Sectoral Asset Management led the $10.7 million series B for the company in 2020. The company has raised more than $60 million to date.
Ilasis Laser SAS said it raised $4.8 million to finance commercial development in Europe of its femtolaser surgical instrument, Rx. A group made up of French business angels, Irdi Capital investment SAS, and Nouvelle Aquitaine Coinvestiment SAS (NACO) were involved in this funding round.
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