Fujifilm‘s (TSE:4901) SonoSite subsidiary said earlier this week it appointed Fujifilm vet and current Fujifilm Medical Systems USA and Fujifilm New Development USA prez Takaaki Ueda as its new chair and CEO. Previously, Ueda has also served as Fujifilm global endoscopy systems division GM, the company said. Ueda will replace the departing Masayuki Higuchi who […]
Carmat updates on artificial heart pivotal trial, plans U.S. feasibility study
Carmat (EPA:ALCAR) today announced updates on its bioprosthetic artificial heart pivotal trial in Europe and said it has submitted files to the FDA seeking an early feasibility trial in the US. The Paris-based company said it has received the regulatory go-ahead to launch its European pivotal trial, looking to implant its bioprosthetic artificial heart in 20 patients […]
Carmat gains on French approval to resume artificial heart trial
Carmat (EPA:ALCAR) shares are up today after the company said French regulators approved the resumption of a clinical trial for its artificial heart. France’s national device & drug agency, the Agence Nationale de Sécurité du Médicament, said late yesterday that “Carmat has provided the elements allowing for the resumption of the trial, meeting satisfactory conditions of safety and […]
Carmat rescinds bid to resume artificial heart trial
Carmat (FRA:CXT) said yesterday that it won’t seek to resume implantations of its artificial heart after all, after French regulators suspended a clinical trial last fall after the 5th death in the study. France’s national drug agency, ANSM, suspended the the trial in December 2016 after the patient died. Yesterday Carmat said the patient’s death was […]
France’s drugs agency freezes Carmat implants after 5th death
France’s national drugs agency said today it is ordering artificial heart maker Carmat (FRA:CXT) to freeze implantation of its devices after the death of a 5th patient last month. The company distanced itself from the death, with chief exec Stephanie Piat stating that the artificial heart was not involved and that the last 3 implantations of the […]
Carmat shares gain on pivotal trial launch
French artificial heart maker Carmat (FRA:CXT) said yesterday that it launched a pivotal trial of its bioprosthetic artificial heart, hoping to use the data to win CE Mark approval in the European Union. The news sent CXT shares up 6.5% to $41.18 (€36.92) apiece today in late-day trading in Frankfurt. Carmat’s shares are off 9.8% so far this year, valuing […]
ESC Congress 2015: St. Jude, HeartFlow tout FFR-guided PCI
The European Society of Cardiology Congress conference wrapped up this week in London. Here’s a roundup of news from the overseas meeting of interventional cardiologists, dominated by data on fractional flow reserve technology. FFR: St. Jude touts 5 year data showing long-term benefits St. Jude Medical (NYSE:STJ) released 5-year data from a trial comparing the use […]
BSX aims for double-digit earnings growth | Medtech Wall Street news for the week of May 4, 2015
Carmat: No problem with artificial heart fundamentals despite death
Euronext suspends Carmat shares after artificial heart patient dies
Carmat artificial heart patient ‘never felt so good’
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