After a deal between General Motors and Ventec Life Systems to produce 80,000 ventilators briefly appeared halted, President Trump yesterday ordered GM to proceed under the Defense Production Act. A New York Times report earlier on Friday said the Federal Emergency Management Agency had paused the $1 billion plan, saying it needed time to determine […]
Orthofix completes acquisition of Fitbone limb lengthening system
Orthofix (NSDQ:OFIX) this week said it completed its acquisition of the Fitbone intramedullary lengthening system. Fitbone is designed to lengthen the femur and tibia bones. The acquisition also includes other potential applications of the technology that are in development, including FitSpine for fusion less surgery to treat scoliosis. The system is implanted in the bone […]
Bioventus names new CEO
Bioventus this week said it appointed Ken Reali as CEO, effective April 20. Reali will replace Tony Biel who is retiring on April 30. “I am honored to have the opportunity to lead Bioventus,” Reali said in a news release. “The company’s broad product portfolio, global presence and solid growth have it well-positioned to serve […]
FDA approves BioStage’s esophageal device investigational new drug application
Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was […]
Aegea Medical device to treat heavy menstrual bleeding wins FDA approval
Aegea Medical this week said it won FDA approval for its Mara Water Vapor Ablation System. The Mara System is an endometrial ablation treatment that uses natural water vapor to treat menstrual bleeding. It is designed to be used in a doctor’s office without the need for general anesthesia. Mara is a one-time, two-minute treatment […]
Precision Spine launches posterior cervical stabilization device
Precision Spine today said it has launched its Reform Posterior Occipital Cervical Thoracic System in the U.S. The Reform POCT System is a posterior spinal fixation system that enables stability in the occupy, cervical and thoracic spine during spine fusion. The system is so far indicated for DDD, spondylolisthesis, spinal stenosis, trauma (fracture or dislocation), […]
FDA advises on increasing supply for PPE
The FDA today said it is taking action to increase U.S. supplies to support the manufacturing of personal protective equipment and other devices in response to COVID-19. The FDA said it is facilitating access to critical personal protective equipment (PPE) and devices by engaging with importers and others involved in the import trade community during […]
ChroniSense Medical appoints new CEO
ChroniSense Medical recently announced that it appointed Bridget Ross as chief executive officer, effective February 10. “We are pleased Bridget will bring her talents to ChroniSense as CEO,” Ilan Neugarten, chairman of the board of Rainbow Medical and ChroniSense Medical’s largest investor, said in a news release. “We are confident Bridget’s extensive and diverse leadership […]
MiMedx appoints new CFO
MiMedx recently announced that it appointed Peter Carlson as chief financial officer, effective March 19. Carlson previously served as the company’s executive VP of finance and joined MiMedx in December last year. “I am extremely pleased to have Pete Carlson on board and appointed as our chief financial officer,” CEO Timothy Wright said in a […]
Cardinal Health names new chief financial officer
Cardinal Health (NYSE:CAH) this week said it appointed Jason Hollar as chief financial officer, effective May 12. Hollar succeeds Dave Evans who will continue to serve as the chief financial officer until May 11. “We are pleased to welcome Jason to the Cardinal Health family,” CEO Mike Kaufmann said in a news release. “With his deep […]
European Commission moves to protect personal protective equipment availability during COVID-19
The European Commission this week said it has taken immediate steps to protect the availability of supplies of personal protective equipment in the wake of COVID-19. The Commission is requiring that exports of such equipment outside of the European Union to be subjected to an export authorization by member states. “The challenges presented by the […]
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