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 […]
COVID-19 investigational vaccine clinical trial underway
A Phase 1 clinical trial for an investigational COVID-19 vaccine is underway at Kaiser Permanente Washington Health Research Institute in Seattle. The open-label trial plans to enroll 45 healthy adults aged 18 to 55 years over a six week period. The first study participant received the vaccine yesterday. Researchers at Kaiser Permanente Washington Health Research […]
Endologix wins FDA approval for abdominal stent graft system
Endologix today said it received FDA approval for its Alto abdominal stent graft system. The company said it received approval based on its regulatory submission that included results from its Elevate Investigational Device Exemption clinical study. Under the terms of the FDA approval, the first 100 patients after commercial launch will be included in a […]
BD seeks authorization for COVID-19 tests
Becton Dickinson (NYSE:BDX) said today it will submit an emergency use authorization request this week to the FDA for a coronavirus test that could be used on the BD Max molecular diagnostic system. The diagnostic system is used in hundreds of laboratories across the U.S., according to the company. “BD is also exploring the development of […]
Ra Medical Systems appoints new CEO
Ra Medical Systems (NYSE:RMED) this week said it appointed Will McGuire as CEO, effective March 30. Andrew Jackson has served as interim CEO since August and will remain as the company’s chief financial officer. “Will’s extensive industry experience, particularly in the vascular space, makes him an ideal fit to lead Ra Medical,” chairman Martin Colombatto said […]
Alcon launches Vivity intraocular lens in Europe
Alcon (NYSE:ALC) today said it launched its Vivity intraocular lens in Europe. The Vivity lens is a non-diffractive lens that reduces a cataract patient’s dependency on glasses. It is available in spherical and topic designs and allows for high-quality vision at far and intermediate ranges, according to the company. “We are excited to introduce Vivity because […]
Soliton Rapid Acoustic Pulse device wins 510(k) premarket notification
Soliton (NSDQ:SOLY) today said it received special 510(k) premarket notification for its Generation II Rapid Acoustic Pulse device. The Generation II RAP device features the same tattoo-removal technology as the first generation but is modified for improved ease of use in physician offices. “The FDA clearance of our Generation II RAP device marks yet another milestone […]
Dexcom appoints senior VP of finance and chief accounting officer
Dexcom (NSDQ:DXCM) this week said it appointed Jereme Sylvain as senior VP of finance and chief accounting officer, which took effect on March 9. Sylvain will be the accounting officer for purposes of the rules and regulations of the Securities and Exchange Commission. Prior to his appointment, Sylvain was Dexcom’s VP and corporate controller and […]
OrthoPediatrics launches Large Fragment Cannulated Screw System
OrthoPediatrics this week said it launched its Large Fragment Cannulated Screw System in the U.S. The screw system is designed to address trauma procedures and treat children with Slipped Capital Femoral Epiphysis. The system features screws in 2mm increments, screw thread run out in the head of the screw, dual lead threads and threaded cannulation. […]
Keystone Heart cerebral embolic protection device wins CE Mark
Keystone Heart this week said it won CE mark approval for its TriGuard 3 Cerebral Embolic Protection device. TriGuard 3 is designed to reduce the risk of cerebral damage by deflecting debris from cerebral circulation during trans catheter aortic valve implantation and other transcatheter heart procedures, according to the company. “Even with increased operator experience […]