Michael Barbella, Managing Editor01.13.24
Talk about a clean start to 2024: MPO website visitors this past week overwhelmingly favored the latest update to the medtech industry's ongoing ethylene oxide sterilization saga.
On Jan. 8, the FDA revealed that it considers vaporized hydrogen peroxide (VHP) to be an “established method of sterilization” for medical devices. The agency revised its final guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile to list VHP as an example of an Established Category A method of sterilization. The FDA hopes the update will bring about broader VHP adoption, part of its multi-pronged approach to reducing ethylene oxide (EtO) use. Since 2019, the FDA has promoted development of EtO alternatives and implemented programs and initiatives to foster innovation in medical device sterilization. This included making Sterilization Master File Pilot programs to support sterilization process changes, innovation challenges to encourage strategies to reduce EtO emissions and development of new sterilization methods or technologies, and engaging with the industry.
Certainly, the FDA's announcement was the biggest site traffic driver this past week. But it was not the only one: Other pageview paladins came courtesy of Integer Holdings, Medtronic, Boston Scientific Corp., and Abbott Laboratories for their regulatory, financial, and product innovation news.
Integer and Boston Scientific attracted cybervisitors with their respective acquisitions—Integer bought privately-held Pulse Technologies for $140 million to boost its end-to-end development capabilities and manufacturing footprint in targeted growth markets, while Boston Scientific began a deal to acquire Axonics for about $3.7 billion. Boston Scientific's purchase enables the firm to enter the sacral neuromodulation market, where it will compete with companies such as Medtronic.
Medtronic, of course, is no stranger to competition: This past week, it bolstered its fight for continuous glucose monitoring (CGM) market share by gaining CE Mark clearance for the MiniMed 780G system with Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM) that doesn’t need fingersticks or overtape. Its rival, Abbott, responded by integrating the Tandem Diabetes’ t:slim X2 insulin pump with Control-IQ technology with the company's FreeStyle Libre 2 Plus CGM technology.
On Jan. 8, the FDA revealed that it considers vaporized hydrogen peroxide (VHP) to be an “established method of sterilization” for medical devices. The agency revised its final guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile to list VHP as an example of an Established Category A method of sterilization. The FDA hopes the update will bring about broader VHP adoption, part of its multi-pronged approach to reducing ethylene oxide (EtO) use. Since 2019, the FDA has promoted development of EtO alternatives and implemented programs and initiatives to foster innovation in medical device sterilization. This included making Sterilization Master File Pilot programs to support sterilization process changes, innovation challenges to encourage strategies to reduce EtO emissions and development of new sterilization methods or technologies, and engaging with the industry.
Certainly, the FDA's announcement was the biggest site traffic driver this past week. But it was not the only one: Other pageview paladins came courtesy of Integer Holdings, Medtronic, Boston Scientific Corp., and Abbott Laboratories for their regulatory, financial, and product innovation news.
Integer and Boston Scientific attracted cybervisitors with their respective acquisitions—Integer bought privately-held Pulse Technologies for $140 million to boost its end-to-end development capabilities and manufacturing footprint in targeted growth markets, while Boston Scientific began a deal to acquire Axonics for about $3.7 billion. Boston Scientific's purchase enables the firm to enter the sacral neuromodulation market, where it will compete with companies such as Medtronic.
Medtronic, of course, is no stranger to competition: This past week, it bolstered its fight for continuous glucose monitoring (CGM) market share by gaining CE Mark clearance for the MiniMed 780G system with Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM) that doesn’t need fingersticks or overtape. Its rival, Abbott, responded by integrating the Tandem Diabetes’ t:slim X2 insulin pump with Control-IQ technology with the company's FreeStyle Libre 2 Plus CGM technology.