Tandem Diabetes Care (Nasdaq:TNDM) announced today that it completed its previously announced acquisition of AMF Medical. San Diego-based Tandem announced plans to acquire the maker of the Sigi patch pump for insulin delivery last month. Switzerland-based AMF Medical does not offer Sigi commercially. The system received FDA breakthrough device designation just over one year ago. The […]
MassDevice Article Archive
Asensus Surgical wins CE mark approval for expanded machine learning
Asensus Surgical (NYSE:ASXC) announced today that it received CE mark for an expansion of machine vision capabilities with its surgical robot. The approval expands machine vision for the previously cleared Intelligent Surgical Unit (ISU) of the Senhance system. This regulatory nod makes the expanded ISU capabilities available across Europe, Japan and the U.S. The FDA […]
iCad announces CFO transition
iCad (Nasdaq:ICAD) announced today that its board of directors approved the appointment of Daniel Shea as interim CFO. Shea takes over as interim CFO, effective immediately. The cancer detection and therapy tech company also launched a search for a full-time CFO. Steve Sarno previously held the interim CFO role. The company said in a news […]
DePuy Synthes to pay $9.75M to resolve surgeon kickbacks case
Johnson & Johnson’s DePuy Synthes has settled with federal prosecutors over allegations that it provided a Massachusetts-based surgeon with $100,000 worth of free products to win business. As part of the $9.75 million settlement agreement, DePuy Synthes admitted that it provided free cages, rods, screws, plates and modular access and retraction systems to the surgeon […]
Fresenius Medical Care joins health equity pledge
Fresenius Medical Care announced today that it joined the Zero Health Gaps Pledge at the World Economic Forum in Davos, Switzerland. As part of the Global Health Equity Network (GHEN), the pledge brings together stakeholders from the public and private sectors. In line with the UN Sustainable Development Goals, they aim to advance a collective […]
CardioRenal Systems wins FDA breakthrough nod for RenalGuard Therapy device
CardioRenal Systems announced today that it received FDA breakthrough device designation for its RenalGuard Therapy device. Milford, Massachusetts-based CardioRenal Systems designed the device for preventing acute kidney injury (AKI). It’s for patients at risk for cardiac surgery-associated AKI. RenalGuard protects the kidneys with personalized, active hydration. The system maximizes urine output while balancing hydration. It […]
Able Medical launches Valkyrie looped sternotomy sutures
Able Medical Devices announced today that it launched its Valkyrie looped sternotomy sutures for use after open heart surgery. Marquette, Michigan–based Able Medical designed the stainless steel sutures to close a patient’s chest after open heart surgery. Compared to traditional wire sutures, Valkyrie doubles the surface area of single wires and provides a more robust […]
Getinge launches new ventilator
Getinge this week launched its new Servo-c mechanical ventilator that offers lung-protective therapeutic tools for pediatric and adult patients. The company aims for Servo-c to make healthcare accessible and affordable for more hospitals, according to a news release. Its design simplifies respiratory support, Getinge said. “Lung protection challenges come in many shapes and sizes,” said […]
FDA extends shelf life of some popular COVID tests
The FDA announced today that certain COVID-19 diagnostic tests under emergency use authorization now have a longer shelf life. Diagnostics made by Abbott, Maxim Biomedical and iHealth Labs all received extensions for their expiration dates. The Abbott BinaxNow COVID-19 antigen self-tests now have a shelf life of 22 months. Previously, the popular test had a […]
Novocure announces leadership team restructuring
Novocure (Nasdaq:NVCR) today announced organizational changes for its leadership team as it prepares for future growth. The company said the changes became effective Jan. 17. Pritesh Shah, Novocure’s chief commercial officer, transitioned into a new role as chief growth officer. His responsibilities include product and portfolio strategy, brand management, launch framework and market access/intelligence. He […]
Surmodics announces regulatory delay for its SurVeil balloon
The FDA noted more information on biocompatibility and labeling is needed.
The FDA has indicated that Surmodics’ Surveil drug-coated balloon premarket approval application is not approvable. According to an FDA letter to the company, Surmodics’ Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment to Surmodics’ PMA application to […]