Preceptis Medical today announced FDA clearance that allows placement of its Hummingbird tympanostomy tube system in an ENT surgeon’s office. Officials at Maple Grove, Minn.–based Preceptis say the Hummingbird system significantly reduces trauma and procedure time for ear tube placement in young children. Kids receiving the ear tubes don’t need general anesthesia, and they don’t […]
Philips wins FDA approval for new automated external defibrillators
Royal Philips (NYSE:PHG) announced today that FDA has granted premarket approval for the company’s HeartStart FR3 and HeartStart FRx automated external defibrillators. The HeartStart FR3 is a professional-grade AED. It includes advanced features for medical personnel and first-responders who need to treat a cardiac arrest. The HeartStart FRx is a public-access AED. It features what Philips […]
Perimeter Medical Imaging to go public in Toronto
Perimeter Medical Imaging — creator of AI-based medical imaging tools for cancer surgery — plans to go public on the TSX Venture Exchange in Toronto on the week of June 29. The Toronto- and Dallas-based company is going public at the same time that it enters the commercial stage for its proprietary, FDA-cleared OCT imaging […]
Tandem Diabetes Care acquires Sugarmate mobile app
Tandem Diabetes Care (NSDQ:TNDM) said today that it has purchased Sugarmate — as mobile app that helps people better manage their diabetes. Financial terms of the deal were not disclosed. Nearly 30,000 people relying on insulin pumps or multiple daily injections presently use the Sugarmate app. Get the full story on our sister site Drug Delivery […]
GE Healthcare launches chest X-ray AI to better spot COVID-19
Officials at GE Healthcare (NYSE:GE) think the company’s new Thoracic Care Suite — a collection of eight AI algorithms from Lunit Insight CXR — could help clinicians in the fight against COVID-19. The AI suite, launched today, quickly analyzes chest X-ray findings and flags abnormalities for radiologist review, according to GE. It can spot potential pneumonia […]
Endologix recall of abdominal stent graft system is Class I
Endologix (NSDQ:ELGX) is warning customers that material weakness during the manufacturing process is causing polymer leaks during implantation of its Ovation iX abdominal stent graft system. The FDA today gave the recall a Class I designation — its most serious level. Out of 12,763 Ovation iX systems sold between August 2015 and May 2020, there were […]
Dexcom CEO sees a new market for continuous glucose monitors after COVID-19
Could in-hospital use of continuous glucose monitors become a new normal after the COVID-19 pandemic? Dexcom CEO Kevin Sayer thinks so. As the pandemic ramped up in March, FDA issued temporary guidance allowing increased remote monitoring of hospital patients in order to limit contact with hospital staff. The guidance included CGMs made by companies such […]
Moody’s lowers its medical device industry earnings forecast
Medical device industry earnings will remain flat over the next 12 to 18 months as people hold off on medical procedures amid the COVID-19 pandemic and resulting recession, according to a new report from Moody’s. Moody’s had previously projected of 2–4% annual growth. “While underlying positive trends remain, including ongoing innovation and favorable longterm demographics, […]
Former Eli Lilly researcher joins Bigfoot Biomedical as chief medical officer
Bigfoot Biomedical has brought on Dr. Jim Malone — a 21-year clinical research veteran at Eli Lilly & Co. — as its chief medical officer, the diabetes treatment tech company said today. Malone, an endocrinologist specializing in diabetes, also spent 12 years in clinical practice. Get the full story on our sister site Drug Delivery […]
Siemens Healthineers wins EUAs for additional COVID-19 antibody tests
More than a week after granting EUAs for COVID-19 antibody tests produced by Siemens Healthineers (ETR: SHL), FDA has authorized additional tests from the German medtech giant. The new EUAs, granted June 8, are for tests running on Siemens Healthineers Dimension Vista and Dimension® EXL systems. The tests already started shipping on May 29. Siemens Healthineers previously […]
Okami Medical raises $7.2m to support vascular occlusion system
Months after the first use of its LOBO vascular occlusion system on patients, Okami Medical has raised more than $7.2 million. The Aliso Viejo, Calif.–based company raised the money from 18 investors, according to an SEC Form D filed June 10. After securing FDA clearance in late 2019, Okami Medical announced the first use of […]