AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a US and China-based biotechnology company focused on early cancer screening and detection, announced today that on December 30, 2021, the Company’s Class III medical device for lung cancer auxiliary diagnosis has completed and passed stringent and rigorous registration tests at the testing laboratory designated by the National Medical Products Administration (NMPA), China’s regulatory agent for medical products. China’s extensive Class III medical device registration tests included medical device performance tests related to accuracy, precision, stability, linearity, accuracy and repeatability in sample addition, cross-contamination, electromagnetic compatibility (EMC), and reliability and performance under various environmental conditions. Completion of the NMPA registration tests is a significant milestone toward obtaining a Class III medical device registration certificate. Following completion of the registration test, the remaining major step prior to final approval of a registration certificate will be clinical trials which will begin in the first quarter of 2022 with two qualified clinical trial medical institutions.
Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation to its Osteo-Adapt SP Spinal Fusion implant indicated for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis.
The FDA has cleared a next-generation system to continuously monitor patients’ blood pressure while they’re undergoing surgery without the use of inflatable cuffs or invasive arterial catheters.
Medcura, Inc., a commercial-stage medical device company, today announced it has raised $7.4 million in private equity to support its growing product line and development of its lead surgical candidate for clinical evaluation. The financing includes the sale of Series A Preferred stock as well as common stock based, in part, from certain investors benefitting from a Maryland Investment Incentive Program.
Why would any sane person leave the bleeding-edge medical device space after 25 years for a biotech startup? The medical device world allows you to represent products where you see the benefits to patients immediately. We had the privilege of wearing scrubs and offering our expertise in the procedure room. I was fortunate to work with some of the greatest cardiovascular minds in the world. Having built that trust and credibility is something I’ll never forget. So why move along?
Critical Need For Electrophysiology Devices To Treat Pediatric Heart Patients WASHINGTON – (March 23, 2021) – Congenital heart disease (CHD) affects six out of 1,000 babies born in the U.S. [….]
In the heart of pharmaceutical and medical innovation lies an undiscovered treasure that provides a pathway for med-tech innovation, the Maryland Development Council (MDC). The council is a MedTech Startup Studio that works with inventors to develop their ideas into working prototypes and marketable products.
Thomas (“Tommy”) Miller, Esq., is Senior Counsel and Life Science Lead at Nixon Gwilt Law and is licensed in Virginia, Washington, D.C., and Maryland. Tommy has supported innovation and served clients in the healthcare and life science industries for over 10 years.
Deborah Hemingway, Ph.D. named CEO of Maryland Development Center (MDC)
Mr. Schneider is a mechanical design engineer with over 20 years of engineering experience in the design of complex electromechanical prototypes and products. He earned a BS in mechanical engineering with Honors from the University of Maryland, College Park, and a MSE in mechanical engineering from Johns Hopkins University with a focus on haptics and medical robotics. In 2012, he founded Root3 Labs to focus on practical R&D for the medical device and defense industries.