Rarecyte Inc., a Seattle-based company making products for tissue and cell analysis, reported picking up $22 million in a series F financing round led by Healthquest Capital.
Augmedics Inc., a Chicago-based startup focused on augmented reality (AR) applications in health care, has scored a 510(k) clearance from the U.S. FDA for its Xvision Spine system. The company launched the device, which provides surgeons with X-ray quality insights into a patient’s anatomy and real-time surgical navigation, on Monday, with distribution slated to begin in the new year. While the FDA has cleared other AR products, Xvision Spine (XVS) is the first to be indicated for guided surgery.
Pq Bypass Inc., of Milpitas, Calif., said that the Centers for Medicare and Medicaid Services (CMS) has agreed to cover its TORUS 2 investigational device exemption (IDE) clinical trial, which is evaluating the Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).
Rarecyte Inc., a Seattle-based company making products for tissue and cell analysis, reported picking up $22 million in a series F financing round led by Healthquest Capital. Also participating in the round were existing investors 5AM Ventures and Ron Seubert, Rarecyte’s founder and chief technology officer. The company plans to use the funds to expand global sales of its instruments and consumables platform in research clinical markets.
Heart failure is a leading cause of disability and death in the U.S., but many cases are diagnosed late due to limited access to echocardiography, the primary method of detecting the condition. To address that need, the U.S. FDA has granted breakthrough device designation to Eko Devices Inc., of Berkeley, Calif., for an electrocardiogram (ECG)-based algorithm that could serve as an easily accessible screening tool for heart failure during routine physical exams.
Medford, Mass.-based startup Sofregen Medical Inc. has picked up $8 million in a series B round led by Anzu Partners LLC. The money is earmarked for continued development of Sofregen’s silk protein-based technology and for commercialization of its U.S. FDA-cleared Silk Voice for people with vocal cord problems.
Perkinelmer Inc., of Waltham, Mass., has won a thumbs up from the U.S. FDA for its GSP Neonatal Creatine Kinase-MM kit. The assay is the first test approved in the U.S. for help in screening newborns for Duchenne muscular dystrophy (DMD), a rare but devastating genetic disorder. While there is no known cure for DMD, earlier screening and diagnosis could lead to improvements in quality of life by enabling earlier and more personalized treatment of symptoms. The kit’s approval opens the door for states to include DMD among the battery of tests newborns typically undergo, such as phenylketonuria, cystic fibrosis and congenital heart disease.
Caresyntax GmbH, a Berlin-based provider of surgical automation, analytics and AI software technologies, picked up $45.6 million in venture funding. The funds will be used to accelerate U.S. and global expansion and support continued development and deployment of Caresyntax products. Participating in the financing were Whiz Partners, a Takeda-back drug discovery gateway investment limited partnership, Plug and Play Tech Center, Barco Healthcare, Mitsubishi Corp., Relyens, IPF Partners and Caresyntax founders Dennis Kogan and Bjoern von Siemens.
