BOSTON – The FDA's Center for Device and Radiological Health (CDRH) released draft guidance on Monday aimed at encouraging the use of patient input in medical device clinical trials and helping sponsors understand how they can use patient engagement to improve the design and conduct of investigations.
The U.S. Department of Defense's Defense Advanced Research Projects Agency (DARPA) has tapped Tempe, Ariz.-based startup Inanobio Inc. to build an epigenetic sequencer capable of detecting exposure to weapons of mass destruction (WMDs). The four-year contract, valued at up to $5.4 million, is part of a larger DARPA $27.8 million contract awarded to a consortium led by the Icahn School of Medicine at Mount Sinai Health System in New York under the agency's Epigenetic Characterization and Observation (ECHO) program.
Bayer AG led a $40 million series B financing for Informed Data Systems Inc. (IDS) and its One Drop diabetes management platform. The pharma giant also inked a licensing agreement to leverage IDS, which does business as One Drop, in therapeutic areas beyond diabetes and secured a seat on One Drop's board of directors.
Royal Oak, Mich.-based liquid biopsy startup Oncocell MDx Inc. reeled in $22.2 million in a series B financing led by Savitr Capital, with participation from existing investors. The company, which has raised a total of $30 million to date, plans to use the proceeds to support ongoing development of its pan-disease immunogenomics platform and commercialization of its novel noninvasive blood-based tests.
Royal Oak, Mich.-based liquid biopsy startup Oncocell MDx Inc. reeled in $22.2 million in a series B financing led by Savitr Capital, with participation from existing investors. The company, which has raised a total of $30 million to date, plans to use the proceeds to support ongoing development of its pan-disease immunogenomics platform and commercialization of its novel noninvasive blood-based tests.
The FDA has granted breakthrough device designation to Sonivie Ltd.'s Therapeutic Intra-Vascular Ultrasound (TIVUS) system for the treatment of pulmonary arterial hypertension (PAH). Early clinical studies suggest that the catheter-based system could stabilize or reduce pressure in the pulmonary vasculature of PAH patients, a population with an average survival rate of five years.
