Better Therapeutics Inc. reported that the pivotal trial for its BT-001 prescription digital therapy (PDT) demonstrated significant decreases in hemoglobin A1c at 90 days that improved further at 180 days in participants with type 2 diabetes. The study showed a clear dose-response between greater use of the PDT and improvements in blood glucose levels. Read More
The U.K.’s National Institute for Health and Care Excellence (NICE) has added two placental growth factor (PIGF)-based tests developed by Perkinelmer Inc. to guidance on diagnosing suspected preterm preeclampsia. The Waltham, Mass.-based company’s kit and Delfia Xpress soluble fms-like tyrosine kinase 1 (sFlt-1) kit are recommended to screen levels of PIGF and Sflt-1, both key biomarkers in the pathophysiology of preeclampsia. The guidance means health care providers across the U.K. will be able to use the test, along with a standard clinical assessment, to confirm suspected preterm preeclampsia in women from 20 weeks of pregnancy onwards. Read More
Growing collaborations between pharma and technology companies in digital health are beginning to create a new ecosystem in Taiwan that it hopes will increase its value in the global supply chain, speakers said during the BIO Asia-Taiwan conference in Taipei, running July 27-31. Read More
Drug and device makers that offer health care professionals opportunities to earn continuing medical education (CME) points have a fine line to walk when sponsoring those programs, but a new advisory opinion by the Office of Inspector General at the Department of Health and Human Services seems to draw a very clear line around those programs. Read More
While the U.S. Senate Finance Committee is ostensibly investigating how big pharma is using the 2017 tax changes to avoid paying its fair share of U.S. taxes, at least one medical device company has been drawn into the probe and is being scolded for not cooperating. Read More
Med tech patents have been especially vulnerable to litigation in recent years, and a new decision by the Court of Appeals for the Federal Circuit affirms yet again the vulnerability of patents undergoing litigation. The Federal Circuit said nine claims found in two patents held by Becon Medical Ltd., of Batavia, Ill., were invalid due to obviousness, presenting the company a significant loss in its infringement litigation with Talexmedical LLC, of Malvern, Pa. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bausch + Lomb, BD, Caption Health, Micro-Tech, Zimmer Biomet. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Optrascan. Read More
