Dia Imaging Analysis Ltd. has inked a collaboration deal with Google Cloud to increase access to its automated ultrasound analysis tools. The agreement will allow practitioners to access Dia's software tools to analyze ultrasound images anywhere they can reach Google Cloud, bringing decision support to varied clinical or remote locations.

Orthofix International NV has won FDA approval and CE mark for its Physiostim bone growth stimulators to spur healing in extremity nonunion fractures. Physiostim's noninvasive pulsed electromagnetic field (PEMF) treatment has expanded treatment possibilities for patients with bone fractures that have not yet healed.

The FDA has granted de novo approval to 23andme Inc. for its report on BRCA1 and BRCA2 risk for developing breast, prostate or ovarian cancer. The direct-to-consumer (DTC) saliva test can provide insight on three genetic mutations linked to the cancers, most commonly found in patients of Eastern European, or Ashkenazi Jewish heritage, which account for a relatively small portion of patients. There are more than 1,000 mutations of the BRCA gene, and the test is not intended to diagnose or rule out the presence of mutation, or increased risk of the particular cancers due to other factors.

Boston Scientific Corp. has acquired private company Emcision Ltd., bringing the firm's Habib EndoHPB probe under its endoscopy division. The Habib endoscopic bipolar radiofrequency device is used to coagulate tissue in the gastrointestinal tract (GI) in treatment of patients with pancreaticobiliary cancers. Financial details of the transaction were not disclosed.

Stimguard LLC will begin enrollment for a head-to-head study of its Chronic Affarent Nerve Stimulator (CAN-stim) against Medtronic plc's gold standard Interstim device in treatment of urgency urinary incontinence from over active bladder (OAB) not controlled by medication, following FDA approval of the trial with an investigational device exemption (IDE). Privately held Stimguard's device can be implanted in a physician's office with ultrasound guidance, avoiding a surgical procedure and general anesthesia required for the sacral device.

Private diagnostics company Idx LLC reported its artificial intelligence (AI) system to detect diabetic retinopathy (DR) has met pivotal trial endpoints to assess patients for the disease in primary care. The 900-patient trial indicated the company's system, Idx-DR, is able to determine, within a few minutes, the presence of diabetic retinopathy among diabetic patients during a physician office appointment. The FDA granted breakthrough device designation and expedited review to the company earlier this month; the device has been under review since the start of 2018 with anticipated approval later in the year.

Abbott Laboratories has inked a deal with Surmodics Inc. to collaboratively develop, trial and seek EU and U.S. approval for the Surveil drug coated balloon (DCB) in treatment of superficial femoral artery. Abbott will obtain exclusive global commercialization rights for Surveil under the agreement, which includes a $25 million initial payment to Surmodics and $67 million in potential milestone payments. Surveil is being assessed in a U.S. pivotal, randomized trial, TRANSCEND.

Reva Medical Inc. has secured early CE mark and clinical implant of its 2.5 millimeter Fantom Encore bioresorbable scaffold, bringing a slimmed down version of its Fantom device to the European market. The first surgical implantation of the sirolimus-releasing scaffold with a 95 micron strut profile was completed at Universitätsklinikum Schleswig-Holstein in Kiel, Germany. Fantom Encore is X-ray visible, and uses Reva's Tyrocore polymer.

Molecular diagnostics company Diacarta Ltd. raised $45 million in its most recent series B funding, and will apply the capital to expand its liquid biopsy cancer detection platform. The cash flow will be used toward Diacarta's XNA technology platform to detect cancer at an early stage, and to expand globally.

Molecular diagnostics company Diacarta Ltd. raised $45 million in its most recent series B funding and will apply the capital to expand its liquid biopsy cancer detection platform. The cash flow will be used toward Diacarta's XNA technology platform to detect cancer at an early stage and to expand globally. The round was led by Fortune Fountain Capital and included Good Health Capital. The company closed an $8 million series A funding in January 2015.