SBRI Healthcare alumni and Cambridge-based Owlstone Medical has announced that it has raised $15 million (£11 million) to drive the global commercialisation of its Breath Biopsy® platform.
Canon Medical launches new version of Aplio i900 cardiovascular ultrasound system - Medical Devices Business Review
Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism — meaning the digital health startup is now positioned to submit an application for full FDA clearance.
Siemens AG has announced a plan for its Siemens Healthineers business to go public in the first half of the year, according to a company statement. It’s not the first time the German medical imaging and diagnostic business has made its intentions to file an IPO known, but perhaps the company is betting on a more receptive audience in the current market.
On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug and device reform—the Opinion on Strengthening the Reform of the Drug and Medical Device Review and Approval Process to Encourage Drug and Medical Device Innovation (“Opinion 42”).
Healthcare firm Abbott will provide its PathVysion HER-2 DNA FISH probe kits for use in Angle's breast cancer liquid biopsy study.
Paige.AI, a new company focused on revolutionizing clinical diagnosis and treatment in oncology through use of artificial intelligence (AI), launches today as it announces two major milestones
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
Amazon and two other American titans are trying to shake up health care by experimenting with their own employees’ coverage. By Chinese standards, they’re behind the curve.
A machine learning technology developed to spot dangerous medical conditions before they worsen has shown its value in a trial.
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