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Many digital health startups have the online sizzle without the clinical evidence steak, suggests a new study that shows fewer than half of companies surveyed have ever reached the point of clinical trials or regulatory filings. Read More
Finland-based Medix Biochemica is strengthening its presence in the in vitro diagnostic (IVD) market with the purchase of Bioresource Technology for an undisclosed sum. Read More
Carthera, a French medtech company that makes ultrasound-based medical devices to treat brain disorders, has earned the FDA’s Breakthrough Device designation for its SonoCloud-9 system. Read More
The antimicrobial susceptibility testing device received a Breakthrough Device designation from the FDA earlier this year, but it has not yet received the agency’s 510(k) clearance. Read More
The FDA offers recommendations on nonclinical assessments of containment systems used with laparoscopic power morcellators (LPMs) — including testing for permeability, burst strength and leakage — in a new draft guidance. Read More
A new study evaluating Cardiologs’ deep learning tool for identifying patients at risk for atrial fibrillation (AFib) showed that it outperformed regular 12-lead electrocardiogram (ECG) testing. Read More
Due to its ability to differentiate between natural and vaccine-based antibodies, the PictArray test could help in future vaccine development, the company said. Read More