We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Insightec’s Exablate ultrasound cancer therapy is safe and effective against prostate cancer, according to the results of a multisite study reported in The Lancet Oncology. Read More
Angel Medical Systems, a device company that offers an implantable cardiac monitoring and alerting system, was hit with a Form 483 for corrective and preventive action (CAPA) and documentation lapses observed during a March inspection of its Eatontown, N.J., facility. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) announced strategic priorities for 2022 to 2025 earlier this year that will mean some challenges as well as potential benefits for devicemakers, including increased attention to diversity in clinical trials, according to one prominent regulatory attorney. Read More
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