News
Jun 29, 2016
Marie Thibault New findings published by The BMJ may give some proponents of speedy device approvals pause. It's well-known that high-risk medical devices...
Jun 27, 2016
Marie Thibault Today, Medtronic announced an approximately $1.1 billion acquisition of HeartWare, one of two major makers of left ventricular assist devices (...
Jun 16, 2016
Marie Thibault Recognizing the fast pace of advancement in software development, FDA is searching for the best way to regulate higher-risk medical software...
Jun 13, 2016
Marie Thibault Dexcom is hoping to gain a non-adjunctive claim for its G5 Mobile Continuous Glucose Monitoring System. A study presented at the American...
Jun 10, 2016
Marie Thibault Medtronic is developing the EV-ICD to avoid transvenous leads, like Boston Scientific's S-ICD, above, but management says the new device will...
Jun 08, 2016
Marie Thibault The Axonics Sacral Neuromodulation System includes the smallest and first rechargeable implant for sacral neuromodulation. Rechargeable...
Jun 07, 2016
Marie Thibault NuVasive continued its buying spree this week, adding a $98 million purchase of Biotronic NeuroNetwork to its acquisitions earlier this year of...
Jun 07, 2016
Marie Thibault Zimmer Biomet is buying spine company LDR Holdings for approximately $1 billion and has high hopes for its future in the rapid growth area of...
Jun 06, 2016
Marie Thibault A standby device in hospitals, the pulse oximeter may eventually get a futuristic upgrade. While it is already a non-invasive way to measure a...
Jun 01, 2016
Marie Thibault For more than two decades, FDA has been categorizing investigational medical devices as either Category A (experimental/investigational) or...