There has been a lot of buzz about Apple's foray into healthcare and reports of the company hiring "dozens" of medical doctors, but what does that actually mean for medtech?
Biomedical engineers at Georgia Tech have developed a smartphone app that uses photos of a patient's fingernails to determine whether the level of hemoglobin in their blood seems low.
FDA said interim results from sampling studies indicate higher-than-expected contamination rates after reprocessing of duodenoscopes currently on the market.
Olympus agreed to pay $85 million to settle a federal investigation of its that began in 2015. A former executive also pleaded guilty and faces up to a year in prison.
Ernst & Young resigned as MiMedx's outside auditor after advising the company that the internal controls necessary for MiMedx to develop reliable financial statements do not exist.
The robotic guidance and navigation system has already been used in surgeries in Greece, Germany, and Italy.
A recent breakthrough in the design of medical device cables is expected to enable a new generation of small, flexible, and intelligent catheters according to Japanese wire and cable supplier Junkosha.
Medtronic agreed to pay a total of $50.9 million to resolve three separate claims against Covidien and ev3, both of which are now part of Medtronic.
FDA proposed a new rule that, if finalized, could motivate more companies to choose the de novo pathway for new devices that do not have a modern predicate.
A new company led by breast cancer survivor Efrat Roman has developed a breast dressing that provides an advanced solution for the diverse post-op requirements of all breast procedures.
The study will evaluate Biosense Webster's Heliostar radiofrequency balloon ablation catheter for the treatment of symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation.
FDA cleared electroCore's vagus nerve stimulator for the preventive treatment of cluster headache in adult patients
From 2015 through 2018, about 20% of 510(k) clearances were based on substantial equivalence to a predicate device that was more than a decade old. Should FDA continue to allow this practice, or should older devices be retired as predicates?