Officials moved to stop the plastic syringes made by two Chinese manufacturers from entering the U.S. after finding quality system failings.
Patients can self-collect the samples in locations such as retail pharmacies, which could encourage more people to get tested.
The partners are developing a robotically steered diagnostic catheter for use with Stereotaxis’ cardiovascular robots.
Diabetes tech companies shared updates on new products, largely focused on Type 2 patients, in Q1 earnings calls.
CEO Mattias Perjos said the action will have “some negative financial impact,” but the total effect will depend on customers' response.
Hospitals should discontinue use of the devices and return them due to potential safety risks, Boston Scientific wrote in a March letter to customers.
In the latest notice, which follows a February recall of the device for a separate issue, Abbott took action due to reports of blood leakage and air entrapment.
For medical products, the tariff increases focus on syringes, face masks and gloves — areas where the U.S. has sought to ramp up domestic production after the start of the pandemic. The U.S. imported ...
FDA inspectors found Cue made unauthorized changes to its COVID-19 kits that “reduced the reliability of the tests.” ...
In addition to the partnership announcements, Dr Sharp also celebrated the one year anniversary of the launch of the Galvan+ ...
Megadyne discontinued the product globally after receiving four reports of patients being burned in procedures where the electrode pads were used.
Michelle Tarver, an FDA official, said a new program is meant to advance health equity by considering people’s living conditions as part of medical device design.