The Irvine, CA-based company estimates it could get a PMA for its rechargeable sacral neuromodulation to treat urinary dysfunction and fecal dysfunction sometime in 2019.
The recall was prompted by an incident in which the top detector of a Millennium Nuclear Medical System detached and fell onto the detector below.
The spotlight will be on digital health products at the upcoming BIOMEDevice San Jose show. Hear now from one company making an impact.
FDA is alerting doctors and patients about the risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices.
Sweetch is using artificial intelligence to help change people’s lifestyles who are at risk for diabetes, which is a slightly different method for tackling the disease.
Precise Bio is trying to develop bio-printed eye-related tissues to treat ophthalmic diseases. The company has already transplanted a 3D-printed corneal graft in animals.
Medtronic is the undisputed leader of the drug-coated balloon space, but Philips is vying for an indication that could potentially impact the Dublin-based firm’s hold on the market.
The release of the ST LEUIS trial data comes on the heels of Apple receiving FDA clearance for an ECG app for the Apple Watch.
The Danvers, MA had strong data at the American Heart Association, however the firm’s shares were down as much as 17% on Monday.
The London-based company’s bioconvertible IVC filter had zero instances of tilt, perforation, migration and embolization through follow-up in the SENTRY trial.
The Santa Clara, CA-based company filed its PMA submission with FDA earlier this year and hopes to be able to launch the technology in the first half of 2019.
The Louisville, CO-based company has raised $7.5 million and will use the new capital to help with regulatory approval and the commercial launch of the system.
The Dublin-based company has received FDA approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system with patients on medication for high blood pressure.