ReShape Medical's Integrated Dual Balloon System just burst regulatory barriers, becoming the first device of its kind to earn the FDA's stringent PMA approval for novel, high-risk devices. The Fierce 15 company's device consists of two salt water-filled silicon balloons that reduce appetite by taking up space in the stomach "or by other mechanisms that are not yet fully understood," according to the FDA.
Last month, the FDA scheduled a September panel meeting to take a hard look at Bayer's controversial birth control device, Essure, after getting complaints of clinical trial fraud and serious side effects tied to the product. Now, the agency is facing more pushback from women campaigning against the device, who claim that regulators purposely selected the panel meeting date to coincide with a visit from the pope.
Diagnostic assays that usually require a desktop reader that costs several thousand dollars can now be done using a 3-D printed plate that attaches to a smartphone. Even better, the accuracy of the results achieved are comparable to standard laboratory equipment.
Medtronic CEO Omar Ishrak took home $40 million for the fiscal year ended April 30, an increase of nearly 80%. His base salary is only $1.5 million, while some of the money was from bonuses like stock options.
Mayo Clinic doctors published a study claiming that left ventricular assist devices can be used to treat restrictive cardiomyopathy, a heart condition affecting 500,000 Americans. This suggests the market for the blood pumps, which currently stands at about 6,500 implantations per year globally, has room to grow.
German specialty pharma Mallinckrodt has opted to sell off its contrast media and delivery systems business to Paris-based Guerbet for about $270 million as part of a strategic review of its business. The business has had declining revenues, but generates substantial cash and will mean a big step up for Guerbet.
OTC-traded Nephros has secured an agreement for Lincoln Park Capital to purchase up to $10 million of its shares over the next three years. That's roughly half of its minuscule $20 million market valuation.
Experts convened at FDA headquarters to discuss the challenges and opportunities posed by robotic surgery, and how the agency should regulate devices and tools that enable the new treatment paradigm.
Amid a growing body of research that shows deposits of gadolinium-based contrast agents (GBCAs) remain in the brain after repeat MRI procedures, the FDA is investigating the products' safety and risks.
Diagnostics are about to be available anywhere the patient is with a new device from Cepheid that it says is the first point-of-care diagnostic device intended for such a broadly defined area of use. The company is unveiling the device at this week's American Association for Clinical Chemistry meeting in Atlanta, GA.
Lately, strengthening the clinical trial enterprise has been the one of the main goals of the FDA's device arm (CDRH). It appears to be making some progress, as judged by the faster than expected approval of the latest generation of TAVRs made by Medtronic and Edwards Lifesciences.
Philips touted new managed services contracts with hospitals in the U.S. and Europe during its Q2 2015 earnings calls, as the company seeks to use its expertise in imaging and patient monitoring to create comprehensive partnerships with providers, and stand out against hardware-focused competitors like GE and Siemens.
Medtronic disclosed difficulties with almost 2,000 units of its latest model insulin pump, the MiniMed 640G, which had been distributed in 10 European countries, according to a recall notice just made by the FDA. This model had its European launch in January and is slated for a PMA submission later this year.
Amid growing pushback over the number of fetal ultrasounds performed in the U.S., physicians are weighing in on the issue with recommendations as to how and when the procedures should be used.
Bellerophon Therapeutics spun out of private-equity-backed Ikaria to develop two programs, but now one of these has failed in its first major trial. It reported top-line results of a trial for its bioabsorbable cardiac matrix to prevent heart failure after a heart attack.
Varian Medical Systems ($VAR) has signed a $124.4 million contract with the National Health Service to provide two new proton therapy centers in the country with the company's ProBeam system.
The Sorin Group's shares plummeted by 12% over the weekend on the Milan Stock Exchange after the Italian government sought to enjoin its merger with Houston's Cyberonics. The companies said they will mount a legal challenge to the Italian State's Attorney allegations.
SmartCardio has launched a crowdfunding campaign for its wearable system to diagnose potential heart disease.
Academics at Vanderbilt University's Medical Engineering and Discovery Laboratory have added a wrist to a needle-based surgical robot that's already been 6 years in development. Now, the researchers are ready to put the system to the test in head and neck surgeries, with transnasal surgeries to remove tumors from the pituitary gland likely up first in the clinic.
A letter published in Diabetes Care raises concerns about the accuracy of blood glucose meters at low glucose levels. The authors point to recent studies that reached this conclusion by testing the blood glucose meters made by Roche, Abbott, Bayer, Johnson & Johnson, Nipro Diagnostics and others.