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.
Oxford Performance Materials snagged an FDA OK for its 3-D printed spinal implant device, a win for the company as it adds to a string of regulatory approvals and builds out its offerings past skull and facial implants.
The maker of the first MRI-guided radiation cancer therapy system, ViewRay, has raised more cash since it cancelled a planned $52 million IPO in April than it expected to raise in that offering. It's raised a total of $76.7 million--$26.7 million of that in connection with a reverse merger that it just completed on July 23 and another $50 million in debt from royalty investor CRG in late June.
Stryker reiterated that acquisitions are its top priority for cash. But so far during the first half of this year, the orthopedics giant has spent a mere $92 million of its cash on acquisitions--while accruing an additional $1.8 billion in cash to sit on a pile of a whopping $3.6 billion in cash at the end of last quarter.
The consensus is that none of the other medical device bigwigs will try and steal heart pump maker Thoratec from the clutches of St. Jude Medical during the $3.4 billion deal's 30-day "go-shop" period.
Next year, Taiwan's Aidmics will ask the FDA to grant it permission to use its sperm-counting iSperm microscopes to count human sperm cells.
Perimeter Medical Imaging isn't alone in its aspirations to offer surgeons a better tool to visualize surgical tissue perimeters--but it is one of the newer entrants to the race. The startup has raised a $5 million Series A financing that it expects will be sufficient to complete an ongoing clinical trial, as well as to secure regulatory clearance for its first tissue imaging product.
Boston Scientific representatives provided updates on their recent product launches during the company's Q2 2015 earnings call. New Boston Scientific devices on the market include the latest generation of its S-ICD subcutaneous implantable defibrillator, SpyGlass DS endoscope, NOVI spinal cord stimulation system and the Watchman to prevent stroke.
In a continuing effort dubbed the Head Health Initiative,the NFL and partner GE have made awards of $500,000 to the 6 winners of the first of four planned research challenges. This is in addition to $300,000 in grants that it gave to 16 winners in the first round. Between them, they may be awarded a total of up to $10 million.
As the med tech industry homes in on innovative bionic prosthetic devices, scientists in Germany are developing an artificial hand that uses motion-sensing wires and electrical charges to guide movement.