Medtronic said that its recent CE mark for its CoreValve Evolut R System for transcatheter aortic valve implantation paves the way for the option to recapture or reposition artificial valves during heart surgery. The new feature is an advance in the relatively new arena of less-invasive heart surgery for patients who cannot withstand the rigors of open heart procedures.
A recently approved iPad app has been put to use to measure blood loss during cesarean section births. The app is being used as a substitute for evaluation techniques, such as sponge weighing, in cesarean surgeries at Magee-Womens Hospital in Pittsburgh, PA.
Endoscopic surgery isn't usually associated with diabetes, but Fractyl Laboratories yesterday announced encouraging clinical trial results for its endoscopic procedure to treat Type 2 diabetes and revealed a $40 million Series C financing round led by investment firm Mithril Capital Management.
Med tech is successfully navigating the plethora of alternative prototype capabilities, like 3-D printing, that were not available in previous decades.
Amid a wave of med tech M&A, Israeli colon capsule maker Check-Cap is bucking the trend and heading to market with plans for a $60 million IPO.
Atrial fibrillation causes uneven blood flow, which results in subtle changes in facial skin color. Researchers were able to use that to diagnose AF patients in a small pilot study by using video of a person's face in conjunction with a software analysis of skin color.
Johnson & Johnson squared off with aggrieved metal-on-metal hip customer Kathleen Herlihy-Paoli in a case that the plaintiffs says could lead to a $5 billion-plus payout. Herlihy-Paoli's claims that the hips leaked metal into her bloodstream, leading to an infection that required the artificial hip to be removed.
Use of nontherapeutic "sham" control tests in clinical trials of medical devices isn't always easy or cheap, but one perspective piece in The New England Journal of Medicine argues in favor of the practice in order to better test effectiveness of medical devices and procedures.
It can be difficult for patients with respiratory ailments to track their use of rescue medications. An inhaler sensor from Propeller Health does just that--serving as a remote monitor of drug use and feeding into a mobile app that tracks and analyzes medication use. The app even predicts when patients are likely to have difficulty, based on prior experience, and can be used to ensure proper inhaler usage, a common issue.
The device industry is awaiting the finalization of the FDA's rule on medical device classification procedures, and will be combing it for the requested changes from the March 2014 proposed rule. More comments asking for an easing of the regulatory burden may be forthcoming, for the FDA extended the public comment period to Sept. 22, according to a notice in the June 12 Federal Register.
Few sectors have been impacted by healthcare reform more than the orthopedics industry. And the looming merger of Zimmer and Biomet threatens to bring even more change and further consolidation. To get another perspective, FierceMedicalDevices spoke with Todd Ebert, the CEO of group purchasing organization Amerinet.
As cardiac devicemakers search for innovative ways to streamline products for patients, Swiss researchers have developed a self-powered pacemaker modeled after an automatic wristwatch that could provide an alternative to traditional pacing systems.
Getting rid of the finger stick for diabetics while maintaining sufficient accuracy without calibration is a long-held industry goal and could prove a boon to patients.
GE today announced the approval of its SenoClaire breast tomosynthesis device that employs 3-D imaging, developed in collaboration with Massachusetts General Hospital.
Personal mobility startup Whill has raised $11 million in a Series A round following a successful stint on Kickstarter. The financing will go to manufacture and expand distribution of its sleek, off-road device.
Customed received the most serious recall the FDA hands out--a Class I recall. This recall is the largest across-the-board recall the FDA has ever issued to date, 9 times larger than the previous record holding recall.
To improve postmarket monitoring of medical devices, three prominent stakeholders released a report today on the optimal use of medical device data registries to enable postmarket surveillance.
Long beleaguered by claims related to defective all-metal hip implants, Johnson & Johnson is shoring up for its latest courtroom battle as the company faces the first trial for one of its artificial hip devices.
The FDA has cleared HealthPatch MD, a small, wireless biosensor patch worn on the chest that can track a number of vital signs and biometric measurements. The sensor connects to a smartphone to relay data to a healthcare provider.
Cooking the books doesn't pay. That's the message the U.S. Department of Justice sent with the strict sentence it got for ArthroCare executives—albeit almost a decade after the problematic bookkeeping practices began.