News

Medtronic receives CE mark for upgraded CoreValve TAVR

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.

FDA-approved iPad blood loss app has first use in cesarean surgeries

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.

Fractyl raises $40M for diabetes treatment via endoscopic surgery

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 startups flourish as access to IT gets cheaper, easier

Med tech is successfully navigating the plethora of alternative prototype capabilities, like 3-D printing, that were not available in previous decades.

Israeli colon capsule maker bucks M&A trend with plans for $60M IPO

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.

Researchers diagnose atrial fibrillation via webcam

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.

The metal-on-metal hip legal saga round one (of 6,000?): J&J vs. Herlihy-Paoli

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.  

NEJM op-ed calls for more sham-controlled device trials

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. 

Propeller Health gets $14.5M Series B for smart inhaler, app combo

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.

AdvaMed says FDA proposed rule would result in more PMAs, device reclassifications

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. 

Four lessons about the orthopedics industry from the CEO of group purchasing organization Amerinet

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.

Researchers develop self-powered pacemaker system based on automatic wristwatch

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.

Abbott glucose monitor eliminates finger sticks, receives CE mark

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 wins approval of 3-D imaging tech for breast screening

GE today announced the approval of its SenoClaire breast tomosynthesis device that employs 3-D imaging, developed in collaboration with Massachusetts General Hospital. 

Whill gets $11M Series A for its Segway of wheelchairs

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.

FDA issues largest one-day recall ever for 233 products

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.

Pew report makes recommendations on improving data registries

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.

J&J shoring up for latest courtroom battle over all-metal hip implant

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.

FDA clears wireless, vitals monitor patch that transmits to smartphone

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.

ArthroCare $750M fraud saga culminates in decades-long prison term

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.