Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. FDA warns again on Pentax duodenoscopes
The FDA issued a statement today warning that Hoya subsidiary Pentax Medical’s ED-3490TK video duodenoscopes have a potential risk associated with the design and manufacturing of the device. Cracks in the adhesive that seals the scope’s distal cap and tip can lead to microbial and fluid ingress, according to information provided to the FDA by Pentax. These gaps can be difficult to clean, increasing the risk of infection transmission among patients.
The federal watchdog has identified improperly-cleaned duodenoscopes as a potential source for superbug infections. In February and March 2015, inadequately-cleaned duodenoscopes were tied to deadly suberbug outbreaks in hospitals in Connecticut, Virginia, California and Washington. The scopes associated with the infectious outbreak were made by Olympus and Pentax. Read more
4. Would-be HHS chief Price’s Zimmer Biomet trades draw insider trading scrutiny
The nominee to lead the U.S. Health & Human Services Dept., Rep. Tom Price (R-Ga.), reportedly bought shares in ZBH just days before introducing a bill to delay a program designed to change the way large joint implants are paid for; after the vote, the orthopedics giant’s political action committee donated to Price’s re-election campaign.
Price, a physician who is chairman of the House budget committee and a member of the House ways & means panel, introduced the “Healthy Inpatient Procedures Act” March 23, 2016. The bill, HR 4848, would delay and suspend the Centers for Medicare & Medicaid Services program to shift the business model for hip and knee implants from fee-for-service to an outcomes-based model. The Comprehensive Care for Joint Replacement program bundles payments for the replacements to cover from hospital admission to 90 days after discharge. Price’s bill, which was sent to the health subcommittee March 30, 2016, would also reduce and rescind funding Congress appropriated for the Prevention & Public Health Trust Fund. Read more
3. Abbott launches St. Jude Medical’s Ensite Precision cardiac mapping
Abbott yesterday said it launched the EnSite Precision cardiac mapping system it acquired when it paid $25 billion for St. Jude Medical earlier this month.
The commercial launch also included the sensor-enabled Advisor FL circular mapping catheter, Abbott said. The system, which won 510(k) clearance from the FDA in December 2016, was used for the 1st time commercially at Salt Lake City’s Intermountain Medical Center, Abbott said. Read more
2. Abbott touts dorsal root ganglion stim study
Abbott today touted short- and long-term data published in the journal Pain, which demonstrated that its dorsal root ganglion stimulation therapy benefits patients suffering from complex regional pain syndrome more than traditional spinal cord stimulation.
The Abbott Park, Ill.-based company said it’s the only company in the world approved to offer DRG stimulation. The newly-published data is from the company’s ACCURATE study, which evaluated DRG stimulation in patients for 3 and 12 months. Read more
1. Dexcom surges on Medicare nod for continuous glucose monitors
DexCom said yesterday that the Centers for Medicare & Medicaid classified therapeutic continuous glucose monitors as durable medical equipment under Medicare Part B. The company’s Dexcom G5 Mobile is the only CGM system that falls under this classification, according to San Diego, Calif.-based DexCom, since patients can make treatment decisions using the device.
DXCM shares were down -2.1% at closing yesterday, but came back 12.3% this morning in pre-market trading. Read more
The post MassDevice.com +5 | The top 5 medtech stories for January 17, 2017 appeared first on MassDevice.
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