Medical Devices: Page 176
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Currency hit wipes out growth at Fresenius' dialysis device unit
The renal disease specialist reaffirmed its 2018 guidance but needs a strong second half of the year to meet its goals.
By Nick Paul Taylor • Aug. 1, 2018 -
Microsoft files patent for eyeglasses-based blood pressure monitor
The device could free patients from the need to use oscillometric cuffs to track their health.
By Nick Paul Taylor • Aug. 1, 2018 -
Explore the Trendlineâž”
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
FDA warns about vaginal 'rejuvenation' device claims
The seven device makers notified by FDA are Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.
By Susan Kelly • July 31, 2018 -
Conservative think tank praises CMS proposal on DME bidding
The industry-funded Pacific Research Institute contends that the current bidding system is driving suppliers out of the market and creating supply shortages. The proposal could increase costs to Medicare.
By David Lim • July 31, 2018 -
MedTech Europe seeks 'urgent' changes to EU regs deadlines
The trade group proposes either stopping the clock on the countdown to the end of the transition periods or delaying the implementation dates for all products, or just legacy products.
By Nick Paul Taylor • July 31, 2018 -
Sienna's acne medical device flops in pivotal trials
The California-based company isn't giving up on the product, however. Its CEO said Sienna remains optimistic in its use for hair treatment.
By Andrew Dunn • July 30, 2018 -
FDA approves Abbott's blood sugar sensor for 14-day use
The system was the first continuous glucose monitor to eliminate the need for routine finger prick tests.
By Susan Kelly • July 30, 2018 -
FDA sets 2019 medical device user fee rates
The agency said the base fee for a premarket application received during FY 2019 is $300,000 with the base fee for an establishment registration at $4,548.
By Susan Kelly • July 30, 2018 -
CMS advisers split on procedure volume rules for TAVR
Edwards LifeSciences and Medtronic offered different takes on the current coverage policy.
By Susan Kelly • July 30, 2018 -
CMS pitches covering cardiac catheterization at surgical centers
Jefferies analysts expect the agency will eventually add coverage for knee replacements at ambulatory surgical centers.
By Susan Kelly • July 30, 2018 -
CDHR extends staff training program into 2019
The Experiential Learning Program provides ongoing training for FDA staff about the device development cycle.
By Rebecca Pifer • July 30, 2018 -
OpinionProtecting patients from emergent cybersecurity threats is the shared responsibility of the entire healthcare supply chain
Breaches in medical device cybersecurity pose a significant threat to hospitals and the patients they serve.
By Todd Ebert & Curt Miler • July 27, 2018 -
ECRI safety panel advises 3 ways to avoid diagnostic testing, medicine mix-ups
"The problem of not closing the loop has a significant impact on patients and caregivers, and can lead to devastating effects on the outcome of patients, workgroup chair Chris Lehmann said.
By David Lim • July 27, 2018 -
FDA gives draft guidance on atherectomy device submissions
The advice is intended to help manufacturers develop a risk analysis and performance testing strategy for devices used to remove plaque from diseased peripheral arteries.
By Susan Kelly • July 27, 2018 -
Baxter boosts 2018 outlook but IV bag supply still under pressure
"We hope that by the end of the year, early next year, MINI-BAG Plus and MINI-BAG will be off allocation," Baxter CEO ​José Almeida told investors.
By David Lim • July 26, 2018 -
NIH teams with Google Cloud for new biomedical research project
The agency is partnering with Google, which appointed former Cleveland Clinic CEO Toby Cosgrove to advise Google Cloud healthcare initiatives.
By Meg Bryant • July 25, 2018 -
Roche's rice-sized Lucentis implant headed for advanced testing
Phase 2 data showed the majority of wet AMD patients implanted with the device went six months before needing a refill of the drug.
By Jacob Bell • July 25, 2018 -
Stryker says Q2 tops goals, will stick to M&A playbook
The device maker boasted of strong demand for its robot for knee surgery but said its spine business remained "challenged."
By Susan Kelly • July 25, 2018 -
Boston Scientific beats Q2 targets as neuromodulation devices gain share
Demand for the WaveWriter spinal cord stimulator fueled the results. Cardiovascular was the weakest performer.
By Nick Paul Taylor • July 25, 2018 -
Endomagnetics' Sentimag System scores approval from FDA
The system, which helps guide lymph node biopsies for breast cancer patients undergoing mastectomy, utilizes magnetic rather than radioactive materials.
By David Lim • July 25, 2018 -
House repeals medical device tax, Senate path muddied
The device industry has successfully put off the tax, one of several imposed on industry in the Affordable Care Act, for years.
By David Lim • Updated July 24, 2018 -
5 key parts of the FDA Medical Device Safety Action Plan
The ambitious proposal focuses on a total lifecycle approach to device safety.
By Meg Bryant • July 23, 2018 -
Bayer to stop selling Essure birth control implant in US
The German pharma said it stands by the product's safety, despite thousands of lawsuits claiming it caused harm.
By Susan Kelly • July 23, 2018 -
Tendyne investors sue Abbott over lost milestone payment
After the success of transcatheter aortic valve replacement therapy, device companies are now focusing efforts on minimally invasive procedures to replace the mitral valve.
By Susan Kelly • July 23, 2018 -
Intuitive Surgical profit up on strong da Vinci robot sales
The company has long dominated the market, but bigger players like Medtronic and Verb Surgical are now developing their own surgical robots.
By Susan Kelly • July 20, 2018
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