Medical Devices: Page 155
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FDA launches 'super office' to link pre and postmarket review
Agency leaders said the pilot tested over the past year has yielded "significant improvements" in identifying safety issues, and industry should see benefits as well.
By David Lim • May 2, 2019 -
Abiomed misses sales target following 'confusion' caused by FDA letter
Revenue growth slowed significantly as safety concerns caused demand for protected percutaneous coronary interventions to fall.
By Nick Paul Taylor • May 2, 2019 -
Explore the Trendline➔
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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
Tunbridge named interim MHRA medical device chief as Wilkinson retires
Graeme Tunbridge has been with the agency since 2011 and has spent the bulk of his time working on measures to strengthen medical device regulation.
By Nick Paul Taylor • Updated Oct. 21, 2019 -
Smith & Nephew raises outlook as soaring sales in China drive growth
The first quarter performance made Smith & Nephew "increasingly confident" it will hit the upper end of its 2019 sales guidance.
By Nick Paul Taylor • May 2, 2019 -
Japanese ortho device market grows, despite steep barriers to entry
The second largest market for U.S.-made medical devices comes with unique regulatory and reimbursement hurdles.
By Meg Bryant • May 1, 2019 -
Plastic surgery device maker draws FDA warning letter
Plano, Texas-based Surgisil has been selling two of its devices for lip augmentation, an indication regulators said is not covered by the company's facial implant 510(k) clearance.
By Susan Kelly • May 1, 2019 -
DHS highlights cybersecurity weakness in Philips EMR
Hackers could exploit a vulnerability in the company's electronic medical record system to access sensitive information or execute arbitrary code, the Cybersecurity and Infrastructure Security Agency said.
By Nick Paul Taylor • May 1, 2019 -
Device to preserve donor lungs wins FDA approval
The system could expand availability of donor lungs by preserving the organ for up to five hours, giving the transplant team time to reassess marginal lungs that failed a standard initial review.
By Susan Kelly • April 30, 2019 -
CMS reopens coverage determination on next generation sequencing for cancer patients
Healthcare organizations argued the agency's original decision would prevent Medicare beneficiaries with early-stage cancer from accessing NGS tests.
By Susan Kelly • April 30, 2019 -
UK issues alert on risks with J&J surgical stapler
Days after FDA floated increasing oversight of surgical staplers, U.K. regulators flagged a warning from Ethicon that its devices' staple lines may fail.
By Susan Kelly • April 29, 2019 -
Edwards recalls two heart catheters used in infants
The devices are used to correct complex congenital heart defects after birth.
By Susan Kelly • April 29, 2019 -
Cardiology groups oppose CMS policy shift on TAVR volume
Big device players in the market have had varying comments on the proposed national coverage determination for transcatheter aortic valve replacement, which seeks to relax requirements to start a program.
By Susan Kelly • April 29, 2019 -
Legacy systems, employee error leave hospitals, devices vulnerable to cyberattacks
The challenge of guarding health systems is compounded by connected medical devices not being vetted for cybersecurity controls before joining networks, according to new research from threat detection firm Vectra.
By Meg Bryant • April 26, 2019 -
FDA cautions against off-label use of Stryker's Wingspan stent system
The agency flagged increased risk of stroke and death from non-indicated uses of the intracranial stenosis device, citing postmarket data from a study mandated by regulators in 2012.
By Maria Rachal • Updated April 29, 2019 -
Zimmer Biomet narrowly beats expectations in 'good enough' quarter
Declining sales in the U.S. dragged on business in the first quarter, but management predicts improved performance in the second half of 2019, fueled in part by moving from a limited to full launch of the Rosa robotic system.
By Nick Paul Taylor • April 26, 2019 -
Manufacturers get finalized guidance from FDA on orthopaedic device material
The text is intended to help companies understand what data to submit when seeking clearance for devices made with a biomaterial commonly found in spinal implants and knee and hip replacements.
By Nick Paul Taylor • April 26, 2019 -
Mayo Clinic accelerator picks include AI, remote patient monitoring tools
Six startups were selected for the first round of a program aimed at exposing early stage medtech companies to investment and go-to-market opportunities.
By Meg Bryant • April 25, 2019 -
Falling medication delivery sales drag Baxter revenues down again in Q1
Growth at the advanced surgery unit helped offset weakness in medication delivery sales, which the company remains optimistic will grow 6% in 2019.
By Nick Paul Taylor • April 25, 2019 -
Sirolimus-eluting balloon wins breakthrough status
The designation boosts Orchestra BioMed's efforts to develop and market its Virtue device to treat below-the-knee peripheral artery disease, in addition to coronary in-stent restenosis.
By Nick Paul Taylor • Updated Sept. 17, 2019 -
Boston Scientific Q1 hit by woes over mesh, paclitaxel, sterilization
The company lowered full year revenue guidance and slashed expectations for its Eluvia paclitaxel-eluting stent by 50% ahead of an FDA advisory panel.
By Maria Rachal • Updated April 25, 2019 -
FDA pitches stronger controls, new labeling for surgical staplers
The proposed order follows an agency review that found the widely used tools were linked to numerous problems and serious complications, including 366 deaths, over a seven-year period.
By Susan Kelly • April 24, 2019 -
Edwards Lifesciences beats profit forecasts amid low-risk TAVR momentum
The structural heart-focused company posted close to $1 billion in first quarter sales, exceeding Wall Street expectations.
By Susan Kelly • April 24, 2019 -
CMS floats new add-on payment route for breakthrough devices
The agency's proposed rule for 2020 outpatient payments pitches a similar alternative pathway aimed at speeding coverage for select medical technologies.
By David Lim • Updated July 31, 2019 -
Playing catch up, Boston Scientific gets FDA approval for Lotus TAVR device
The U.S. OK comes 30 months after an issue with the delivery system locking mechanism led Boston Scientific to stop installations of the product in Europe.
By Nick Paul Taylor • April 24, 2019 -
Surgical instruments lead organic growth for Stryker in Q1
Despite the beat-and-raise start to 2019, Stryker posted second quarter earnings guidance that fell short of expectations.
By Nick Paul Taylor • April 24, 2019
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