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

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Medical 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

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

Study supports genetic testing for sudden cardiac arrest

The research, published in the Journal of Cardiology, found the tests to be useful regardless of whether patients showed previous clinical evidence of heart disease.  

By Susan Kelly • April 23, 2019

FDA advisory panels set for surgical staplers, paclitaxel devices

Regulators are seeking expert advice regarding paclitaxel-coated devices in peripheral artery disease patients, and on surgical staplers, which FDA suggests should be reclassified after a spike in adverse event reports.

By Maria Rachal • April 23, 2019

Obesity device to slow stomach emptying gets approval

BaroNova's clinical study met its primary endpoints for percent total body weight loss 12 months after the procedure.

By Susan Kelly • April 23, 2019

More patients die after starting dialysis than registry suggests: Harvard study

The death rates for dialysis patients in a new JAMA Internal Medicine analysis were almost twice as high as mortality statistics from the U.S. Renal Data Registry.

By Susan Kelly • April 23, 2019