FDA ends summary reporting, says it will not ban any breast implants

The agency laid out plans to improve the accessibility of safety information about breast implants and also announced it will make public all prior adverse event reports related to the devices within a matter of weeks.

By Maria Rachal • May 3, 2019

AI diagnostic tool for kidney disease earns breakthrough status

The technology uses electronic health record information and machine learning algorithms to assess blood-based biomarkers and identify patients at risk for kidney disease progression.

By Susan Kelly • May 3, 2019

Explore the Trendline➔

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

CMS to revamp coding for new medical technology

Medical device companies will now be able to apply for a new permanent Healthcare Common Procedure Coding System code twice a year instead of annually. 

By David Lim • May 3, 2019

Medtronic gets FDA approval for wireless pacemaker programmer

The device is the follow-up to CareLink 2090, which has been dogged by cybersecurity weaknesses.

By Nick Paul Taylor • May 3, 2019

Hologic posts another 'tale of two cities' quarter, analysts say

The Massachusetts-based women's health technology maker was buoyed by consistent growth in breast health and a strong showing in molecular diagnostics, but its medical aesthetics unit remains a drain.

By Maria Rachal • May 2, 2019

3M completes $6.7B takeout of Acelity

The deal adds new advanced wound care and specialty surgical application offerings to the Minnesota conglomerate's medical business.

By Maria Rachal • Updated Oct. 11, 2019

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

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