FDA progressive device approval proposal raises eyebrows

Former FDA Commissioner Scott Gottlieb told MedTech Dive during his last week in office he believes stepwise approval should only be used for animal drugs, not human medical products.

By David Lim • April 16, 2019

J&J device revenue slumps amid big bet on digital surgery

Growth in contact lenses and atrial fibrillation ablation catheters were bright spots as Johnson & Johnson felt the impact of its first quarter $3.4 billion Auris Health buy and sale of the LifeScan diabetes business.

By Maria Rachal • April 16, 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

FDA approves post-angioplasty dissection repair device

Intact Vascular's device is approved to treat above-knee tears in the artery wall in peripheral artery disease patients who have undergone balloon angioplasty.

By Susan Kelly • April 16, 2019

Edible hydrogel capsule to treat obesity gets FDA go-ahead

The De Novo-winning Plenity hydrogel capsule releases particles that rapidly absorb water in the stomach to create gel pieces with the firmness of plant-based foods, making you feel full faster.

By Susan Kelly • April 16, 2019

EU device group clarifies incoming database requirements

The publication of the guidelines comes as Europe races to be ready for the implementation of new medical device regulations.

By Nick Paul Taylor • April 16, 2019

CDRH Director Shuren: Safety and innovation are 'two sides of same coin'

The device chief said in a wide-ranging interview with MedTech Dive a major challenge for the agency is fighting the perception that speeding new devices to market comes at the cost of patient safety, or vice versa.

By David Lim • April 15, 2019

Contaminated duodenoscopes linked to 3 new deaths, 45 more infections, FDA says

The agency signaled impatience with manufacturers Olympus, Fujifilm and Pentax for failing to comply with timelines for completing post-market studies.

By Susan Kelly • April 15, 2019

FDA flags breathing tube shortage tied to sterilization plant closing

The temporary scarcity of Smiths Medical tracheostomy tubes, especially for pediatric use, is FDA's first confirmation of a specific device shortage tied to the shutdown of Illinois contract sterilization company Sterigenics.

By Susan Kelly • April 15, 2019

AliveCor's AI software for EKG rhythms gets market OK

FDA posted the 510(k) summary for KardiaAI last week. The software supports analysis of data recorded in compatible formats from ambulatory EKG devices such as event recorders.

By Susan Kelly • April 15, 2019

Digital care coordination software market to top $3B by 2022, but hurdles remain

Driving growth is poor referral management, a desire for real-time communication on patient outcomes and potential savings from improving chronic disease management, according to a Frost & Sullivan report.

By Meg Bryant • April 11, 2019

FDA sounds alarm on unregulated brain injury devices

The agency said Wednesday it is aware of companies marketing smartphone or tablet-based devices claiming to assess or diagnose concussions and other traumatic brain injuries without proper regulatory approval.

By Maria Rachal • April 11, 2019

Avinger's image-guided device for PAD gets FDA nod

The new device is designed to help physicians remove plaque from smaller arteries and builds on the company's technology that produces real-time images from inside the artery.

By Susan Kelly • April 11, 2019

Device tax repeal reintroduced in House, Senate (again)

AdvaMed Chairman and Stryker CEO Kevin Lobo said the repeal of the tax, set to go back into effect at the end of the year, is the top priority for the device lobby. But signs of movement may be months away.

By David Lim • April 11, 2019

Australia stops short of breast implant ban

Diverging from Canadian and French restrictions on certain breast implants, Allergan, Mentor and other manufacturers have 10 working days to provide information before regulators reconsider pulling products from the market.

By Maria Rachal • April 10, 2019

Prices soar for new medtech, but payment lags: report

New medtech, especially heart devices, is improving patients' quality of life and helping them live longer, but hospitals are enmeshed in a "reimbursement quagmire," according to a report by consultancy Vizient.

By Susan Kelly • April 10, 2019

CMS floats broadening ambulatory blood pressure monitoring coverage

The proposed decision memo comes nearly a year after the American Heart Association and American Medical Association requested the agency consider expanding reimbursement.

By David Lim • April 9, 2019

FDA warns patients to steer clear of pre-owned test strips

An underground economy is thriving for test strips used by diabetes patients for blood sugar monitoring.

By Susan Kelly • April 9, 2019

Medtronic, Blue Cross strike value-based pact for glucose monitors

The arrangement ties payments to the amount of time a patient's blood sugar stays in a healthy range.

By Susan Kelly • April 9, 2019

Alcon spin-out marks step in Novartis plan to remake business

Alcon will rank as one of the largest eye care device makers globally, with more than 20,000 employees and sales totaling $7.1 billion last year. 

By Ned Pagliarulo • April 9, 2019

Abiomed reports improved survival rates in cardiogenic shock patients

The company said data from an observational database and post-approval studies show development of a best practices protocol can significantly improve patient outcomes.

By Susan Kelly • April 8, 2019

Nvidia, American College of Radiology partner on AI platform

The computer graphics chipmaker and doctors group are working on an open architecture artificial intelligence system to help radiologists create diagnostic algorithms at their local institutions.

By Susan Kelly • April 8, 2019

Medtronic analysis tracks reduced strokes in HVAD patients

Ailing from declining sales of its left ventricular assist devices, the company said a retrospective analysis showed blood pressure management helped reduce serious strokes in patients implanted with its HeartWare system.

By Susan Kelly • April 8, 2019

Medtronic touts pain pump cost effectiveness for cancer patients in JAMA

While the medtech giant is likely to push its pain pump as an alternative to oral opioids, the National Comprehensive Cancer Network only recommends such targeted drug therapy for a subset of patients.

By David Lim • April 8, 2019

Canada, France take hard action on textured breast implants

Australia's Therapeutic Goods Administration called a meeting of its BIA-ALCL expert working group to "inform decision making" in response to recent reviews of breast implants by FDA and other international regulators.

By Maria Rachal • Updated April 8, 2019

Australia strategizes to tighten medical device oversight

Regulators are considering mandating greater clinical evidence for certain high-risk devices, including spinal implants, diabetes management devices, medical devices used for IVF and companion diagnostics.

By David Lim • April 5, 2019