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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.

Deep Dive

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.

Smith & Nephew buys skin substitute maker for $660M

The company announced Wednesday it closed the acquisition of Osiris Therapeutics. 

UPDATED: April 17, 2019 at 9:29 a.m.

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.

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.

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.

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.

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.

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.

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.

J&J wins FDA OK for first targeted therapy in bladder cancer

The agency also approved a companion diagnostic from Qiagen designed to test alterations in FGFR, which are targeted by first-of-its-kind drug Balversa.

Teladoc partners with Cincinnati Children's on pediatric telehealth platform

The pact comes as Teladoc has been expanding its global footprint and products through service rollouts and acquisitions outside the U.S.

Doctors see some promise, confusion for patient monitoring devices: study

Two-thirds of physicians "strongly intend" to monitor patients remotely in the future, but less than half predict patients will track every aspect of their health, according to an industry survey.

CMS support software mandate for imaging decisions backed by MIT study

Across more than 3,500 healthcare providers observed by researchers, those using clinical decision support software ordered fewer expensive CT scans.

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.

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.

DOJ indicts 24 people in $1.2B DME, telehealth fraud scheme

The defendants include CEOs and COOs of five telemedicine companies, the owners of dozens of durable medical equipment companies and three licensed medical professionals.

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.

FDA expands Abbreviated 510(k) guidance, seeks predicate input

FDA Thursday extended the comment period by 30 days for its request for feedback on its proposal to overhaul the 510(k) program to encourage use of more modern predicate devices.

UPDATED: April 12, 2019 at 9:51 a.m.

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.

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.

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.

Pfizer, Concerto collaborate on AI in precision oncology

The agreement is Concerto's second AI collaboration with a big pharma company in recent weeks and will focus on identifying new treatment options, refining study designs and speeding completion times for outcome studies.

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. 

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.